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Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00362765
Recruitment Status : Terminated (The study was prematurely terminated, due to difficulties in the recruitment of T2DM patients who are not under statin therapy at inclusion.)
First Posted : August 10, 2006
Last Update Posted : August 13, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dyslipidemia Drug: Fenofibrate Drug: Metformin Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
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 : October 2006
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

  • Type 1 diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362765

Site 2
Turku, Finland
Site 3
Dublin, Ireland
Site 1
Pisa, Italy
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Philippe Jais, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00362765     History of Changes
Other Study ID Numbers: C LF23-0121 05 03
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: August 13, 2008
Last Verified: August 2008

Keywords provided by Solvay Pharmaceuticals:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents