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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00349128 |
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 | Intervention | Phase |
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Dyslipidemia/Glucose Metabolism Disorder |
Drug: fenofibrate and metformin combination (drug) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Study ID Numbers: | C LF23-0121 03 01 |
Study First Received: | July 5, 2006 |
Last Updated: | August 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00349128 |
Health Authority: | Ukraine: State Pharmacological Center - Ministry of Health; Poland: Ministry of Health; France: Afssaps - French Health Products Safety Agency |
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Metabolic disorder |
Glucose Metabolism Disorders Procetofen Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Physiological Effects of Drugs Pharmacologic Actions |