Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361868

Enrollment

Registered

2006-08-09

Start date

2006-06-30

Completion date

2007-12-31

Last updated

2008-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Glucose Metabolism Disorder

Keywords

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

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.

Interventions

DRUGfenofibrate (F) + metformin (M) hydrochloride fixed combination

First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks

DRUGRosiglitazone

First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.

Exclusion criteria

* Type 1 diabetes.

Design outcomes

Primary

Measure	Time frame
HbA1c/TG	24 weeks

Secondary

Measure	Time frame
Lipid and glycemic parameters.	24 weeks

Countries

Croatia, Finland, France, Germany, Netherlands, Poland, Romania, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026