Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00361868
• Other study ID #: C LF23-0121 05 01
• Secondary ID: 2005-006060-63
• Status: Terminated
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: June 26, 2008
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Type 1 diabetes.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Glucose Metabolism Disorder
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• fenofibrate (F) + metformin (M) hydrochloride fixed combination
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
• Rosiglitazone
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks

Locations

Country	Name	City	State
Croatia	Site105	Pula
Croatia	Site102	Rijeka
Croatia	Site103	Split
Croatia	Site104	Varazdin
Croatia	Site100	Zagreb
Croatia	Site101	Zagreb
Finland	Site 205	Jyväskylä
Finland	Site 206	Kokkola
Finland	Site 208	Laukaa
Finland	Site 207	Oulu
France	Site 303	Bassens
France	Site 307	Bordeaux
France	Site 305	Murs Erigne
France	Site 302	Seysses
France	Site 304	Strasbourg
France	Site 301	Thouars
France	Site 306	Vihiers
Germany	Site 405	Berlin
Germany	Site 410	Borna
Germany	Site 403	Bretten
Germany	Site 402	Dresden
Germany	Site 404	Frankfurt
Germany	Site 400	Freiburg
Germany	Site 401	Hannover
Germany	Site 409	Ilvesheim
Germany	Site 411	Ilvesheim
Germany	Site 407	Leipzig
Germany	Site 406	Rodgau
Germany	Site 413	Rotenburg
Germany	Site 408	Schwerin
Germany	Site 412	Villingen-Schwenningen
Netherlands	Site 509	Almere
Netherlands	Site 502	Breda
Netherlands	Site 503	Eindhoven
Netherlands	Site 504	Groningen
Netherlands	Site 505	Leiden
Netherlands	Site 506	Nijmegen
Netherlands	Site 500	Rotterdam
Netherlands	Site 507	Velp
Netherlands	Site 508	Zoetermeer
Poland	Site 610	Bialystok
Poland	Site 606	Elblag
Poland	Site 608	Gdansk
Poland	Site 600	Lodz
Poland	Site 605	Otolinska
Poland	Site 604	Radom
Poland	Site 613	Starogard Gdanski
Poland	Site 601	Warszawa
Poland	Site 607	Warszawa
Poland	Site 612	Warszawa
Poland	Site 602	Wroclaw
Poland	Site 603	Wroclaw
Romania	Site 704	Brasov
Romania	Site 701	Bucharest
Romania	Site 703	Bucharest
Romania	Site 700	Cluj-Napoca
Romania	Site 702	Iasi
Romania	Site 705	Targu-Mures
Ukraine	Site 807	Kharkiv
Ukraine	Site 811	Kharkiv
Ukraine	Site 812	Kharkiv
Ukraine	Site 800	Kiev
Ukraine	Site 803	Kiev
Ukraine	Site 808	Kiev
Ukraine	Site 809	Kiev
Ukraine	Site 810	Kiev
Ukraine	Site 813	Kiev
Ukraine	Site 805	Lviv
Ukraine	Site 804	Odessa
Ukraine	Site 802	Vinnitsa

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Croatia,  Finland,  France,  Germany,  Netherlands,  Poland,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c/TG		24 weeks	No
Secondary	Lipid and glycemic parameters.		24 weeks	No