Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

This study has been completed.

First Received: July 5, 2006 Last Updated: August 31, 2007 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00349128

Purpose

The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.

Condition	Intervention	Phase
Dyslipidemia/Glucose Metabolism Disorder	Drug: fenofibrate and metformin combination (drug)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Low and Standard Doses of Fenofibrate in Combination With Metformin on the Lipid Profile in Patients With Type 2 Diabetes and Dyslipidemia.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Metabolic Disorders

Drug Information available for: Procetofen Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Change in fasting triglycerides.

Secondary Outcome Measures:

Assessment of lipid and glucose metabolisms.

Estimated Enrollment:	382
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus

Exclusion Criteria:

Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349128

Show 51 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	C LF23-0121 03 01
Study First Received:	July 5, 2006
Last Updated:	August 31, 2007
ClinicalTrials.gov Identifier:	NCT00349128 History of Changes
Health Authority:	Ukraine: State Pharmacological Center - Ministry of Health; Poland: Ministry of Health; France: Afssaps - French Health Products Safety Agency

Keywords provided by Solvay Pharmaceuticals:

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Study placed in the following topic categories:

Antimetabolites
Hypoglycemic Agents
Metabolic Diseases
Antilipemic Agents
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Glucose Metabolism Disorders
Procetofen
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Metformin
Physiological Effects of Drugs
Procetofen

Pharmacologic Actions
Hypoglycemic Agents
Therapeutic Uses
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009