Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
This study has been completed.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01263496
First received: December 17, 2010
Last updated: February 1, 2012
Last verified: February 2012
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Purpose
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Alogliptin Drug: Voglibose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan. |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Number of Participants With Adverse Events. [ Time Frame: 52 Weeks. ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Change From Baseline in Glycosylated Hemoglobin (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 16). [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 20). [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 28). [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 32). [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 36). [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 40). [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 44). [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 48). [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glycosylated Hemoglobin (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]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.
- Change From Baseline in Fasting Plasma Glucose (Week 12). [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 16). [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 20). [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 28). [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 32). [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 36). [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 40). [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 44). [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 48). [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting Plasma Glucose (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 16). [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 20). [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 28). [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 32). [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 36). [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 40). [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 44). [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 48). [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
- Change From Baseline in Fasting C-peptide (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]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.
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]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.
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]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.
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]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.
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]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.
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]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.
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]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.
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ] [ Designated as safety issue: No ]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.
| Enrollment: | 438 |
| Study Start Date: | May 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Alogliptin 6.25 mg QD |
Drug: Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
Other Name: SYR-322
|
| Experimental: Alogliptin 12.5 mg QD |
Drug: Alogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
Other Name: SYR-322
|
| Experimental: Alogliptin 25 mg QD |
Drug: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
Other Name: SYR-322
|
| Experimental: Alogliptin 50 mg QD |
Drug: Alogliptin
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
Other Name: SYR-322
|
| Active Comparator: Voglibose 0.2-mg TID |
Drug: Voglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other Names:
|
Detailed Description:
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, 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 had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).
Eligibility| Ages Eligible for Study: | 29 Years to 87 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion Criteria:
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited ) |
| ClinicalTrials.gov Identifier: | NCT01263496 History of Changes |
| Other Study ID Numbers: | SYR-322/OCT-001, U1111-1118-4027 |
| Study First Received: | December 17, 2010 |
| Results First Received: | June 8, 2011 |
| Last Updated: | February 1, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Voglibose Alogliptin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013