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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-3992 | Registry Identifier | WHO |
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The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
"To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | Experimental |
| |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin and voglibose | Drug | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events. | A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below. | 52 Weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | 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 week 8 and glycosylated hemoglobin collected at baseline. | Baseline and Week 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor, Department of Medicine | Kawasaki Medical School | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22106975 | Derived | Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011 Nov;27 Suppl 3:21-9. doi: 10.1185/03007995.2011.614936. |
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Participants enrolled in one of 2, once-daily (QD) or three-times daily (TID) treatment groups. Analyses performed by treatment group or treatment dose in this study. All 213 participants randomized in the phase 2/3 α-glucosidase inhibitor (NCT01263483) study are included in the Full Analysis Set in this study, of which 179 randomized.
Participants enrolled at 24 investigative sites in Japan from 06 June 2007 to 02 October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 12.5 mg Combination Dose Group* → 12.5 mg Combination Group | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study. |
| FG001 | 25 mg Combination Dose Group* → 25 mg Combination Dose Group | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study. |
| FG002 | α-glucosidase Monotherapy Group* → 12.5 mg Combination Group | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study. |
| FG003 | α-glucosidase Monotherapy Group*→ 25 mg Combination Group | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled - Long-Term Extension Study |
| |||||||||||||
| Entered - Long-Term Extension Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
| BG001 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID |
| 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 | Number of Participants With Adverse Events. | A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below. | Adverse Event Profile in the Safety Analysis Set | Posted | Number | participants | 52 Weeks. |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and the last dose of study 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 | Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager | Japan Development Center, Pharmaceutical Development Division | +81-6-6204-5257 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| 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 |
| C102817 | voglibose |
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|
| Alogliptin and voglibose | Drug | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
|
|
| Change From Baseline in Glycosylated Hemoglobin (Week 12). |
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 week 12 and glycosylated hemoglobin collected at baseline. |
| Baseline and Week 12. |
| Change From Baseline in Glycosylated Hemoglobin (Week 16). | 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 week 16 and glycosylated hemoglobin collected at baseline. | Baseline and Week 16. |
| Change From Baseline in Glycosylated Hemoglobin (Week 20). | 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 week 20 and glycosylated hemoglobin collected at baseline. | Baseline and Week 20. |
| Change From Baseline in Glycosylated Hemoglobin (Week 24). | 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 week 24 and glycosylated hemoglobin collected at baseline. | Baseline and Week 24. |
| Change From Baseline in Glycosylated Hemoglobin (Week 28). | 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 week 28 and glycosylated hemoglobin collected at baseline. | Baseline and Week 28. |
| Change From Baseline in Glycosylated Hemoglobin (Week 32). | 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 week 32 and glycosylated hemoglobin collected at baseline. | Baseline and Week 32. |
| Change From Baseline in Glycosylated Hemoglobin (Week 36). | 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 week 36 and glycosylated hemoglobin collected at baseline. | Baseline and Week 36. |
| Change From Baseline in Glycosylated Hemoglobin (Week 40). | 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 week 40 and glycosylated hemoglobin collected at baseline. | Baseline and Week 40. |
| Change From Baseline in Glycosylated Hemoglobin (Week 44). | 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 week 44 and glycosylated hemoglobin collected at baseline. | Baseline and Week 44. |
| Change From Baseline in Glycosylated Hemoglobin (Week 48). | 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 week 48 and glycosylated hemoglobin collected at baseline. | Baseline and Week 48. |
| Change From Baseline in Glycosylated Hemoglobin (Week 52). | 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 week 52 and glycosylated hemoglobin collected at baseline. | Baseline and Week 52. |
| Change From Baseline in Glycosylated Hemoglobin (Final Visit). | 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 week 52 or final visit and glycosylated hemoglobin collected at baseline. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Fasting Plasma Glucose (Week 8). | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. | Baseline and Week 8. |
| Change From Baseline in Fasting Plasma Glucose (Week 12). | The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. | Baseline and Week 12. |
| Change From Baseline in Fasting Plasma Glucose (Week 16). | The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. | Baseline and Week 16. |
| Change From Baseline in Fasting Plasma Glucose (Week 20). | The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. | Baseline and Week 20. |
| Change From Baseline in Fasting Plasma Glucose (Week 24). | The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline. | Baseline and Week 24. |
| Change From Baseline in Fasting Plasma Glucose (Week 28). | The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline. | Baseline and Week 28. |
| Change From Baseline in Fasting Plasma Glucose (Week 32). | The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline. | Baseline and Week 32. |
| Change From Baseline in Fasting Plasma Glucose (Week 36). | The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline. | Baseline and Week 36. |
| Change From Baseline in Fasting Plasma Glucose (Week 40). | The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline. | Baseline and Week 40. |
| Change From Baseline in Fasting Plasma Glucose (Week 44). | The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline. | Baseline and Week 44. |
| Change From Baseline in Fasting Plasma Glucose (Week 48). | The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline. | Baseline and Week 48. |
| Change From Baseline in Fasting Plasma Glucose (Week 52). | The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline. | Baseline and Week 52. |
| Change From Baseline in Fasting Plasma Glucose (Final Visit). | The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Fasting C-peptide (Week 8). | The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline. | Baseline and Week 8. |
| Change From Baseline in Fasting C-peptide (Week 12). | The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline. | Baseline and Week 12. |
| Change From Baseline in Fasting C-peptide (Week 16). | The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline. | Baseline and Week 16. |
| Change From Baseline in Fasting C-peptide (Week 20). | The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline. | Baseline and Week 20. |
| Change From Baseline in Fasting C-peptide (Week 24). | The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline. | Baseline and Week 24. |
| Change From Baseline in Fasting C-peptide (Week 28). | The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline. | Baseline and Week 28. |
| Change From Baseline in Fasting C-peptide (Week 32). | The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline. | Baseline and Week 32. |
| Change From Baseline in Fasting C-peptide (Week 36). | The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline. | Baseline and Week 36. |
| Change From Baseline in Fasting C-peptide (Week 40). | The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline. | Baseline and Week 40. |
| Change From Baseline in Fasting C-peptide (Week 44). | The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline. | Baseline and Week 44. |
| Change From Baseline in Fasting C-peptide (Week 48). | The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline. | Baseline and Week 48. |
| Change From Baseline in Fasting C-peptide (Week 52). | The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline. | Baseline and Week 52. |
| Change From Baseline in Fasting C-peptide (Final Visit). | The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 24. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 52. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 24. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 52. |
| Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 24. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 52. |
| Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 24. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 52. |
| Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Final Visit (up to Week 52). |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 12. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 24. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Week 52. |
| Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Baseline and Final Visit (up to Week 52). |
| COMPLETED |
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| NOT COMPLETED |
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Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 8). | 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 week 8 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 8. |
|
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|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 12). | 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 week 12 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 12. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 16). | 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 week 16 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 16. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 20). | 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 week 20 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 20. |
|
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|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 24). | 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 week 24 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 24. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 28). | 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 week 28 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 28. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 32). | 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 week 32 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 32. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 36). | 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 week 36 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 36. |
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 40). | 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 week 40 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 40. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 44). | 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 week 44 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 44. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 48). | 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 week 48 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 48. |
|
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 52). | 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 week 52 and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Week 52. |
|
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|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | 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 week 52 or final visit and glycosylated hemoglobin collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline and Final Visit (up to Week 52). |
|
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 8). | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 8. |
|
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 12). | The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 16). | The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 16. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 20). | The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 20. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 24). | The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 28). | The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 28. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 32). | The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 32. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 36). | The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 36. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 40). | The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 40. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 44). | The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 44. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 48). | The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 52). | The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (Final Visit). | The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Final Visit (up to Week 52). |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 8). | The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 8. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 12). | The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 12. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 16). | The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 16. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 20). | The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 20. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 24). | The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 24. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 28). | The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 28. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 32). | The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 32. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 36). | The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 36. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 40). | The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 40. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 44). | The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 44. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 48). | The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 48. |
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| Secondary | Change From Baseline in Fasting C-peptide (Week 52). | The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 52. |
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| Secondary | Change From Baseline in Fasting C-peptide (Final Visit). | The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Final Visit (up to Week 52). |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). | The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12. |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). | The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24. |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). | The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52. |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). | The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Final Visit (up to Week 52). |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg•hr/dL | Baseline and Week 12. |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg•hr/dL | Baseline and Week 24. |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg•hr/dL | Baseline and Week 52. |
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| Secondary | Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | mg•hr/dL | Baseline and Final Visit (up to Week 52). |
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| Secondary | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | μU•hr/mL | Baseline and Week 12. |
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| Secondary | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | μU•hr/mL | Baseline and Week 24. |
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| Secondary | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | μU•hr/mL | Baseline and Week 52. |
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| Secondary | Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | μU•hr/mL | Baseline and Final Visit (up to Week 52). |
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| Secondary | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). | The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng•hr/mL | Baseline and Week 12. |
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| Secondary | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). | The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng•hr/mL | Baseline and Week 24. |
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| Secondary | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). | The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng•hr/mL | Baseline and Week 52. |
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| Secondary | Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). | The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | ng•hr/mL | Baseline and Final Visit (up to Week 52). |
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| Secondary | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). | The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | pg•hr/mL | Baseline and Week 12. |
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| Secondary | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). | The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | pg•hr/mL | Baseline and Week 24. |
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| Secondary | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). | The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | pg•hr/mL | Baseline and Week 52. |
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| Secondary | Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). | The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. | Values are Summary Statistics. | Posted | Mean | Standard Deviation | pg•hr/mL | Baseline and Final Visit (up to Week 52). |
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|
| 6 |
| 108 |
| 85 |
| 108 |
| EG001 | Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. | 7 | 105 | 73 | 105 |
| Pyelonephritis acute | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.