NCT00361868

Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemia
• Glucose Metabolism Disorder

Interventions

Type	Name	Description
DRUG	fenofibrate (F) + metformin (M) hydrochloride fixed combination	First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
DRUG	Rosiglitazone	First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-08-09
• Last updated: 2008-06-27

Locations

70 sites across 8 countries: Croatia, Finland, France, Germany, Netherlands, Poland, Romania, Ukraine