Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

This study has been completed.

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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 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

ClinicalTrials.gov Identifier:	NCT00349128 History of Changes
Other Study ID Numbers:	C LF23-0121 03 01
Study First Received:	July 5, 2006
Last Updated:	August 31, 2007
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

Additional relevant MeSH terms:

Metabolic Diseases
Dyslipidemias
Glucose Metabolism Disorders
Lipid Metabolism Disorders
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 February 09, 2012