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

August 9, 2006
April 15, 2010
October 2006
August 2008   (final data collection date for primary outcome measure)
TG / HDL-C ratio [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
TG/HDL after 24 weeks treatment
Complete list of historical versions of study NCT00362323 on ClinicalTrials.gov Archive Site
Lipid and glycemic parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Lipid and glycemic parameters
Not Provided
Not Provided
 
Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dyslipidemia/Glucose Metabolism Disorder
  • 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
  • Experimental: 1
    Intervention: Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
  • Active Comparator: 2
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
482
March 2009
August 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Hungary,   India,   Poland,   Slovakia,   Lithuania,   Czech Republic
 
NCT00362323
C LF23-0121 06 01, 2006-000924-15
No
Not Provided
Solvay Pharmaceuticals
Not Provided
Study Director: Michel Conte Solvay Pharmaceuticals
Solvay Pharmaceuticals
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP