Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Condition(s) targeted: Dyslipidemia; Glucose Metabolism Disorder

Intervention: fenofibrate (F) + metformin (M) hydrochloride fixed combination (Drug); Rosiglitazone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: HbA1c/TG

Secondary outcome: Lipid and glycemic parameters.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with

lifestyle modifications.

Exclusion Criteria:

- Type 1 diabetes.

Site100, Zagreb, Croatia

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Starting date: June 2006
Ending date: December 2007
Last updated: December 20, 2007