Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes - Full Text View

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

MedlinePlus related topics: Diabetes Metabolic Disorders

Drug Information available for: Metformin Metformin hydrochloride Procetofen Lipids

U.S. FDA Resources

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.

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

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

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Metabolic disorder

Glucose Metabolism Disorders
Procetofen
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009