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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:
ClinicalTrials.gov Identifier:
NCT00362765
First Posted: August 10, 2006
Last Update Posted: August 13, 2008
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.
Information provided by:
Solvay Pharmaceuticals
  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 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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 ]

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 ]

Enrollment: 8
Study Start Date: October 2006
Study Completion Date: July 2007
Arms Assigned Interventions
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
Placebo

  Eligibility

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
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

  • Type 1 diabetes.
  Contacts and Locations
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


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

Responsible Party: Philippe Jais, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00362765     History of Changes
Other Study ID Numbers: C LF23-0121 05 03
2005-003347-31
First Submitted: August 9, 2006
First Posted: August 10, 2006
Last Update Posted: August 13, 2008
Last Verified: August 2008

Keywords provided by Solvay Pharmaceuticals:
Type 2 Diabetes
Dyslipidemia
Hyperinsulinemic
Clamp
Metformin
Fenofibrate

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