Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

August 31, 2007 updated by: Solvay Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

382

Phase

  • Phase 2
  • 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

  • Poland
      • Katowice, Poland
        • Site 201
      • Katowice, Poland
        • Site 203
      • Warszawa, Poland
        • Site 202
      • Zabrze, Poland
        • Site 204
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Site 111
      • Dnipropetrovsk, Ukraine
        • Site 113
      • Kharkiv, Ukraine
        • Site 108
      • Kharkiv, Ukraine
        • Site 109
      • Kyiv, Ukraine
        • Site 101
      • Kyiv, Ukraine
        • Site 102
      • Kyiv, Ukraine
        • Site 103
      • Kyiv, Ukraine
        • Site 104
      • Kyiv, Ukraine
        • Site 105
      • Kyiv, Ukraine
        • Site 106
      • Kyiv, Ukraine
        • Site 107
      • Zaporizhya, Ukraine
        • Site 112
  • United Kingdom
      • Acomb, United Kingdom
        • Site 35
      • Atherstone, United Kingdom
        • Site 21
      • Balsall Common, United Kingdom
        • Site 14
      • Bangor, United Kingdom
        • Site 32
      • Barry, United Kingdom
        • Site 23
      • Basingstoke, United Kingdom
        • Site 36
      • Bexhill-on-Sea, United Kingdom
        • Site 8
      • Camberley, United Kingdom
        • Site 20
      • Chesterfield, United Kingdom
        • Site 22
      • Chippenham, United Kingdom
        • Site 10
      • Coventry, United Kingdom
        • Site 13
      • Doncaster, United Kingdom
        • Site 31
      • Downpatrick, United Kingdom
        • Site 15
      • Ely, United Kingdom
        • Site 17
      • Ely, United Kingdom
        • Site 4
      • Fife, United Kingdom
        • Site 11
      • Frome, United Kingdom
        • Site 1
      • Harrow, United Kingdom
        • Site 16
      • Hastings, United Kingdom
        • Site 5
      • Haverfordwest, United Kingdom
        • Site 26
      • Keresley end, United Kingdom
        • Site 19
      • Kingswood, United Kingdom
        • Site 9
      • Newtownabbey, United Kingdom
        • Site 25
      • Northampton, United Kingdom
        • Site 33
      • Odiham, United Kingdom
        • Site 28
      • Paignton, United Kingdom
        • Site 3
      • Petersborough, United Kingdom
        • Site 12
      • Randalstown, United Kingdom
        • Site 7
      • Slough, United Kingdom
        • Site 27
      • Soham, United Kingdom
        • Site 6
      • South Glamorgan, United Kingdom
        • Site 2
      • Stratford on Avon, United Kingdom
        • Site 34
      • Swindon, United Kingdom
        • Site 29
      • Trowbridge, United Kingdom
        • Site 30
      • Yaxley, United Kingdom
        • Site 18

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:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in fasting triglycerides.

Secondary Outcome Measures

Outcome Measure
Assessment of lipid and glucose metabolisms.

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

January 1, 2004

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 03 01

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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