Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Dyslipidemia/Glucose Metabolism Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362323
• Other study ID #: C LF23-0121 06 01
• Secondary ID: 2006-000924-15
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2006
• Last updated: April 15, 2010
• Start date: October 2006
• Est. completion date: March 2009

Study information

• Verified date: April 2010
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Francaise de Securite Sanitaire des Produits de SanteHungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlIndia: Drugs Controller General of IndiaLithuania: SMCA State Medicines Control Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: March 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

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/Glucose Metabolism Disorder
• Dyslipidemias
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• fenofibrate (F) + metformin (M) hydrochloride fixed combination
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
• Metformin
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

Locations

Country	Name	City	State
Czech Republic	C LF23-0121 06 01 Site107	Brno
Czech Republic	C LF23-0121 06 01 Site108	Holesov
Czech Republic	C LF23-0121 06 01 Site101	Karlovy Vary
Czech Republic	C LF23-0121 06 01 Site106	Olomouc
Czech Republic	C LF23-0121 06 01 Site109	Olomouc
Czech Republic	C LF23-0121 06 01 Site103	Pardubice
Czech Republic	C LF23-0121 06 01 Site102	Praha
Czech Republic	C LF23-0121 06 01 Site104	Praha
Czech Republic	C LF23-0121 06 01 Site105	Praha
France	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	Evreux
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
Hungary	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
India	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	Nasik
India	C LF23-0121 06 01 Site 506	Pune
India	C LF23-0121 06 01 Site 514	Tiruvanathapuram-Kerala
Lithuania	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
Poland	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	Grudziadz
Poland	C LF23-0121 06 01 Site 603	Katowice
Poland	C LF23-0121 06 01 Site 601	Kraków
Poland	C LF23-0121 06 01 Site 607	Kraków
Poland	C LF23-0121 06 01 Site 610	Kraków
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 Gdanski
Poland	C LF23-0121 06 01 Site 616	Szczecin
Poland	C LF23-0121 06 01 Site 602	Warszawa
Poland	C LF23-0121 06 01 Site 608	Warszawa
Poland	C LF23-0121 06 01 Site 619	Warszawa
Poland	C LF23-0121 06 01 Site 620	Warszawa
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
Slovakia	C LF23-0121 06 01 Site 700	Bratislava
Slovakia	C LF23-0121 06 01 Site 703	Kosice
Slovakia	C LF23-0121 06 01 Site 702	Lucenec
Slovakia	C LF23-0121 06 01 Site 701	Skalica

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Czech Republic,  France,  Hungary,  India,  Lithuania,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TG / HDL-C ratio		24 weeks	No
Secondary	Lipid and glycemic parameters		24 weeks	No