Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
Overview[ - collapse ][ - ]
Purpose | The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Alogliptin and metformin Drug: Alogliptin and metformin Drug: Metformin |
Phase | Phase 2/Phase 3 |
Sponsor | Takeda |
Responsible Party | Takeda |
ClinicalTrials.gov Identifier | NCT01318109 |
First Received | March 16, 2011 |
Last Updated | February 1, 2012 |
Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 16, 2011 |
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Last Updated Date | February 1, 2012 |
Start Date | August 2008 |
Estimated Primary Completion Date | April 2009 |
Current Primary 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 or final visit and glycosylated hemoglobin collected at baseline. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan |
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Official Title | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin in Subjects With Type 2 Diabetes in Japan |
Brief Summary | The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose. |
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. The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies. |
Study Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Alogliptin and metformin Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. Other Names:
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. Other Names:
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks. Other Names: Glycoran |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 288 |
Estimated Completion Date | April 2009 |
Estimated Primary Completion Date | April 2009 |
Eligibility Criteria | Inclusion Criteria: 1. Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0). 2. Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4). 3. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place). 4. Was receiving specific diet and exercise (if any) therapies during the observation period. Exclusion Criteria: 1. Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0). 2. With a history or symptoms of lactic acidosis. |
Gender | Both |
Ages | 26 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01318109 |
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Other Study ID Numbers | SYR-322/CCT-006 |
Has Data Monitoring Committee | No |
Information Provided By | Takeda |
Study Sponsor | Takeda |
Collaborators | Not Provided |
Investigators | Study Director: Professor, Diabetes and Endocrine Division Department of Medicine, Kawasaki Medical School |
Verification Date | February 2012 |