Acceptability of a Fixed Combination of Fenofibrate and Metformin

August 31, 2007 updated by: Solvay Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Assessment of safety by reporting of Adverse Events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2007

Last Update Submitted That Met QC Criteria

August 31, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C LF23-0121 04 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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