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Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Primary Purpose

Dyslipidemia, Glucose Metabolism Disorder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fenofibrate (F) + metformin (M) hydrochloride fixed combination
Rosiglitazone
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications. Exclusion Criteria: Type 1 diabetes.

Sites / Locations

  • Site105
  • Site102
  • Site103
  • Site104
  • Site100
  • Site101
  • Site 205
  • Site 206
  • Site 208
  • Site 207
  • Site 303
  • Site 307
  • Site 305
  • Site 302
  • Site 304
  • Site 301
  • Site 306
  • Site 405
  • Site 410
  • Site 403
  • Site 402
  • Site 404
  • Site 400
  • Site 401
  • Site 409
  • Site 411
  • Site 407
  • Site 406
  • Site 413
  • Site 408
  • Site 412
  • Site 509
  • Site 502
  • Site 503
  • Site 504
  • Site 505
  • Site 506
  • Site 500
  • Site 507
  • Site 508
  • Site 610
  • Site 606
  • Site 608
  • Site 600
  • Site 605
  • Site 604
  • Site 613
  • Site 601
  • Site 607
  • Site 612
  • Site 602
  • Site 603
  • Site 704
  • Site 701
  • Site 703
  • Site 700
  • Site 702
  • Site 705
  • Site 807
  • Site 811
  • Site 812
  • Site 800
  • Site 803
  • Site 808
  • Site 809
  • Site 810
  • Site 813
  • Site 805
  • Site 804
  • Site 802

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

HbA1c/TG

Secondary Outcome Measures

Lipid and glycemic parameters.

Full Information

First Posted
August 8, 2006
Last Updated
June 26, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00361868
Brief Title
Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued prematurely at the end of March 2007 due to slow enrolment.
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Glucose Metabolism Disorder
Keywords
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fenofibrate (F) + metformin (M) hydrochloride fixed combination
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
Primary Outcome Measure Information:
Title
HbA1c/TG
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Lipid and glycemic parameters.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications. Exclusion Criteria: Type 1 diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site105
City
Pula
Country
Croatia
Facility Name
Site102
City
Rijeka
Country
Croatia
Facility Name
Site103
City
Split
Country
Croatia
Facility Name
Site104
City
Varazdin
Country
Croatia
Facility Name
Site100
City
Zagreb
Country
Croatia
Facility Name
Site101
City
Zagreb
Country
Croatia
Facility Name
Site 205
City
Jyväskylä
Country
Finland
Facility Name
Site 206
City
Kokkola
Country
Finland
Facility Name
Site 208
City
Laukaa
Country
Finland
Facility Name
Site 207
City
Oulu
Country
Finland
Facility Name
Site 303
City
Bassens
Country
France
Facility Name
Site 307
City
Bordeaux
Country
France
Facility Name
Site 305
City
Murs Erigne
Country
France
Facility Name
Site 302
City
Seysses
Country
France
Facility Name
Site 304
City
Strasbourg
Country
France
Facility Name
Site 301
City
Thouars
Country
France
Facility Name
Site 306
City
Vihiers
Country
France
Facility Name
Site 405
City
Berlin
Country
Germany
Facility Name
Site 410
City
Borna
Country
Germany
Facility Name
Site 403
City
Bretten
Country
Germany
Facility Name
Site 402
City
Dresden
Country
Germany
Facility Name
Site 404
City
Frankfurt
Country
Germany
Facility Name
Site 400
City
Freiburg
Country
Germany
Facility Name
Site 401
City
Hannover
Country
Germany
Facility Name
Site 409
City
Ilvesheim
Country
Germany
Facility Name
Site 411
City
Ilvesheim
Country
Germany
Facility Name
Site 407
City
Leipzig
Country
Germany
Facility Name
Site 406
City
Rodgau
Country
Germany
Facility Name
Site 413
City
Rotenburg
Country
Germany
Facility Name
Site 408
City
Schwerin
Country
Germany
Facility Name
Site 412
City
Villingen-Schwenningen
Country
Germany
Facility Name
Site 509
City
Almere
Country
Netherlands
Facility Name
Site 502
City
Breda
Country
Netherlands
Facility Name
Site 503
City
Eindhoven
Country
Netherlands
Facility Name
Site 504
City
Groningen
Country
Netherlands
Facility Name
Site 505
City
Leiden
Country
Netherlands
Facility Name
Site 506
City
Nijmegen
Country
Netherlands
Facility Name
Site 500
City
Rotterdam
Country
Netherlands
Facility Name
Site 507
City
Velp
Country
Netherlands
Facility Name
Site 508
City
Zoetermeer
Country
Netherlands
Facility Name
Site 610
City
Bialystok
Country
Poland
Facility Name
Site 606
City
Elblag
Country
Poland
Facility Name
Site 608
City
Gdansk
Country
Poland
Facility Name
Site 600
City
Lodz
Country
Poland
Facility Name
Site 605
City
Otolinska
Country
Poland
Facility Name
Site 604
City
Radom
Country
Poland
Facility Name
Site 613
City
Starogard Gdanski
Country
Poland
Facility Name
Site 601
City
Warszawa
Country
Poland
Facility Name
Site 607
City
Warszawa
Country
Poland
Facility Name
Site 612
City
Warszawa
Country
Poland
Facility Name
Site 602
City
Wroclaw
Country
Poland
Facility Name
Site 603
City
Wroclaw
Country
Poland
Facility Name
Site 704
City
Brasov
Country
Romania
Facility Name
Site 701
City
Bucharest
Country
Romania
Facility Name
Site 703
City
Bucharest
Country
Romania
Facility Name
Site 700
City
Cluj-Napoca
Country
Romania
Facility Name
Site 702
City
Iasi
Country
Romania
Facility Name
Site 705
City
Targu-Mures
Country
Romania
Facility Name
Site 807
City
Kharkiv
Country
Ukraine
Facility Name
Site 811
City
Kharkiv
Country
Ukraine
Facility Name
Site 812
City
Kharkiv
Country
Ukraine
Facility Name
Site 800
City
Kiev
Country
Ukraine
Facility Name
Site 803
City
Kiev
Country
Ukraine
Facility Name
Site 808
City
Kiev
Country
Ukraine
Facility Name
Site 809
City
Kiev
Country
Ukraine
Facility Name
Site 810
City
Kiev
Country
Ukraine
Facility Name
Site 813
City
Kiev
Country
Ukraine
Facility Name
Site 805
City
Lviv
Country
Ukraine
Facility Name
Site 804
City
Odessa
Country
Ukraine
Facility Name
Site 802
City
Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

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Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

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