Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Phase 2

Terminated

• Conditions: Type 2 Diabetes; Dyslipidemia
• Interventions: Drug: Fenofibrate; Drug: Placebo; Drug: Metformin

• Registration Number: NCT00362765
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Study Start: 2006-10
• Study Completion: 2007-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-12
• Last Update Posted: 2008-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria

• Type 1 diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fenofibrate	-
1	Metformin	-
2	Fenofibrate	-
3	Metformin	-
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)	16 weeks

Secondary Outcome Measures

Name	Time	Method
Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters	16 weeks

Trial Locations

Locations (3)

Site 3; 🇮🇪 Dublin, Ireland

Site 2; 🇫🇮 Turku, Finland

Site 1; 🇮🇹 Pisa, Italy