Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00361868

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 III

MedlinePlus related topics: Diabetes Metabolic Disorders

Drug Information available for: Metformin Metformin hydrochloride Procetofen Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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

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
1: Experimental	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
2: Active Comparator	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

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

Keywords provided by Solvay Pharmaceuticals:

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Procetofen
Rosiglitazone
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009