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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Philippe Jais, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00362765     History of Changes
Other Study ID Numbers: C LF23-0121 05 03, 2005-003347-31
Study First Received: August 9, 2006
Last Updated: August 12, 2008
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Hyperinsulinism
Metformin
Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014