A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

Phase 3

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00240370
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-03
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Status Verified: 2008-06
• 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: 1159

Inclusion Criteria

• Type 2 diabetics
• HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
• Fasting C-peptide ≥1.0 ng/mL
• BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL

Exclusion Criteria

• symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study
• history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
• History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin

Secondary Outcome Measures

Name	Time	Method
Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in
hs-CRP from baseline to W24

Trial Locations

Locations (1)

Local Institution; 🇵🇷 Ponce, Puerto Rico