Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362323
First received: August 9, 2006
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Dyslipidemia/Glucose Metabolism Disorder
Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
Drug: Metformin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • TG / HDL-C ratio [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid and glycemic parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 482
Study Start Date: October 2006
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362323

  Hide Study Locations
Locations
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 Site109
Olomouc, Czech Republic
C LF23-0121 06 01 Site106
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, Czech Republic
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, France
Hungary
C LF23-0121 06 01 Site 406
Balatonfüred, Hungary
C LF23-0121 06 01 Site 403
Budapest, Hungary
C LF23-0121 06 01 Site 402
Budapest, 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 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
India
C LF23-0121 06 01 Site 501
Bangalore, India
C LF23-0121 06 01 Site 519
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 508
Chennai, India
C LF23-0121 06 01 Site 510
Chennai, India
C LF23-0121 06 01 Site 517
Hyderabad, India
C LF23-0121 06 01 Site 509
Hyderabad, India
C LF23-0121 06 01 Site 505
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, India
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, Lithuania
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 610
Kraków, 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 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 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 602
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, Poland
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, Slovakia
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Michel Conte Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00362323     History of Changes
Other Study ID Numbers: C LF23-0121 06 01, 2006-000924-15
Study First Received: August 9, 2006
Last Updated: April 15, 2010
Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
India: Drugs Controller General of India
Lithuania: SMCA State Medicines Control Agency

Keywords provided by Solvay Pharmaceuticals:
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Dyslipidemias
Glucose Metabolism Disorders
Endocrine System Diseases
Lipid Metabolism Disorders
Metformin
Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014