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Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

This study has been terminated.
(The study was discontinued prematurely at the end of March 2007 due to slow enrolment.)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00361868
First received: August 8, 2006
Last updated: June 26, 2008
Last verified: June 2008
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • HbA1c/TG [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid and glycemic parameters. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 diabetes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361868

  Show 70 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Michel Conte, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00361868     History of Changes
Other Study ID Numbers: C LF23-0121 05 01, 2005-006060-63
Study First Received: August 8, 2006
Last Updated: June 26, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Solvay Pharmaceuticals:
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Dyslipidemias
Glucose Metabolism Disorders
Endocrine System Diseases
Lipid Metabolism Disorders
Rosiglitazone
Metformin
 Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013