Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
- Conditions
- Dyslipidemia/Glucose Metabolism Disorder
- Interventions
- Registration Number
- NCT00362323
- Lead Sponsor
- Solvay Pharmaceuticals
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 482
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 fenofibrate (F) + metformin (M) hydrochloride fixed combination - 2 Metformin -
- Primary Outcome Measures
Name Time Method TG / HDL-C ratio 24 weeks
- Secondary Outcome Measures
Name Time Method Lipid and glycemic parameters 24 weeks
Trial Locations
- Locations (70)
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, Czech Republic
C LF23-0121 06 01 Site 204
🇫🇷Bailleul, France
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