Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00095030
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-10-29
• Study First Submitted QC: 2004-10-29
• Study First Posted: 2004-11-01
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2007-09
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Disposition First Posted: 2010-09-14
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1752

Inclusion Criteria

• Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
• HbA1c >or = 7% and < or = 10%
• Fasting c-peptide > or = 1.0 umol
• Body Mass Index < or = 41 kg/m2
• Mean serum triglycerides < or = 600 mg/dl

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in baseline HbA1c after 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks

Trial Locations

Locations (1)

Local Institution; 🇹🇭 Bangkok, Thailand