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. 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

August 9, 2006
August 10, 2006
August 13, 2008
October 2006
Not Provided
Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC) [ Time Frame: 16 weeks ]
Hyperinsulinemic euglycemic clamp
Complete list of historical versions of study NCT00362765 on Archive Site
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 ]
Lipid and glycemic parameters.
Not Provided
Not Provided
Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study
Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Dyslipidemia
  • Drug: Fenofibrate
    160 mg
  • Drug: Metformin
    2000 mg
  • Drug: Placebo
  • Experimental: 1
    • Drug: Fenofibrate
    • Drug: Metformin
  • Active Comparator: 2
    Intervention: Drug: Fenofibrate
  • Active Comparator: 3
    Intervention: Drug: Metformin
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2007
Not Provided

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

  • Type 1 diabetes.
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Finland,   Ireland,   Italy
C LF23-0121 05 03
Not Provided
Not Provided
Philippe Jais, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP