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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000694-30 | EudraCT Number | ||
| U1111-1113-8587 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
Over the past 30 years, the prevalence of diabetes has increased dramatically throughout the world due to population growth, aging, urbanization, increasing obesity, and physical inactivity. The total number of people with type 2 diabetes mellitus is projected to rise from 171 million in 2000 to 366 million in 2030. The incidence of type 2 diabetes mellitus in the United States alone is expected to increase from approximately 17 to 30.3 million by the year 2030. Type 2 diabetes mellitus is associated with a number of long-term microvascular and macrovascular complications associated with a reduced quality of life and increased morbidity and mortality. It is anticipated that the increasing incidence of type 2 diabetes mellitus will place an ever-increasing burden on families, increase national expenditures for health care services, and decrease worker productivity.
Current pharmacologic interventions for type 2 diabetes mellitus include a diverse range of antidiabetic medications with different mechanisms of action including insulin and insulin analogues, sulfonylureas, metformin, meglitinides, thiazolidinediones, inhibitors of alpha-glucosidase, analogs of glucagon-like peptide-1 and synthetic analogues of human amylin. Despite the variety of medications, many have clinically important or potentially life-threatening side effects, restricted use in many subpopulations, concerns with long-term tolerability, and challenges related to compliance due to side effects and route of administration. All of these reasons contribute to the difficulties patients have achieving the target glycosylated hemoglobin level less than 7%.
SYR-322 (alogliptin) is a selective, orally available inhibitor of the dipeptidyl peptidase-4 enzyme. Dipeptidyl peptidase-4 enzyme is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Both peptides exert important effects on islet beta cells to stimulate glucose-dependent insulin secretion as well as regulating beta cell proliferation and cytoprotection. Glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, inhibits gastric emptying, glucagon secretion, and food intake. Glucose-dependent insulinotropic peptide has been shown to enhance insulin secretion by direct interaction with a glucose-dependent insulinotropic peptide -specific receptor on islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes mellitus.
Pioglitazone (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan) that is approved for the treatment of type 2 diabetes mellitus. Pioglitazone is a selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output.
Given the complementary mechanisms of action of alogliptin (stimulation of insulin secretion) and pioglitazone (enhancement of insulin sensitivity), the goal of this study is to evaluate the efficacy of the combination of alogliptin with pioglitazone in patients who are inadequately controlled on metformin. Study participation is anticipated to be approximately 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 12.5 + Placebo | Experimental | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 25 + Placebo | Experimental | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
|
| Placebo + Pioglitazone 15 | Active Comparator | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 12.5 + Pioglitazone 15 | Experimental | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone). | Baseline and Week 26 |
| Change From Baseline to Week 26 in HbA1c | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). | Baseline and Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c Over Time (Grouped Analysis) | The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VP Biological Sciences | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22419732 | Result | DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1615-22. doi: 10.1210/jc.2011-2243. Epub 2012 Mar 14. |
| Label | URL |
|---|---|
| ACTOS® Package Insert | View source |
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Participants with a diagnosis of type 2 diabetes who were inadequately controlled on a regimen of metformin alone were equally randomized to 1 of 12 double-blind treatment groups.
Participants took part in the study at 327 investigative sites in 20 countries from 31 May 2006 to 17 March 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| FG001 | Alogliptin 12.5 + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Alogliptin 25 + Pioglitazone 15 | Experimental | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
|
| Placebo + Pioglitazone 30 | Active Comparator | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 12.5 + Pioglitazone 30 | Experimental | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 25 + Pioglitazone 30 | Experimental | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
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| Placebo + Pioglitazone 45 | Active Comparator | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 12.5 + Pioglitazone 45 | Experimental | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
| Alogliptin 25 + Pioglitazone 45 | Experimental | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
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| Alogliptin placebo | Drug | Alogliptin placebo-matching tablets. |
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| Pioglitazone | Drug | Pioglitazone tablets. |
|
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| Pioglitazone placebo | Drug | Pioglitazone placebo-matching tablets. |
|
| Baseline and Weeks 4, 8, 12, 16 and 20. |
| Change From Baseline to Week 4 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 20 |
| Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis) | The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 1 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 1 |
| Change From Baseline to Week 2 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 2 |
| Change From Baseline to Week 4 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 26 |
| Percentage of Participants With Marked Hyperglycemia (Grouped Analysis) | Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | From Week 1 to Week 26 |
| Percentage of Participants With Marked Hyperglycemia | Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). | From Week 1 to Week 26 |
| Percentage of Participants Meeting Rescue Criteria (Grouped Analysis) | Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
| From Week 1 to Week 26. |
| Percentage of Participants Meeting Rescue Criteria | Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
| From Week 1 to Week 26 |
| Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Week 26 |
| Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. | Week 26 |
| Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Week 26 |
| Percentage of Participants With Glycosylated Hemoglobin ≤ 7% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. | Week 26 |
| Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Week 26 |
| Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. | Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Baseline and Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. | Baseline and Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Baseline and Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. | Baseline and Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Baseline and Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. | Baseline and Week 26 |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Baseline and Week 26. |
| Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%. | Baseline and Week 26 |
| Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis) | Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Insulin Over Time (Grouped Analysis) | The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis) | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in C-peptide Over Time (Grouped Analysis) | C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Total Cholesterol Over Time (Grouped Analysis) | Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis) | Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis) | Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Triglycerides Over Time (Grouped Analysis) | Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
| Change From Baseline to Week 4 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 4 |
| Change From Baseline to Week 8 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 16 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 16 |
| Change From Baseline to Week 20 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis) | Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in Free Fatty Acids | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Free Fatty Acids | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis) | Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis) | Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Adiponectin Over Time (Grouped Analysis) | Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in Adiponectin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Adiponectin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Body Weight Over Time (Grouped Analysis) | Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Weeks 8, 12, 20 and 26. |
| Change From Baseline to Week 8 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 8 |
| Change From Baseline to Week 12 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 20 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 20 |
| Change From Baseline to Week 26 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis) | HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance | The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance | The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis) | The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function | The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function | The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in Apolipoprotein A1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Apolipoprotein A1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Apolipoprotein A2 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Apolipoprotein A2 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Apolipoprotein B | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Apolipoprotein B | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis) | Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Apolipoprotein C-III | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Apolipoprotein C-III | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis) | Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides | NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides | NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in VLDL / Chylomicron Particles | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in VLDL / Chylomicron Particles | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis) | The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides | The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides | The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in VLDL Particles Over Time (Grouped Analysis) | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in VLDL Particles | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in VLDL Particles | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates | Baseline and Week 26 |
| Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Mean VLDL Particle Size | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Mean VLDL Particle Size | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in IDL Particles | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in IDL Particles | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in LDL Particles | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in LDL Particles | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Mean LDL Particle Size | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Mean LDL Particle Size | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. | Baseline and Weeks 12 and 26. |
| Change From Baseline to Week 12 in HDL Particles | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in HDL Particles | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. | Baseline and Week 26 |
| Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Baseline and Weeks 12 and 26 |
| Change From Baseline to Week 12 in Mean HDL Particle Size | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Baseline and Week 12 |
| Change From Baseline to Week 26 in Mean HDL Particle Size | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Baseline and Week 26 |
| Columbiana |
| Alabama |
| United States |
| Huntsville | Alabama | United States |
| Phoenix | Arizona | United States |
| Little Rock | Arkansas | United States |
| Searcy | Arkansas | United States |
| Sherwood | Arkansas | United States |
| Burbank | California | United States |
| Foothill Ranch | California | United States |
| Irvine | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Temecula | California | United States |
| Tustin | California | United States |
| Colorado Springs | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Hollywood | Florida | United States |
| Kissimmee | Florida | United States |
| Miami | Florida | United States |
| New Port Richey | Florida | United States |
| Pembroke Pines | Florida | United States |
| Pinellas Park | Florida | United States |
| Sarasota | Florida | United States |
| Vero Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Roswell | Georgia | United States |
| Savannah | Georgia | United States |
| Warner Robins | Georgia | United States |
| Chicago | Illinois | United States |
| Peoria | Illinois | United States |
| Lafayette | Indiana | United States |
| South Bend | Indiana | United States |
| Waterloo | Iowa | United States |
| Munfordville | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Marrero | Louisiana | United States |
| Elkridge | Maryland | United States |
| Prince Frederick | Maryland | United States |
| Towson | Maryland | United States |
| Marlborough | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Cadillac | Michigan | United States |
| Detroit | Michigan | United States |
| Livonia | Michigan | United States |
| Kansas City | Missouri | United States |
| North Las Vegas | Nevada | United States |
| Blackwood | New Jersey | United States |
| Trenton | New Jersey | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Statesville | North Carolina | United States |
| Gallipolis | Ohio | United States |
| Marion | Ohio | United States |
| Clinton | Oklahoma | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Allentown | Pennsylvania | United States |
| Altoona | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Alcoa | Tennessee | United States |
| Milan | Tennessee | United States |
| Morristown | Tennessee | United States |
| Arlington | Texas | United States |
| Carrollton | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Temple | Texas | United States |
| Salt Lake City | Utah | United States |
| Burlington | Vermont | United States |
| Multiple Cities | Australia |
| Multiple Cities | Brazil |
| Multiple Cities | Bulgaria |
| Multiple Cities | Chile |
| Multiple Cities | Croatia |
| Multiple Cities | Estonia |
| Multiple Cities | Guatemala |
| Multiple Cities | India |
| Multiple Cities | Israel |
| Multiple Cities | Latvia |
| Multiple Cities | Mexico |
| Multiple Cities | New Zealand |
| Multiple Cities | Peru |
| Multiple Cities | Romania |
| Multiple Cities | Russia |
| Multiple Cities | Serbia |
| Multiple Cities | South Africa |
| Multiple Cities | Ukraine |
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
| FG002 | Alogliptin 25 + Placebo | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| FG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| FG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| FG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| FG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| FG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| FG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| FG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| FG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| FG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| BG001 | Alogliptin 12.5 + Placebo | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| BG002 | Alogliptin 25 + Placebo | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| BG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| BG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| BG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| BG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| BG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| BG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| BG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| BG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| BG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Diabetes Duration | Mean | Standard Deviation | years |
| |||||||||||||||
| Baseline metformin dose | Mean | Standard Deviation | mg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone). | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 26 |
|
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| Secondary | Change From Baseline in HbA1c Over Time (Grouped Analysis) | The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Weeks 4, 8, 12, 16 and 20. |
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| Secondary | Change From Baseline to Week 4 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward (LOCF) imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 20 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis) | The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 1 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 1 |
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| Secondary | Change From Baseline to Week 2 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 2 |
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| Secondary | Change From Baseline to Week 4 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Percentage of Participants With Marked Hyperglycemia (Grouped Analysis) | Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group. | Posted | Number | percentage of participants | From Week 1 to Week 26 |
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| Secondary | Percentage of Participants With Marked Hyperglycemia | Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). | Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group. | Posted | Number | percentage of participants | From Week 1 to Week 26 |
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| Secondary | Percentage of Participants Meeting Rescue Criteria (Grouped Analysis) | Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
| Full analysis set including patients with at least 1 postbaseline visit. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | Posted | Number | percentage of participants | From Week 1 to Week 26. |
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| Secondary | Percentage of Participants Meeting Rescue Criteria | Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
| Full analysis set including patients with at least 1 postbaseline visit. | Posted | Number | percentage of participants | From Week 1 to Week 26 |
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| Secondary | Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With Glycosylated Hemoglobin ≤ 7% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Primary | Change From Baseline to Week 26 in HbA1c | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 26 |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26. |
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| Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%. | The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation. | Posted | Number | percentage of participants | Baseline and Week 26 |
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| Secondary | Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis) | Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline and Week 26 |
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| Secondary | Change From Baseline in Insulin Over Time (Grouped Analysis) | The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | µIU/mL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis) | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and Week 26 |
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| Secondary | Change From Baseline in C-peptide Over Time (Grouped Analysis) | C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Total Cholesterol Over Time (Grouped Analysis) | Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis) | Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis) | Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Triglycerides Over Time (Grouped Analysis) | Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 4, 8, 12, 16, 20 and 26. |
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| Secondary | Change From Baseline to Week 4 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 4 |
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| Secondary | Change From Baseline to Week 8 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 16 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 16 |
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| Secondary | Change From Baseline to Week 20 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis) | Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in Free Fatty Acids | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Free Fatty Acids | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and Week 26 |
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| Secondary | Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis) | Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and Week 26 |
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| Secondary | Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis) | Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/L | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/L | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/L | Baseline and Week 26 |
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| Secondary | Change From Baseline in Adiponectin Over Time (Grouped Analysis) | Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | μg/mL | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in Adiponectin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | μg/mL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Adiponectin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | μg/mL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Body Weight Over Time (Grouped Analysis) | Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | kg | Baseline and Weeks 8, 12, 20 and 26. |
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| Secondary | Change From Baseline to Week 8 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | kg | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 12 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | kg | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 20 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | kg | Baseline and Week 20 |
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| Secondary | Change From Baseline to Week 26 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | kg | Baseline and Week 26 |
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| Secondary | Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis) | HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | insulin resistance | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance | The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | insulin resistance | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance | The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | insulin resistance | Baseline and Week 26 |
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| Secondary | Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis) | The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage beta cell function | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function | The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage beta cell function | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function | The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | percentage beta cell function | Baseline and Week 26 |
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| Secondary | Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in Apolipoprotein A1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Apolipoprotein A1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in Apolipoprotein A2 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Apolipoprotein A2 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in Apolipoprotein B | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Apolipoprotein B | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis) | Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in Apolipoprotein C-III | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Apolipoprotein C-III | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis) | Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 12 and 26. |
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| Secondary | Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides | NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides | NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in VLDL / Chylomicron Particles | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in VLDL / Chylomicron Particles | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 26 |
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| Secondary | Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis) | The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides | The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides | The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 26 |
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| Secondary | Change From Baseline in VLDL Particles Over Time (Grouped Analysis) | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in VLDL Particles | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in VLDL Particles | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 26 |
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| Secondary | Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in Mean VLDL Particle Size | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in Mean VLDL Particle Size | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Week 26 |
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| Secondary | Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in IDL Particles | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 12 |
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| Secondary | Change From Baseline to Week 26 in IDL Particles | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 26 |
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| Secondary | Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Weeks 12 and 26 |
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| Secondary | Change From Baseline to Week 12 in LDL Particles | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 26 in LDL Particles | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nmol/L | Baseline and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Weeks 12 and 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Mean LDL Particle Size | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 26 in Mean LDL Particle Size | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | μMOL/L | Baseline and Weeks 12 and 26. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in HDL Particles | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | μmol/L | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 26 in HDL Particles | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | μmol/L | Baseline and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Weeks 12 and 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Mean HDL Particle Size | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 26 in Mean HDL Particle Size | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized. | Posted | Least Squares Mean | Standard Error | nm | Baseline and Week 26 |
|
Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. | 2 | 129 | 41 | 129 | ||
| EG001 | Alogliptin 12.5 + Placebo | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. | 5 | 128 | 40 | 128 | ||
| EG002 | Alogliptin 25 + Placebo | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. | 6 | 129 | 46 | 129 | ||
| EG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. | 1 | 129 | 51 | 129 | ||
| EG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. | 2 | 130 | 45 | 130 | ||
| EG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. | 1 | 130 | 44 | 130 | ||
| EG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. | 2 | 129 | 40 | 129 | ||
| EG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. | 3 | 130 | 35 | 130 | ||
| EG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. | 6 | 130 | 51 | 130 | ||
| EG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. | 10 | 129 | 40 | 129 | ||
| EG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. | 2 | 130 | 47 | 130 | ||
| EG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. | 5 | 130 | 41 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lung cyst benign | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520853 | alogliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| ≥65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
| Superiority or Other |
| ANCOVA | ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | <0.001 | LS Mean Difference | -0.53 | 2-Sided | 95 | -0.66 | -0.41 | No | Superiority or Other |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 mg + Pioglitazone 30 mg | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 mg | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 mg + Pioglitazone 30 mg | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 mg | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 mg + Pioglitazone 30 mg | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 mg | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 mg + Pioglitazone 30 mg | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 mg | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Participants |
|
|
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg). |
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Counts |
|---|
| Participants |
|
|
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Counts |
|---|
| Participants |
|
|
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Counts |
|---|
| Participants |
|
|
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 | Placebo + Pioglitazone 15 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| OG003 |
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
|
| Placebo + Pioglitazone 15 |
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG004 | Alogliptin 12.5 + Pioglitazone 15 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG005 | Alogliptin 25 + Pioglitazone 15 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| OG006 | Placebo + Pioglitazone 30 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG007 | Alogliptin 12.5 + Pioglitazone 30 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG008 | Alogliptin 25 + Pioglitazone 30 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| OG009 | Placebo + Pioglitazone 45 | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG010 | Alogliptin 12.5 + Pioglitazone 45 | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| OG011 | Alogliptin 25 + Pioglitazone 45 | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
|
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