PPAR - Combination With Metformin
Phase 3
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00162240
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 534
Inclusion Criteria
- Type 2 Diabetes
- HbA1c > - 7.0% and < - 10.0 %
- Mean serum triglyceride < - 600 mg/dL
- Body mass index < - 41 kg/m2
- Fasting c-peptide > - 1.0 ng/mL
Exclusion Criteria
- History of myocardial infarction (MI)
- 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 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 baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + 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
🇬🇧Swan Lake, United Kingdom