Clinical trial NCT00362323: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia/Glucose Metabolism Disorder
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: TG / HDL-C ratio
timeFrame: 24 weeks
Secondary outcomes:
measure: Lipid and glycemic parameters
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: C LF23-0121 06 01 Site107
city: Holesov
country: Czech Republic
facility: C LF23-0121 06 01 Site108
city: Karlovy Vary
country: Czech Republic
facility: C LF23-0121 06 01 Site101
city: Olomouc
country: Czech Republic
facility: C LF23-0121 06 01 Site106
city: Olomouc
country: Czech Republic
facility: C LF23-0121 06 01 Site109
city: Pardubice
country: Czech Republic
facility: C LF23-0121 06 01 Site103
city: Praha
country: Czech Republic
facility: C LF23-0121 06 01 Site102
city: Praha
country: Czech Republic
facility: C LF23-0121 06 01 Site104
city: Praha
country: Czech Republic
facility: C LF23-0121 06 01 Site105
city: Bailleul
country: France
facility: C LF23-0121 06 01 Site 204
city: Bondy
country: France
facility: C LF23-0121 06 01 Site 200
city: Cholet
country: France
facility: C LF23-0121 06 01 Site 207
city: Evreux
country: France
facility: C LF23-0121 06 01 Site 208
city: Pantin
country: France
facility: C LF23-0121 06 01 Site 201
city: Tours
country: France
facility: C LF23-0121 06 01 Site 202
city: Wattrelos
country: France
facility: C LF23-0121 06 01 Site 205
city: Balatonfüred
country: Hungary
facility: C LF23-0121 06 01 Site 406
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 400
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 401
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 402
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 403
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 405
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 407
city: Budapest
country: Hungary
facility: C LF23-0121 06 01 Site 408
city: Debrecen
country: Hungary
facility: C LF23-0121 06 01 Site 404
city: Bangalore
country: India
facility: C LF23-0121 06 01 Site 501
city: Bangalore
country: India
facility: C LF23-0121 06 01 Site 504
city: Bangalore
country: India
facility: C LF23-0121 06 01 Site 516
city: Bangalore
country: India
facility: C LF23-0121 06 01 Site 519
city: Chennai
country: India
facility: C LF23-0121 06 01 Site 508
city: Chennai
country: India
facility: C LF23-0121 06 01 Site 510
city: Hyderabad
country: India
facility: C LF23-0121 06 01 Site 505
city: Hyderabad
country: India
facility: C LF23-0121 06 01 Site 509
city: Hyderabad
country: India
facility: C LF23-0121 06 01 Site 517
city: Karnataka
country: India
facility: C LF23-0121 06 01 Site 511
city: Maharashtra
country: India
facility: C LF23-0121 06 01 Site 512
city: Mumbai
country: India
facility: C LF23-0121 06 01 Site 502
city: Mumbai
country: India
facility: C LF23-0121 06 01 Site 503
city: Nasik
country: India
facility: C LF23-0121 06 01 Site 518
city: Pune
country: India
facility: C LF23-0121 06 01 Site 506
city: Tiruvanathapuram-Kerala
country: India
facility: C LF23-0121 06 01 Site 514
city: Vilnius
country: Lithuania
facility: C LF23-0121 06 01 Site 800
city: Vilnius
country: Lithuania
facility: C LF23-0121 06 01 Site 801
city: Vilnius
country: Lithuania
facility: C LF23-0121 06 01 Site 802
city: Bialystok
country: Poland
facility: C LF23-0121 06 01 Site 600
city: Bydgoszcz
country: Poland
facility: C LF23-0121 06 01 Site 613
city: Grudziadz
country: Poland
facility: C LF23-0121 06 01 Site 618
city: Katowice
country: Poland
facility: C LF23-0121 06 01 Site 603
city: Kraków
country: Poland
facility: C LF23-0121 06 01 Site 601
city: Kraków
country: Poland
facility: C LF23-0121 06 01 Site 607
city: Kraków
country: Poland
facility: C LF23-0121 06 01 Site 610
city: Kutno
country: Poland
facility: C LF23-0121 06 01 Site 615
city: Olsztyn
country: Poland
facility: C LF23-0121 06 01 Site 605
city: Opole
country: Poland
facility: C LF23-0121 06 01 Site 604
city: Poznan
country: Poland
facility: C LF23-0121 06 01 Site 606
city: Poznan
country: Poland
facility: C LF23-0121 06 01 Site 609
city: Sliwinska
country: Poland
facility: C LF23-0121 06 01 Site 621
city: Starogard Gdanski
country: Poland
facility: C LF23-0121 06 01 Site 617
city: Szczecin
country: Poland
facility: C LF23-0121 06 01 Site 616
city: Warszawa
country: Poland
facility: C LF23-0121 06 01 Site 602
city: Warszawa
country: Poland
facility: C LF23-0121 06 01 Site 608
city: Warszawa
country: Poland
facility: C LF23-0121 06 01 Site 619
city: Warszawa
country: Poland
facility: C LF23-0121 06 01 Site 620
city: Wroclaw
country: Poland
facility: C LF23-0121 06 01 Site 611
city: Wroclaw
country: Poland
facility: C LF23-0121 06 01 Site 612
city: Zgierz
country: Poland
facility: C LF23-0121 06 01 Site 614
city: Bratislava
country: Slovakia
facility: C LF23-0121 06 01 Site 700
city: Kosice
country: Slovakia
facility: C LF23-0121 06 01 Site 703
city: Lucenec
country: Slovakia
facility: C LF23-0121 06 01 Site 702
city: Skalica
country: Slovakia
facility: C LF23-0121 06 01 Site 701
Study officials:
affiliation: Solvay Pharmaceuticals
name: Michel Conte
role: STUDY_DIRECTOR
References: