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Acceptability of a Fixed Combination of Fenofibrate and Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348725
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : September 3, 2007
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Quotation by Visual Numeric Rating Scale before and after 4-week treatment

Secondary Outcome Measures :
  1. Assessment of safety by reporting of Adverse Events


Information from the National Library of Medicine

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

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): NCT00348725


Locations
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Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
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ClinicalTrials.gov Identifier: NCT00348725    
Other Study ID Numbers: C LF23-0121 04 02
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:
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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