search
Back to results

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Primary Purpose

Dyslipidemia/Glucose Metabolism Disorder

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

About this trial

This is an interventional treatment trial for Dyslipidemia/Glucose Metabolism Disorder 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 treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment. Exclusion Criteria Type 1 diabetes.

Sites / Locations

  • C LF23-0121 06 01 Site107
  • C LF23-0121 06 01 Site108
  • C LF23-0121 06 01 Site101
  • C LF23-0121 06 01 Site106
  • C LF23-0121 06 01 Site109
  • C LF23-0121 06 01 Site103
  • C LF23-0121 06 01 Site102
  • C LF23-0121 06 01 Site104
  • C LF23-0121 06 01 Site105
  • C LF23-0121 06 01 Site 204
  • C LF23-0121 06 01 Site 200
  • C LF23-0121 06 01 Site 207
  • C LF23-0121 06 01 Site 208
  • C LF23-0121 06 01 Site 201
  • C LF23-0121 06 01 Site 202
  • C LF23-0121 06 01 Site 205
  • C LF23-0121 06 01 Site 406
  • C LF23-0121 06 01 Site 400
  • C LF23-0121 06 01 Site 401
  • C LF23-0121 06 01 Site 402
  • C LF23-0121 06 01 Site 403
  • C LF23-0121 06 01 Site 405
  • C LF23-0121 06 01 Site 407
  • C LF23-0121 06 01 Site 408
  • C LF23-0121 06 01 Site 404
  • C LF23-0121 06 01 Site 501
  • C LF23-0121 06 01 Site 504
  • C LF23-0121 06 01 Site 516
  • C LF23-0121 06 01 Site 519
  • C LF23-0121 06 01 Site 508
  • C LF23-0121 06 01 Site 510
  • C LF23-0121 06 01 Site 505
  • C LF23-0121 06 01 Site 509
  • C LF23-0121 06 01 Site 517
  • C LF23-0121 06 01 Site 511
  • C LF23-0121 06 01 Site 512
  • C LF23-0121 06 01 Site 502
  • C LF23-0121 06 01 Site 503
  • C LF23-0121 06 01 Site 518
  • C LF23-0121 06 01 Site 506
  • C LF23-0121 06 01 Site 514
  • C LF23-0121 06 01 Site 800
  • C LF23-0121 06 01 Site 801
  • C LF23-0121 06 01 Site 802
  • C LF23-0121 06 01 Site 600
  • C LF23-0121 06 01 Site 613
  • C LF23-0121 06 01 Site 618
  • C LF23-0121 06 01 Site 603
  • C LF23-0121 06 01 Site 601
  • C LF23-0121 06 01 Site 607
  • C LF23-0121 06 01 Site 610
  • C LF23-0121 06 01 Site 615
  • C LF23-0121 06 01 Site 605
  • C LF23-0121 06 01 Site 604
  • C LF23-0121 06 01 Site 606
  • C LF23-0121 06 01 Site 609
  • C LF23-0121 06 01 Site 621
  • C LF23-0121 06 01 Site 617
  • C LF23-0121 06 01 Site 616
  • C LF23-0121 06 01 Site 602
  • C LF23-0121 06 01 Site 608
  • C LF23-0121 06 01 Site 619
  • C LF23-0121 06 01 Site 620
  • C LF23-0121 06 01 Site 611
  • C LF23-0121 06 01 Site 612
  • C LF23-0121 06 01 Site 614
  • C LF23-0121 06 01 Site 700
  • C LF23-0121 06 01 Site 703
  • C LF23-0121 06 01 Site 702
  • C LF23-0121 06 01 Site 701

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

TG / HDL-C ratio

Secondary Outcome Measures

Lipid and glycemic parameters

Full Information

First Posted
August 9, 2006
Last Updated
April 15, 2010
Sponsor
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00362323
Brief Title
Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

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
482 (Actual)

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
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
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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
Primary Outcome Measure Information:
Title
TG / HDL-C ratio
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 treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment. Exclusion Criteria Type 1 diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Conte
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
C LF23-0121 06 01 Site107
City
Brno
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site108
City
Holesov
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site101
City
Karlovy Vary
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site106
City
Olomouc
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site109
City
Olomouc
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site103
City
Pardubice
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site102
City
Praha
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site104
City
Praha
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site105
City
Praha
Country
Czech Republic
Facility Name
C LF23-0121 06 01 Site 204
City
Bailleul
Country
France
Facility Name
C LF23-0121 06 01 Site 200
City
Bondy
Country
France
Facility Name
C LF23-0121 06 01 Site 207
City
Cholet
Country
France
Facility Name
C LF23-0121 06 01 Site 208
City
Evreux
Country
France
Facility Name
C LF23-0121 06 01 Site 201
City
Pantin
Country
France
Facility Name
C LF23-0121 06 01 Site 202
City
Tours
Country
France
Facility Name
C LF23-0121 06 01 Site 205
City
Wattrelos
Country
France
Facility Name
C LF23-0121 06 01 Site 406
City
Balatonfüred
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 400
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 401
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 402
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 403
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 405
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 407
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 408
City
Budapest
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 404
City
Debrecen
Country
Hungary
Facility Name
C LF23-0121 06 01 Site 501
City
Bangalore
Country
India
Facility Name
C LF23-0121 06 01 Site 504
City
Bangalore
Country
India
Facility Name
C LF23-0121 06 01 Site 516
City
Bangalore
Country
India
Facility Name
C LF23-0121 06 01 Site 519
City
Bangalore
Country
India
Facility Name
C LF23-0121 06 01 Site 508
City
Chennai
Country
India
Facility Name
C LF23-0121 06 01 Site 510
City
Chennai
Country
India
Facility Name
C LF23-0121 06 01 Site 505
City
Hyderabad
Country
India
Facility Name
C LF23-0121 06 01 Site 509
City
Hyderabad
Country
India
Facility Name
C LF23-0121 06 01 Site 517
City
Hyderabad
Country
India
Facility Name
C LF23-0121 06 01 Site 511
City
Karnataka
Country
India
Facility Name
C LF23-0121 06 01 Site 512
City
Maharashtra
Country
India
Facility Name
C LF23-0121 06 01 Site 502
City
Mumbai
Country
India
Facility Name
C LF23-0121 06 01 Site 503
City
Mumbai
Country
India
Facility Name
C LF23-0121 06 01 Site 518
City
Nasik
Country
India
Facility Name
C LF23-0121 06 01 Site 506
City
Pune
Country
India
Facility Name
C LF23-0121 06 01 Site 514
City
Tiruvanathapuram-Kerala
Country
India
Facility Name
C LF23-0121 06 01 Site 800
City
Vilnius
Country
Lithuania
Facility Name
C LF23-0121 06 01 Site 801
City
Vilnius
Country
Lithuania
Facility Name
C LF23-0121 06 01 Site 802
City
Vilnius
Country
Lithuania
Facility Name
C LF23-0121 06 01 Site 600
City
Bialystok
Country
Poland
Facility Name
C LF23-0121 06 01 Site 613
City
Bydgoszcz
Country
Poland
Facility Name
C LF23-0121 06 01 Site 618
City
Grudziadz
Country
Poland
Facility Name
C LF23-0121 06 01 Site 603
City
Katowice
Country
Poland
Facility Name
C LF23-0121 06 01 Site 601
City
Kraków
Country
Poland
Facility Name
C LF23-0121 06 01 Site 607
City
Kraków
Country
Poland
Facility Name
C LF23-0121 06 01 Site 610
City
Kraków
Country
Poland
Facility Name
C LF23-0121 06 01 Site 615
City
Kutno
Country
Poland
Facility Name
C LF23-0121 06 01 Site 605
City
Olsztyn
Country
Poland
Facility Name
C LF23-0121 06 01 Site 604
City
Opole
Country
Poland
Facility Name
C LF23-0121 06 01 Site 606
City
Poznan
Country
Poland
Facility Name
C LF23-0121 06 01 Site 609
City
Poznan
Country
Poland
Facility Name
C LF23-0121 06 01 Site 621
City
Sliwinska
Country
Poland
Facility Name
C LF23-0121 06 01 Site 617
City
Starogard Gdanski
Country
Poland
Facility Name
C LF23-0121 06 01 Site 616
City
Szczecin
Country
Poland
Facility Name
C LF23-0121 06 01 Site 602
City
Warszawa
Country
Poland
Facility Name
C LF23-0121 06 01 Site 608
City
Warszawa
Country
Poland
Facility Name
C LF23-0121 06 01 Site 619
City
Warszawa
Country
Poland
Facility Name
C LF23-0121 06 01 Site 620
City
Warszawa
Country
Poland
Facility Name
C LF23-0121 06 01 Site 611
City
Wroclaw
Country
Poland
Facility Name
C LF23-0121 06 01 Site 612
City
Wroclaw
Country
Poland
Facility Name
C LF23-0121 06 01 Site 614
City
Zgierz
Country
Poland
Facility Name
C LF23-0121 06 01 Site 700
City
Bratislava
Country
Slovakia
Facility Name
C LF23-0121 06 01 Site 703
City
Kosice
Country
Slovakia
Facility Name
C LF23-0121 06 01 Site 702
City
Lucenec
Country
Slovakia
Facility Name
C LF23-0121 06 01 Site 701
City
Skalica
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

We'll reach out to this number within 24 hrs