Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
Phase 3
Terminated
- Conditions
- DyslipidemiaGlucose Metabolism Disorder
- Interventions
- Registration Number
- NCT00361868
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.
Exclusion Criteria
- Type 1 diabetes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 fenofibrate (F) + metformin (M) hydrochloride fixed combination - 2 Rosiglitazone -
- Primary Outcome Measures
Name Time Method HbA1c/TG 24 weeks
- Secondary Outcome Measures
Name Time Method Lipid and glycemic parameters. 24 weeks
Trial Locations
- Locations (70)
Site105
🇭🇷Pula, Croatia
Site102
🇭🇷Rijeka, Croatia
Site103
🇭🇷Split, Croatia
Site104
🇭🇷Varazdin, Croatia
Site100
🇭🇷Zagreb, Croatia
Site101
🇭🇷Zagreb, Croatia
Site 205
🇫🇮Jyväskylä, Finland
Site 206
🇫🇮Kokkola, Finland
Site 208
🇫🇮Laukaa, Finland
Site 207
🇫🇮Oulu, Finland
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