Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Solvay

Status and phase: Terminated; Phase 3

Conditions: Dyslipidemia; Glucose Metabolism Disorder

Treatments: Drug: Rosiglitazone; Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00361868

C LF23-0121 05 01

2005-006060-63

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Type 1 diabetes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination

2

Active Comparator group

Treatment:

Drug: Rosiglitazone