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

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00490178

Collaborator

(none)

Enrollment

Locations

9.7

Patients Per Site

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Dyslipidemia	Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients aged from 20 to 80 years (at inclusion visit).
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.
Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
And having signed a written informed consent.-

Exclusion Criteria:

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)].
TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
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).
Pregnant or lactating women.