Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

This study has been terminated.

( The study was prematurely terminated, due to difficulties in the recruitment of T2DM patients who are not under statin therapy at inclusion. )

First Received: August 9, 2006 Last Updated: August 12, 2008 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00362765

Purpose

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	Intervention	Phase
Type 2 Diabetes Dyslipidemia	Drug: Fenofibrate Drug: Metformin Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Procetofen Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	October 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: Fenofibrate 160 mg Drug: Metformin 2000 mg
2: Active Comparator	Drug: Fenofibrate 160 mg
3: Active Comparator	Drug: Metformin 2000 mg
4: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

Type 1 diabetes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362765

Locations

Finland
Site 2
Turku, Finland
Ireland
Site 3
Dublin, Ireland
Italy
Site 1
Pisa, Italy

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Philippe Jais )
Study ID Numbers:	C LF23-0121 05 03, 2005-003347-31
Study First Received:	August 9, 2006
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00362765 History of Changes
Health Authority:	Ireland: Irish Medicines Board; Finland: Finnish Medicines Agency; Italy: The Italian Medicines Agency

Keywords provided by Solvay Pharmaceuticals:

Type 2 Diabetes
Dyslipidemia
Hyperinsulinemic

Clamp
Metformin
Fenofibrate

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases

Procetofen
Pharmacologic Actions
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010