Clinical trial NCT00361868: 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
Overall status: TERMINATED
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: 2006-08-09
Enrollment: 88
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: 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.


Eligibility criteria: Inclusion Criteria:

* Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.

Exclusion Criteria:

* Type 1 diabetes.

Primary outcomes:
measure: HbA1c/TG
timeFrame: 24 weeks
Secondary outcomes:
measure: Lipid and glycemic parameters.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Pula
country: Croatia
facility: Site105
city: Rijeka
country: Croatia
facility: Site102
city: Split
country: Croatia
facility: Site103
city: Varazdin
country: Croatia
facility: Site104
city: Zagreb
country: Croatia
facility: Site100
city: Zagreb
country: Croatia
facility: Site101
city: Jyväskylä
country: Finland
facility: Site 205
city: Kokkola
country: Finland
facility: Site 206
city: Laukaa
country: Finland
facility: Site 208
city: Oulu
country: Finland
facility: Site 207
city: Bassens
country: France
facility: Site 303
city: Bordeaux
country: France
facility: Site 307
city: Murs Erigne
country: France
facility: Site 305
city: Seysses
country: France
facility: Site 302
city: Strasbourg
country: France
facility: Site 304
city: Thouars
country: France
facility: Site 301
city: Vihiers
country: France
facility: Site 306
city: Berlin
country: Germany
facility: Site 405
city: Borna
country: Germany
facility: Site 410
city: Bretten
country: Germany
facility: Site 403
city: Dresden
country: Germany
facility: Site 402
city: Frankfurt
country: Germany
facility: Site 404
city: Freiburg
country: Germany
facility: Site 400
city: Hannover
country: Germany
facility: Site 401
city: Ilvesheim
country: Germany
facility: Site 409
city: Ilvesheim
country: Germany
facility: Site 411
city: Leipzig
country: Germany
facility: Site 407
city: Rodgau
country: Germany
facility: Site 406
city: Rotenburg
country: Germany
facility: Site 413
city: Schwerin
country: Germany
facility: Site 408
city: Villingen-Schwenningen
country: Germany
facility: Site 412
city: Almere
country: Netherlands
facility: Site 509
city: Breda
country: Netherlands
facility: Site 502
city: Eindhoven
country: Netherlands
facility: Site 503
city: Groningen
country: Netherlands
facility: Site 504
city: Leiden
country: Netherlands
facility: Site 505
city: Nijmegen
country: Netherlands
facility: Site 506
city: Rotterdam
country: Netherlands
facility: Site 500
city: Velp
country: Netherlands
facility: Site 507
city: Zoetermeer
country: Netherlands
facility: Site 508
city: Bialystok
country: Poland
facility: Site 610
city: Elblag
country: Poland
facility: Site 606
city: Gdansk
country: Poland
facility: Site 608
city: Lodz
country: Poland
facility: Site 600
city: Otolinska
country: Poland
facility: Site 605
city: Radom
country: Poland
facility: Site 604
city: Starogard Gdanski
country: Poland
facility: Site 613
city: Warszawa
country: Poland
facility: Site 601
city: Warszawa
country: Poland
facility: Site 607
city: Warszawa
country: Poland
facility: Site 612
city: Wroclaw
country: Poland
facility: Site 602
city: Wroclaw
country: Poland
facility: Site 603
city: Brasov
country: Romania
facility: Site 704
city: Bucharest
country: Romania
facility: Site 701
city: Bucharest
country: Romania
facility: Site 703
city: Cluj-Napoca
country: Romania
facility: Site 700
city: Iasi
country: Romania
facility: Site 702
city: Targu-Mures
country: Romania
facility: Site 705
city: Kharkiv
country: Ukraine
facility: Site 807
city: Kharkiv
country: Ukraine
facility: Site 811
city: Kharkiv
country: Ukraine
facility: Site 812
city: Kiev
country: Ukraine
facility: Site 800
city: Kiev
country: Ukraine
facility: Site 803
city: Kiev
country: Ukraine
facility: Site 808
city: Kiev
country: Ukraine
facility: Site 809
city: Kiev
country: Ukraine
facility: Site 810
city: Kiev
country: Ukraine
facility: Site 813
city: Lviv
country: Ukraine
facility: Site 805
city: Odessa
country: Ukraine
facility: Site 804
city: Vinnitsa
country: Ukraine
facility: Site 802
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: