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.
2 other identifiers
interventional
482
7 countries
70
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedApril 16, 2010
April 1, 2010
1.8 years
August 9, 2006
April 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TG / HDL-C ratio
24 weeks
Secondary Outcomes (1)
Lipid and glycemic parameters
24 weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
C LF23-0121 06 01 Site107
Brno, Czechia
C LF23-0121 06 01 Site108
Holešov, Czechia
C LF23-0121 06 01 Site101
Karlovy Vary, Czechia
C LF23-0121 06 01 Site106
Olomouc, Czechia
C LF23-0121 06 01 Site109
Olomouc, Czechia
C LF23-0121 06 01 Site103
Pardubice, Czechia
C LF23-0121 06 01 Site102
Prague, Czechia
C LF23-0121 06 01 Site104
Prague, Czechia
C LF23-0121 06 01 Site105
Prague, Czechia
C LF23-0121 06 01 Site 204
Bailleul, France
C LF23-0121 06 01 Site 200
Bondy, France
C LF23-0121 06 01 Site 207
Cholet, France
C LF23-0121 06 01 Site 208
Évreux, France
C LF23-0121 06 01 Site 201
Pantin, France
C LF23-0121 06 01 Site 202
Tours, France
C LF23-0121 06 01 Site 205
Wattrelos, France
C LF23-0121 06 01 Site 406
Balatonfüred, 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
Budapest, Hungary
C LF23-0121 06 01 Site 404
Debrecen, Hungary
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
Bangalore, India
C LF23-0121 06 01 Site 508
Chennai, India
C LF23-0121 06 01 Site 510
Chennai, 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
Hyderabad, India
C LF23-0121 06 01 Site 511
Karnataka, India
C LF23-0121 06 01 Site 512
Maharashtra, India
C LF23-0121 06 01 Site 502
Mumbai, India
C LF23-0121 06 01 Site 503
Mumbai, India
C LF23-0121 06 01 Site 518
Nashik, India
C LF23-0121 06 01 Site 506
Pune, India
C LF23-0121 06 01 Site 514
Tiruvanathapuram-Kerala, India
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
Vilnius, Lithuania
C LF23-0121 06 01 Site 600
Bialystok, Poland
C LF23-0121 06 01 Site 613
Bydgoszcz, Poland
C LF23-0121 06 01 Site 618
Grudziądz, Poland
C LF23-0121 06 01 Site 603
Katowice, Poland
C LF23-0121 06 01 Site 601
Krakow, Poland
C LF23-0121 06 01 Site 607
Krakow, Poland
C LF23-0121 06 01 Site 610
Krakow, Poland
C LF23-0121 06 01 Site 615
Kutno, Poland
C LF23-0121 06 01 Site 605
Olsztyn, Poland
C LF23-0121 06 01 Site 604
Opole, Poland
C LF23-0121 06 01 Site 606
Poznan, Poland
C LF23-0121 06 01 Site 609
Poznan, Poland
C LF23-0121 06 01 Site 621
Sliwinska, Poland
C LF23-0121 06 01 Site 617
Starogard Gdański, Poland
C LF23-0121 06 01 Site 616
Szczecin, Poland
C LF23-0121 06 01 Site 602
Warsaw, Poland
C LF23-0121 06 01 Site 608
Warsaw, Poland
C LF23-0121 06 01 Site 619
Warsaw, Poland
C LF23-0121 06 01 Site 620
Warsaw, Poland
C LF23-0121 06 01 Site 611
Wroclaw, Poland
C LF23-0121 06 01 Site 612
Wroclaw, Poland
C LF23-0121 06 01 Site 614
Zgierz, Poland
C LF23-0121 06 01 Site 700
Bratislava, Slovakia
C LF23-0121 06 01 Site 703
Košice, Slovakia
C LF23-0121 06 01 Site 702
Lučenec, Slovakia
C LF23-0121 06 01 Site 701
Skalica, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michel Conte
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2006
First Posted
August 10, 2006
Study Start
October 1, 2006
Primary Completion
August 1, 2008
Study Completion
March 1, 2009
Last Updated
April 16, 2010
Record last verified: 2010-04