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| Sponsor: | Solvay Pharmaceuticals |
|---|---|
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00362323 |
Purpose
To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia/Glucose Metabolism Disorder |
Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination Drug: Metformin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin. |
| Enrollment: | 482 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
|
| Active Comparator: 2 |
Drug: Metformin
500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.
Exclusion Criteria Type 1 diabetes.
Contacts and Locations
Show 70 Study Locations| Study Director: | Michel Conte | Solvay Pharmaceuticals |
More Information
| ClinicalTrials.gov Identifier: | NCT00362323 History of Changes |
| Other Study ID Numbers: | C LF23-0121 06 01, 2006-000924-15 |
| Study First Received: | August 9, 2006 |
| Last Updated: | April 15, 2010 |
| Health Authority: | France: Agence Francaise de Securite Sanitaire des Produits de Sante; Hungary: National Institute of Pharmacy; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; India: Drugs Controller General of India; Lithuania: SMCA State Medicines Control Agency |
|
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Dyslipidemias Glucose Metabolism Disorders Endocrine System Diseases Lipid Metabolism Disorders Metformin Fenofibrate |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Therapeutic Uses |
