Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.

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

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Fenofibrate; Metformin; Rosiglitazone

Criteria

Inclusion Criteria:

• Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.

Exclusion Criteria:

• Type 1 diabetes.