Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Teneligliptin 40 mg; Drug: Teneligliptin 10mg; Drug: Teneligliptin 20 mg; Drug: Placebo

• Registration Number: NCT00628212
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-24
• Study First Submitted QC: 2008-02-24
• Study First Posted: 2008-03-04
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2013-04
• Results First Submitted: 2013-04-12
• Results First Submitted QC: 2013-04-12
• Last Update Submitted: 2013-04-12
• Results First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Patients who are 20 - 75 years old
• Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
• Patients whose HbA1c is 6.5 - 9.5%
• Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

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Exclusion Criteria

• Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
• Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
• Patients with serious diabetic complications
• Patients who are habitual excessive alcohol consumption.
• Patients with severe hepatic disorder or severe renal disorder.
• Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teneligliptin 40 mg	Teneligliptin 40 mg	Teneligliptin 40 mg, orally, once daily
Teneligliptin 10 mg	Teneligliptin 10mg	Teneligliptin 10 mg, orally, once daily
Teneligliptin 20 mg	Teneligliptin 20 mg	Teneligliptin 20 mg, orally, once daily
Placebo	Placebo	Teneligliptin placebo-matching tablets, orally, once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at Week 12	12 weeks	The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose at Week 12	12 weeks	The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12	12 weeks	The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12	12 weeks	The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.