Acceptability of a Fixed Combination of Fenofibrate and Metformin

This study has been completed.

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

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00348725

Purpose

The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin 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:

Quotation by Visual Numeric Rating Scale before and after 4-week treatment

Secondary Outcome Measures:

Assessment of safety by reporting of Adverse Events

Estimated Enrollment:	69
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	20 Years to 80 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, 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: NCT00348725

Locations

France
Site 1
Nort sur Erdre, France
Site 2
Nantes, France
Site 4
Saint Herblain, France
Site 5
Le Temple de Bretagne, France
Site 7
Saint Aignan le Grand, France
Site 8
Nantes, France
Site 9
Nantes, France
Site 10
St Etienne de Montluc, France
Site 11
Sautron, France
Site 12
Thouars, France
Site 13
Parcay les Pins, France
Site 17
Segre, France
Site 34
Briollay, France
Site 21
Baune, France
Site 23
Bachant, France
Site 24
Anzin, France
Site 25
Vieux Conde, France
Site 26
Quarouble, France
Site 27
Denain, France
Site 28
Denain, France
Site 29
Nantes, France
Site 30
Saint-Amand, France
Site 32
Bersee, France
Site 33
Thiant, France
Site 20
Vihiers, France

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 04 02
Study First Received:	July 5, 2006
Last Updated:	August 31, 2007
ClinicalTrials.gov Identifier:	NCT00348725 History of Changes
Health Authority:	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:

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 February 08, 2010