Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Phase 3TerminatedNCT00362765

Solvay Pharmaceuticals8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Dyslipidemia

Interventions

FenofibrateDRUG

160 mg

MetforminDRUG

2000 mg

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with type 2 diabetes mellitus and dyslipidemia. Exclusion Criteria: * Type 1 diabetes.

Locations (3)

Site 2

Turku, Finland

Site 3

Dublin, Ireland

Site 1

Pisa, Italy

Outcomes

Primary Outcomes

Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)

Time frame: 16 weeks

Secondary Outcomes

Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters

Time frame: 16 weeks

Data from ClinicalTrials.gov

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