Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Condition(s) targeted: Dyslipidemia; Glucose Metabolism Disorders

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

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Solvay Pharmaceuticals

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

To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C

Official title: A Randomized, Double-Blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.

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

Primary outcome: TG / HDL-C ratio

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 treated with stable dose of metformin and with

dyslipidemia not appropriately controlled with a statin treatment.

Exclusion Criteria:

- Type 1 diabetes.

Site101, Karlovy Vary, Czech Republic

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Starting date: August 2006
Ending date: March 2009
Last updated: May 20, 2008