Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

April 15, 2010 updated by: Solvay Pharmaceuticals

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

482

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
        • C LF23-0121 06 01 Site107
      • Holesov, Czech Republic
        • C LF23-0121 06 01 Site108
      • Karlovy Vary, Czech Republic
        • C LF23-0121 06 01 Site101
      • Olomouc, Czech Republic
        • C LF23-0121 06 01 Site106
      • Olomouc, Czech Republic
        • C LF23-0121 06 01 Site109
      • Pardubice, Czech Republic
        • C LF23-0121 06 01 Site103
      • Praha, Czech Republic
        • C LF23-0121 06 01 Site102
      • Praha, Czech Republic
        • C LF23-0121 06 01 Site104
      • Praha, Czech Republic
        • C LF23-0121 06 01 Site105
  • France
      • Bailleul, France
        • C LF23-0121 06 01 Site 204
      • Bondy, France
        • C LF23-0121 06 01 Site 200
      • Cholet, France
        • C LF23-0121 06 01 Site 207
      • Evreux, France
        • C LF23-0121 06 01 Site 208
      • Pantin, France
        • C LF23-0121 06 01 Site 201
      • Tours, France
        • C LF23-0121 06 01 Site 202
      • Wattrelos, France
        • C LF23-0121 06 01 Site 205
  • Hungary
      • Balatonfüred, Hungary
        • C LF23-0121 06 01 Site 406
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 400
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 401
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 402
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 403
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 405
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 407
      • Budapest, Hungary
        • C LF23-0121 06 01 Site 408
      • Debrecen, Hungary
        • C LF23-0121 06 01 Site 404
  • India
      • Bangalore, India
        • C LF23-0121 06 01 Site 501
      • Bangalore, India
        • C LF23-0121 06 01 Site 504
      • Bangalore, India
        • C LF23-0121 06 01 Site 516
      • Bangalore, India
        • C LF23-0121 06 01 Site 519
      • Chennai, India
        • C LF23-0121 06 01 Site 508
      • Chennai, India
        • C LF23-0121 06 01 Site 510
      • Hyderabad, India
        • C LF23-0121 06 01 Site 505
      • Hyderabad, India
        • C LF23-0121 06 01 Site 509
      • Hyderabad, India
        • C LF23-0121 06 01 Site 517
      • Karnataka, India
        • C LF23-0121 06 01 Site 511
      • Maharashtra, India
        • C LF23-0121 06 01 Site 512
      • Mumbai, India
        • C LF23-0121 06 01 Site 502
      • Mumbai, India
        • C LF23-0121 06 01 Site 503
      • Nasik, India
        • C LF23-0121 06 01 Site 518
      • Pune, India
        • C LF23-0121 06 01 Site 506
      • Tiruvanathapuram-Kerala, India
        • C LF23-0121 06 01 Site 514
  • Lithuania
      • Vilnius, Lithuania
        • C LF23-0121 06 01 Site 800
      • Vilnius, Lithuania
        • C LF23-0121 06 01 Site 801
      • Vilnius, Lithuania
        • C LF23-0121 06 01 Site 802
  • Poland
      • Bialystok, Poland
        • C LF23-0121 06 01 Site 600
      • Bydgoszcz, Poland
        • C LF23-0121 06 01 Site 613
      • Grudziadz, Poland
        • C LF23-0121 06 01 Site 618
      • Katowice, Poland
        • C LF23-0121 06 01 Site 603
      • Kraków, Poland
        • C LF23-0121 06 01 Site 601
      • Kraków, Poland
        • C LF23-0121 06 01 Site 607
      • Kraków, Poland
        • C LF23-0121 06 01 Site 610
      • Kutno, Poland
        • C LF23-0121 06 01 Site 615
      • Olsztyn, Poland
        • C LF23-0121 06 01 Site 605
      • Opole, Poland
        • C LF23-0121 06 01 Site 604
      • Poznan, Poland
        • C LF23-0121 06 01 Site 606
      • Poznan, Poland
        • C LF23-0121 06 01 Site 609
      • Sliwinska, Poland
        • C LF23-0121 06 01 Site 621
      • Starogard Gdanski, Poland
        • C LF23-0121 06 01 Site 617
      • Szczecin, Poland
        • C LF23-0121 06 01 Site 616
      • Warszawa, Poland
        • C LF23-0121 06 01 Site 602
      • Warszawa, Poland
        • C LF23-0121 06 01 Site 608
      • Warszawa, Poland
        • C LF23-0121 06 01 Site 619
      • Warszawa, Poland
        • C LF23-0121 06 01 Site 620
      • Wroclaw, Poland
        • C LF23-0121 06 01 Site 611
      • Wroclaw, Poland
        • C LF23-0121 06 01 Site 612
      • Zgierz, Poland
        • C LF23-0121 06 01 Site 614
  • Slovakia
      • Bratislava, Slovakia
        • C LF23-0121 06 01 Site 700
      • Kosice, Slovakia
        • C LF23-0121 06 01 Site 703
      • Lucenec, Slovakia
        • C LF23-0121 06 01 Site 702
      • Skalica, Slovakia
        • C LF23-0121 06 01 Site 701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TG / HDL-C ratio
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipid and glycemic parameters
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Investigators

  • Study Director: Michel Conte, Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 9, 2006

First Submitted That Met QC Criteria

August 9, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2010

Last Update Submitted That Met QC Criteria

April 15, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C LF23-0121 06 01
  • 2006-000924-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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