Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

This study has been completed.

First Received on June 21, 2007. Last Updated on August 31, 2007 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00490178

Purpose

The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Dyslipidemia	Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID 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

Drug Information available for: Procetofen Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Enrollment:	29
Study Start Date:	March 2007

Eligibility

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

Criteria

Inclusion Criteria:

Male or female patients aged from 20 to 80 years (at inclusion visit).
Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
And having signed a written informed consent.-

Exclusion Criteria:

Known Type 1 Diabetes, uncontrolled type 2 diabetes [HbA1c > 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)].
TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (> 1 year since their last menstrual period).
Pregnant or lactating women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490178

Locations

France
Site 3
Marseille, France
Site 1
Nantes, France
Site 2
Tours, France

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00490178 History of Changes
Other Study ID Numbers:	C LF23-0121 06 02, 2006-002848-28
Study First Received:	June 21, 2007
Last Updated:	August 31, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Solvay Pharmaceuticals:

Type II diabetes
dyslipidemia
metformin
fenofibrate
synordia

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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