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Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2; Dyslipidemia

Intervention: Fenofibrate 80 mg and metformin 1000 mg (fixed combination) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Site 3, Marseille, France

Site 1, Nantes, France

Site 2, Tours, France

Additional Information

Starting date: March 2007
Last updated: August 31, 2007

Page last updated: August 23, 2015

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