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.)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362765
First received: August 9, 2006
Last updated: August 12, 2008
Last verified: August 2008

August 9, 2006
August 12, 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 ] [ Designated as safety issue: No ]
Hyperinsulinemic euglycemic clamp
Complete list of historical versions of study NCT00362765 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Dyslipidemia
  • Drug: Fenofibrate
    160 mg
  • Drug: Metformin
    2000 mg
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
July 2007
Not Provided

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

  • Type 1 diabetes.
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Finland,   Ireland
 
NCT00362765
C LF23-0121 05 03, 2005-003347-31
No
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