drugset / Trial / NCT00361868
Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-06
- Primary completion
- 2007-12
- Completion
- 2007-12
Outcome
Outcome not reported
Stopped: “The study was discontinued prematurely at the end of March 2007 due to slow enrolment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenofibrate | Small molecule | 54 mg | Oral |
| Subject | Metformin | Small molecule | 850 mg | Oral |
| Comparator | Rosiglitazone | Small molecule | 4 mg | Oral |