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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MP-513 Medium Dose and Metformin; Drug: MP-513 Low Dose and Metformin; Drug: MP-513 Lowest Dose and Metformin; Drug: Placebo and Metformin; Drug: MP-513 High Dose and Metformin

• Registration Number: NCT00971243
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2014-08
• Results First Submitted: 2014-08-21
• Results First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Results First Posted: 2014-09-01
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

• Patients who are aged ≧ 18 years old.
• Patients whose HbA1c is ≧ 7.0 % and < 10.0%.
• Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
• Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

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Exclusion Criteria

• Patients with type 1 diabetes or secondary form of diabetes.
• Patients with heart failure symptoms.
• Patients with serious diabetic complications.
• Patients with severe hepatic disorder or severe renal disorder.
• Patients who are the excessive alcohol addicts.
• Patients who are 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
MP-513 Medium Dose and Metformin	MP-513 Medium Dose and Metformin	-
MP-513 Low Dose and Metformin	MP-513 Low Dose and Metformin	-
MP-513 Lowest Dose and Metformin	MP-513 Lowest Dose and Metformin	-
Placebo and Metformin	Placebo and Metformin	-
MP-513 High Dose and Metformin	MP-513 High Dose and Metformin	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Week 24	Baseline and Week 24	The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24	Baseline and Week 24	Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.
Adverse Events, Laboratory Tests, Vital Signs, Etc.	Weeks 24, 52