Text Size

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362323
First received: August 9, 2006
Last updated: April 15, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • TG / HDL-C ratio [ 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 ]

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

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 treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.

Exclusion Criteria Type 1 diabetes.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362323

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

No publications provided

ClinicalTrials.gov Identifier: NCT00362323     History of Changes
Other Study ID Numbers: C LF23-0121 06 01, 2006-000924-15
Study First Received: August 9, 2006
Last Updated: April 15, 2010
Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
India: Drugs Controller General of India
Lithuania: SMCA State Medicines Control Agency

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
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 June 18, 2013