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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Teneli / Teneli + SU; Drug: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)

• Registration Number: NCT00974090
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-04
• Results First Submitted: 2014-04-07
• Results First Submitted QC: 2014-04-07
• Last Update Submitted: 2014-04-07
• Results First Posted: 2014-05-08
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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 between 7.0% and 10.0%
• Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Read More

Exclusion Criteria

• Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
• Patients with Class III/IV heart failure symptoms according to NYHA functional classification
• Patients who are gastrointestinal disorder (diarrhea, vomiting)
• Patients with serious diabetic complications
• Patients who are the excessive alcohol addicts
• Patients with severe hepatic disorder or severe renal disorder
• Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teneli / Teneli + SU	Teneli / Teneli + SU	-
Placebo / Teneli + SU	Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at Week 12	at Week 0 and Week 12	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	at Week 0 and Week 12	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 the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12	0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12	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.
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12	at Week 0 and Week 12	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.