Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Solvay

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Dyslipidemia; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Metformin; Drug: Fenofibrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362765

2005-003347-31

C LF23-0121 05 03

Details and patient eligibility

About

Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.

Enrollment: 8 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion criteria

• Type 1 diabetes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Fenofibrate

Drug: Metformin

2

Active Comparator group

Treatment:

Drug: Fenofibrate

3

Active Comparator group

Treatment:

Drug: Metformin

4

Placebo Comparator group

Treatment:

Drug: Placebo