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Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362323
First Posted: August 10, 2006
Last Update Posted: April 16, 2010
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.
Information provided by:
Solvay Pharmaceuticals
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00362323


  Show 70 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Michel Conte Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00362323     History of Changes
Other Study ID Numbers: C LF23-0121 06 01
2006-000924-15
First Submitted: August 9, 2006
First Posted: August 10, 2006
Last Update Posted: April 16, 2010
Last Verified: April 2010

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

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