PPAR - Combination With Metformin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Muraglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162240

CV168-022

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind