Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

June 26, 2008 updated by: Solvay Pharmaceuticals

A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia

Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

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

  • Croatia
      • Pula, Croatia
        • Site105
      • Rijeka, Croatia
        • Site102
      • Split, Croatia
        • Site103
      • Varazdin, Croatia
        • Site104
      • Zagreb, Croatia
        • Site100
      • Zagreb, Croatia
        • Site101
  • Finland
      • Jyväskylä, Finland
        • Site 205
      • Kokkola, Finland
        • Site 206
      • Laukaa, Finland
        • Site 208
      • Oulu, Finland
        • Site 207
  • France
      • Bassens, France
        • Site 303
      • Bordeaux, France
        • Site 307
      • Murs Erigne, France
        • Site 305
      • Seysses, France
        • Site 302
      • Strasbourg, France
        • Site 304
      • Thouars, France
        • Site 301
      • Vihiers, France
        • Site 306
  • Germany
      • Berlin, Germany
        • Site 405
      • Borna, Germany
        • Site 410
      • Bretten, Germany
        • Site 403
      • Dresden, Germany
        • Site 402
      • Frankfurt, Germany
        • Site 404
      • Freiburg, Germany
        • Site 400
      • Hannover, Germany
        • Site 401
      • Ilvesheim, Germany
        • Site 409
      • Ilvesheim, Germany
        • Site 411
      • Leipzig, Germany
        • Site 407
      • Rodgau, Germany
        • Site 406
      • Rotenburg, Germany
        • Site 413
      • Schwerin, Germany
        • Site 408
      • Villingen-Schwenningen, Germany
        • Site 412
  • Netherlands
      • Almere, Netherlands
        • Site 509
      • Breda, Netherlands
        • Site 502
      • Eindhoven, Netherlands
        • Site 503
      • Groningen, Netherlands
        • Site 504
      • Leiden, Netherlands
        • Site 505
      • Nijmegen, Netherlands
        • Site 506
      • Rotterdam, Netherlands
        • Site 500
      • Velp, Netherlands
        • Site 507
      • Zoetermeer, Netherlands
        • Site 508
  • Poland
      • Bialystok, Poland
        • Site 610
      • Elblag, Poland
        • Site 606
      • Gdansk, Poland
        • Site 608
      • Lodz, Poland
        • Site 600
      • Otolinska, Poland
        • Site 605
      • Radom, Poland
        • Site 604
      • Starogard Gdanski, Poland
        • Site 613
      • Warszawa, Poland
        • Site 601
      • Warszawa, Poland
        • Site 607
      • Warszawa, Poland
        • Site 612
      • Wroclaw, Poland
        • Site 602
      • Wroclaw, Poland
        • Site 603
  • Romania
      • Brasov, Romania
        • Site 704
      • Bucharest, Romania
        • Site 701
      • Bucharest, Romania
        • Site 703
      • Cluj-Napoca, Romania
        • Site 700
      • Iasi, Romania
        • Site 702
      • Targu-Mures, Romania
        • Site 705
  • Ukraine
      • Kharkiv, Ukraine
        • Site 807
      • Kharkiv, Ukraine
        • Site 811
      • Kharkiv, Ukraine
        • Site 812
      • Kiev, Ukraine
        • Site 800
      • Kiev, Ukraine
        • Site 803
      • Kiev, Ukraine
        • Site 808
      • Kiev, Ukraine
        • Site 809
      • Kiev, Ukraine
        • Site 810
      • Kiev, Ukraine
        • Site 813
      • Lviv, Ukraine
        • Site 805
      • Odessa, Ukraine
        • Site 804
      • Vinnitsa, Ukraine
        • Site 802

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 mellitus and dyslipidemia inadequately controlled with lifestyle modifications.

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
First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
Active Comparator: 2
Drug: Rosiglitazone
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c/TG
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

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

June 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 9, 2006

Study Record Updates

Last Update Posted (Estimate)

June 27, 2008

Last Update Submitted That Met QC Criteria

June 26, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C LF23-0121 05 01
  • 2005-006060-63

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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