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Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: August 9, 2006
Last updated: April 15, 2010
Last verified: April 2010
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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • TG / HDL-C ratio [ Time Frame: 24 weeks ]

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

Enrollment: 482
Study Start Date: October 2006
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
Active Comparator: 2 Drug: Metformin
500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks


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

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.

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Please refer to this study by its identifier: NCT00362323

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Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Michel Conte Solvay Pharmaceuticals
  More Information Identifier: NCT00362323     History of Changes
Other Study ID Numbers: C LF23-0121 06 01
Study First Received: August 9, 2006
Last Updated: April 15, 2010

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on May 25, 2017