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Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

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ClinicalTrials.gov Identifier: NCT00349128
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : September 3, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidemia/Glucose Metabolism Disorder Drug: fenofibrate and metformin combination (drug) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change in fasting triglycerides.

Secondary Outcome Measures :
  1. Assessment of lipid and glucose metabolisms.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349128


  Show 51 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information

ClinicalTrials.gov Identifier: NCT00349128     History of Changes
Other Study ID Numbers: C LF23-0121 03 01
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: September 3, 2007
Last Verified: August 2007

Keywords provided by Solvay Pharmaceuticals:
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Dyslipidemias
Metabolic Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metformin
Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents