PPAR - Combination With Metformin

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Metformin

Criteria

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