Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00362765

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Dyslipidemia	Drug: Fenofibrate Drug: Metformin Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.

Study Start Date :

Oct 1, 2006

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Fenofibrate 160 mg Drug: Metformin 2000 mg
Active Comparator: 2	Drug: Fenofibrate 160 mg
Active Comparator: 3	Drug: Metformin 2000 mg
Placebo Comparator: 4	Drug: Placebo Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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