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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-8352 | Registry Identifier | WHO |
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The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.
Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system.
In response to this problem, Takeda Global Research & Development Center, Inc. is developing SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV 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.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin 6.25 mg QD | Experimental |
| |
| Alogliptin 12.5 mg QD | Experimental |
| |
| Alogliptin 25 mg QD | Experimental |
| |
| Alogliptin 50 mg QD | Experimental |
| |
| Alogliptin 100 mg QD | Experimental |
| |
| Placebo QD | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline. | Baseline and Day 85. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin at Day 43. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline. | Baseline and Day 43. |
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Inclusion Criteria:
Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:
Body mass index ≥23 kg/m2 and ≤40 kg/m2.
Fasting C-peptide concentration ≥0.8 ng/mL.
Glycosylated hemoglobin concentration between 6.8% and 11.0%.
Fasting plasma glucose >126 mg/dL at Screening.
No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following:
Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg.
Female subjects could neither be pregnant (confirmed by laboratory testing) nor lactating, and if of childbearing potential must have been practicing adequate contraception.
Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
No major illness or debility that in the investigator's opinion prohibited the subject from completing the study.
Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females.
Hepatic transaminase ≤2 x upper limit of normal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VP Biological Sciences | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19793357 | Result | Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30. |
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Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.
Participants enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD | Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. |
| FG001 | Alogliptin 6.25 mg QD | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks |
| FG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
| FG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
| FG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
| FG005 | Alogliptin 100 mg QD | Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. |
| BG001 | Alogliptin 6.25 mg QD | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 in Glycosylated Hemoglobin (HbA1c) at Day 85. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | percentage of Glycosylated Hemoglobin | Baseline and Day 85. |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QD | Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D006946 | Hyperinsulinism |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C520853 | alogliptin |
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| Alogliptin | Drug | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
| Alogliptin | Drug | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
| Alogliptin | Drug | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
| Alogliptin | Drug | Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
| Placebo | Drug | Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. |
|
| Change From Baseline in Fasting Plasma Glucose (Day 43). |
The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline. |
| Baseline and Day 43 |
| Change From Baseline in Fasting Plasma Glucose (Day 85). | The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline. | Baseline and Day 85. |
| Change From Baseline in Fasting Fructosamine (Day 43). | The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline. | Baseline and Day 43. |
| Change From Baseline in Fasting Fructosamine (Day 85). | The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline. | Baseline and Day 85. |
| Change From Baseline in Total Cholesterol (Day 43). | The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline. | Baseline and Day 43 |
| Change From Baseline in Total Cholesterol (Day 85). | The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline. | Baseline and Day 85. |
| Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline. | Baseline and Day 43. |
| Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline. | Baseline and Day 85. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline. | Baseline and Day 43. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline. | Baseline and Day 85. |
| Change From Baseline in Triglycerides (Day 43). | The change between triglycerides collected at day 43 and triglycerides collected at baseline. | Baseline and Day 43. |
| Change From Baseline in Triglycerides (Day 85). | The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline. | Baseline and Day 85. |
| Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population. | 85 Days. |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Hyperglycemic Rescue |
|
| Physician Decision |
|
| Administrative Error |
|
| Participant Non-compliance |
|
| BG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
| BG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
| BG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
| BG005 | Alogliptin 100 mg QD | Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks |
| OG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. |
| OG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. |
| OG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. |
| OG005 | Alogliptin 100 mg QD | Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin at Day 43. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | percentage of Glycosylated Hemoglobin | Baseline and Day 43. |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (Day 43). | The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 43 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (Day 85). | The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 85. |
|
|
|
|
| Secondary | Change From Baseline in Fasting Fructosamine (Day 43). | The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 43. |
|
|
|
|
| Secondary | Change From Baseline in Fasting Fructosamine (Day 85). | The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 85. |
|
|
|
|
| Secondary | Change From Baseline in Total Cholesterol (Day 43). | The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 43 |
|
|
|
|
| Secondary | Change From Baseline in Total Cholesterol (Day 85). | The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 85. |
|
|
|
|
| Secondary | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 43. |
|
|
|
|
| Secondary | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 85. |
|
|
|
|
| Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 43. |
|
|
|
|
| Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 85. |
|
|
|
|
| Secondary | Change From Baseline in Triglycerides (Day 43). | The change between triglycerides collected at day 43 and triglycerides collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 43. |
|
|
|
|
| Secondary | Change From Baseline in Triglycerides (Day 85). | The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline. | Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Day 85. |
|
|
|
|
| Secondary | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population. | Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline. Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics. | Posted | Mean | Standard Deviation | percent incidence | 85 Days. |
|
|
|
| 2 |
| 41 |
| 14 |
| 41 |
| EG001 | Alogliptin 6.25 mg QD | Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks | 1 | 42 | 12 | 42 |
| EG002 | Alogliptin 12.5 mg QD | Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. | 0 | 44 | 18 | 44 |
| EG003 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. | 1 | 45 | 19 | 45 |
| EG004 | Alogliptin 50 mg QD | Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. | 0 | 43 | 15 | 43 |
| EG005 | Alogliptin 100 mg QD | Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. | 0 | 44 | 22 | 44 |
| Noncardiac chest pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 7.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 7.1 | 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.
Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.017 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.32 | Standard Error of the Mean | 0.134 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.016 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.34 | Standard Error of the Mean | 0.138 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.005 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.38 | Standard Error of the Mean | 0.134 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.008 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.37 | Standard Error of the Mean | 0.137 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.321 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.14 | Standard Error of the Mean | 0.136 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates. | <0.001 | No multiplicity adjustments. | Mean Difference (Final Values) | -30.5 | Standard Error of the Mean | 8.40 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates. | 0.009 | No multiplicity adjustments. | Mean Difference (Final Values) | -22.8 | Standard Error of the Mean | 8.68 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates | <0.001 | No multiplicity adjustments. | Mean Difference (Final Values) | -29.4 | Standard Error of the Mean | 8.38 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates | 0.057 | No multiplicity adjustments. | Mean Difference (Final Values) | -16.4 | Standard Error of the Mean | 8.57 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates. | 0.156 | No multiplicity adjustments | Mean Difference (Final Values) | -12.2 | Standard Error of the Mean | 8.56 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates. | 0.001 | No multiplicity adjustments. | Mean Difference (Final Values) | -29.4 | Standard Error of the Mean | 8.91 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates. | 0.008 | No multiplicity adjustments. | Mean Difference (Final Values) | -24.6 | Standard Error of the Mean | 9.20 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates. | <0.001 | No multiplicity adjustments. | Mean Difference (Final Values) | -35.5 | Standard Error of the Mean | 8.88 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.136 | No multiplicity adjustments. | Mean Difference (Final Values) | -13.6 | Standard Error of the Mean | 9.09 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates. | 0.073 | No multiplicity adjustments. | Mean Difference (Final Values) | -16.3 | Standard Error of the Mean | 9.07 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.010 | No multiplicity adjustments. | Mean Difference (Final Values) | -19.2 | Standard Error of the Mean | 7.37 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.002 | No multiplicity adjustments. | Mean Difference (Final Values) | -23.8 | Standard Error of the Mean | 7.71 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.003 | No multiplicity adjustments. | Mean Difference (Final Values) | -22.1 | Standard Error of the Mean | 7.33 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.006 | No multiplicity adjustments. | Mean Difference (Final Values) | -20.7 | Standard Error of the Mean | 7.44 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.117 | No multiplicity adjustments. | Mean Difference (Final Values) | -11.7 | Standard Error of the Mean | 7.45 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.136 | No multiplicity adjustments. | Mean Difference (Final Values) | -12.5 | Standard Error of the Mean | 8.35 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.022 | No multiplicity adjustments. | Mean Difference (Final Values) | -20.1 | Standard Error of the Mean | 8.73 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.004 | No multiplicity adjustments. | Mean Difference (Final Values) | -24.1 | Standard Error of the Mean | 8.26 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.040 | No multiplicity adjustments. | Mean Difference (Final Values) | -17.5 | Standard Error of the Mean | 8.48 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates. | 0.378 | No multiplicity adjustments. | Mean Difference (Final Values) | -7.5 | Standard Error of the Mean | 8.47 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.346 | No multiplicity adjustments. | Mean Difference (Final Values) | 6.4 | Standard Error of the Mean | 6.80 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.901 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.9 | Standard Error of the Mean | 7.13 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.851 | No multiplicity adjustments. | Mean Difference (Final Values) | 1.3 | Standard Error of the Mean | 6.79 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.825 | No multiplicity adjustments. | Mean Difference (Final Values) | 1.5 | Standard Error of the Mean | 6.86 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.843 | No multiplicity adjustments. | Mean Difference (Final Values) | 1.4 | Standard Error of the Mean | 6.94 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.018 | No multiplicity adjustments. | Mean Difference (Final Values) | 14.6 | Standard Error of the Mean | 6.14 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.258 | No multiplicity adjustments. | Mean Difference (Final Values) | 7.3 | Standard Error of the Mean | 6.47 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.299 | No multiplicity adjustments. | Mean Difference (Final Values) | 6.4 | Standard Error of the Mean | 6.13 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.103 | No multiplicity adjustments. | Mean Difference (Final Values) | 10.3 | Standard Error of the Mean | 6.27 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates. | 0.340 | No multiplicity adjustments. | Mean Difference (Final Values) | 6.0 | Standard Error of the Mean | 6.32 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.742 | No multiplicity adjustments. | Mean Difference (Final Values) | 0.3 | Standard Error of the Mean | 1.05 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.220 | No multiplicity adjustments. | Mean Difference (Final Values) | -1.4 | Standard Error of the Mean | 1.11 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.348 | No multiplicity adjustments. | Mean Difference (Final Values) | -1.0 | Standard Error of the Mean | 1.05 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.627 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.5 | Standard Error of the Mean | 1.06 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.418 | No multiplicity adjustments. | Mean Difference (Final Values) | 0.9 | Standard Error of the Mean | 1.06 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.052 | No multiplicity adjustments. | Mean Difference (Final Values) | 2.3 | Standard Error of the Mean | 1.20 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.906 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 1.28 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.628 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.6 | Standard Error of the Mean | 1.19 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.749 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 1.22 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates. | 0.340 | No multiplicity adjustments. | Mean Difference (Final Values) | 1.2 | Standard Error of the Mean | 1.22 | 95 | Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.076 | No multiplicity adjustments. | Mean Difference (Final Values) | 9.7 | Standard Error of the Mean | 5.46 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.867 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.9 | Standard Error of the Mean | 5.66 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.169 | No multiplicity adjustments. | Mean Difference (Final Values) | 7.4 | Standard Error of the Mean | 5.40 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.645 | No multiplicity adjustments. | Mean Difference (Final Values) | 2.5 | Standard Error of the Mean | 5.45 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.351 | No multiplicity adjustments. | Mean Difference (Final Values) | 5.2 | Standard Error of the Mean | 5.51 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | <0.001 | No multiplicity adjustments. | Mean Difference (Final Values) | 17.6 | Standard Error of the Mean | 5.06 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.103 | No multiplicity adjustments. | Mean Difference (Final Values) | 8.6 | Standard Error of the Mean | 5.26 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.009 | No multiplicity adjustments. | Mean Difference (Final Values) | 13.0 | Standard Error of the Mean | 4.98 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates | 0.034 | No multiplicity adjustments. | Mean Difference (Final Values) | 11.0 | Standard Error of the Mean | 5.14 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates. | 0.033 | No multiplicity adjustments. | Mean Difference (Final Values) | 11.1 | Standard Error of the Mean | 5.16 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.557 | No multiplicity adjustments. | Mean Difference (Final Values) | -12.8 | Standard Error of the Mean | 21.85 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.616 | No multiplicity adjustments. | Mean Difference (Final Values) | 11.5 | Standard Error of the Mean | 22.85 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.679 | No multiplicity adjustments. | Mean Difference (Final Values) | -9.0 | Standard Error of the Mean | 21.73 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.697 | No multiplicity adjustments. | Mean Difference (Final Values) | 8.5 | Standard Error of the Mean | 21.94 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.672 | No multiplicity adjustments. | Mean Difference (Final Values) | -9.4 | Standard Error of the Mean | 22.03 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| No |
| Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.597 | No multiplicity adjustments. | Mean Difference (Final Values) | -11.0 | Standard Error of the Mean | 20.74 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.982 | No multiplicity adjustments. | Mean Difference (Final Values) | -0.5 | Standard Error of the Mean | 21.77 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.358 | No multiplicity adjustments. | Mean Difference (Final Values) | -19.0 | Standard Error of the Mean | 20.62 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.274 | No multiplicity adjustments. | Mean Difference (Final Values) | 23.1 | Standard Error of the Mean | 21.06 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |
| The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level. | ANCOVA | Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates. | 0.554 | No multiplicity adjustments. | Mean Difference (Final Values) | -12.5 | Standard Error of the Mean | 21.06 | 95 | Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm. | No | Superiority or Other |