Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
Overview[ - collapse ][ - ]
Purpose | The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia |
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Condition | Diabetes Mellitus, Type 2 Dyslipidemia |
Intervention | Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination) |
Phase | Phase 3 |
Sponsor | Solvay Pharmaceuticals |
Responsible Party | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier | NCT00490178 |
First Received | June 21, 2007 |
Last Updated | August 31, 2007 |
Last verified | August 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | June 21, 2007 |
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Last Updated Date | August 31, 2007 |
Start Date | March 2007 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Not Provided |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia |
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Official Title | An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia |
Brief Summary | The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination) |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 29 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: 1. Male or female patients aged from 20 to 80 years (at inclusion visit). 2. Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent. 3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin. 4. And having signed a written informed consent.- Exclusion Criteria: 1. Known Type 1 Diabetes, uncontrolled type 2 diabetes [HbA1c > 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)]. 2. TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months). 3. Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (> 1 year since their last menstrual period). 4. Pregnant or lactating women. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00490178 |
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Other Study ID Numbers | C LF23-0121 06 02 |
Has Data Monitoring Committee | No |
Information Provided By | Solvay Pharmaceuticals |
Study Sponsor | Solvay Pharmaceuticals |
Collaborators | Not Provided |
Investigators | Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals |
Verification Date | August 2007 |
Locations[ + expand ][ + ]
Site 3 | Marseille, France |
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Site 1 | Nantes, France |
Site 2 | Tours, France |