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Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361868
Recruitment Status : Terminated (The study was discontinued prematurely at the end of March 2007 due to slow enrolment.)
First Posted : August 9, 2006
Last Update Posted : June 27, 2008
Information provided by:
Solvay Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Glucose Metabolism Disorder Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination Drug: Rosiglitazone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 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

Active Comparator: 2 Drug: Rosiglitazone
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks

Primary Outcome Measures :
  1. HbA1c/TG [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Lipid and glycemic parameters. [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361868

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Sponsors and Collaborators
Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
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Responsible Party: Michel Conte, Solvay Pharmaceuticals Identifier: NCT00361868    
Other Study ID Numbers: C LF23-0121 05 01
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: June 27, 2008
Last Verified: June 2008
Keywords provided by Solvay Pharmaceuticals:
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents