Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Solvay

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia/Glucose Metabolism Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362323

2006-000924-15

C LF23-0121 06 01

Details and patient eligibility

About

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

Enrollment: 482 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.

Exclusion Criteria Type 1 diabetes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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482 participants in 2 patient groups

1

Experimental group

Treatment:

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

2

Active Comparator group

Treatment:

Drug: Metformin