Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Verified by: Solvay Pharmaceuticals, April 2010
First Received: August 9, 2006 | Last Updated: April 15, 2010 | Phase: Phase 3 | Start Date: October 2006
Overall Status: Completed | Estimated Enrollment: 482
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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...

Brief Summary

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.”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

  • 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
  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • TG / HDL-C ratio
    • Time Frame: 24 weeks
      Safety Issue?: No

Secondary Measures

  • Lipid and glycemic parameters
    • Time Frame: 24 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Solvay Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Michel Conte Study Director Solvay Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362323

Study ID Number: C LF23-0121 06 01

ClinicalTrials.gov Identifier: NCT00362323

Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante

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