Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
Overview[ - collapse ][ - ]
| 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 | Dyslipidemia/Glucose Metabolism Disorder |
| Intervention | Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination Drug: Metformin |
| Phase | Phase 3 |
| Sponsor | Solvay Pharmaceuticals |
| Responsible Party | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00362323 |
| First Received | August 9, 2006 |
| Last Updated | April 15, 2010 |
| Last verified | April 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 9, 2006 |
|---|---|
| Last Updated Date | April 15, 2010 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | March 2009 |
| Current Primary Outcome Measures | TG / HDL-C ratio [Time Frame: 24 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Lipid and glycemic parameters [Time Frame: 24 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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. |
| 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Dyslipidemia/Glucose Metabolism Disorder |
| 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 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 482 |
| Estimated Completion Date | March 2009 |
| Estimated Primary Completion Date | August 2008 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Czech Republic, France, Hungary, India, Lithuania, Poland, Slovakia |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00362323 |
|---|---|
| Other Study ID Numbers | C LF23-0121 06 01 |
| Has Data Monitoring Committee | No |
| Information Provided By | Solvay Pharmaceuticals |
| Study Sponsor | Solvay Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Michel Conte Solvay Pharmaceuticals |
| Verification Date | April 2010 |
Locations[ + expand ][ + ]
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |