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Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes; Dyslipidemia

Intervention: Fenofibrate (Drug); Metformin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

- Type 1 diabetes.

Locations and Contacts

Site 2, Turku, Finland

Site 3, Dublin, Ireland

Site 1, Pisa, Italy

Additional Information

Starting date: October 2006
Last updated: August 12, 2008

Page last updated: August 23, 2015

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