Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362323
First received: August 9, 2006
Last updated: April 15, 2010
Last verified: April 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 9, 2006 | ||||
| Last Updated Date | April 15, 2010 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
TG / HDL-C ratio [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
TG/HDL after 24 weeks treatment | ||||
| Change History | Complete list of historical versions of study NCT00362323 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Lipid and glycemic parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Lipid and glycemic parameters | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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 |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Dyslipidemia/Glucose Metabolism Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 482 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Czech Republic, France, Hungary, India, Lithuania, Poland, Slovakia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00362323 | ||||
| Other Study ID Numbers ICMJE | C LF23-0121 06 01, 2006-000924-15 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | |||||
| Study Sponsor ICMJE | Solvay Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Solvay Pharmaceuticals | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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