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

Solvay

Status and phase

Completed

Phase 3

Conditions

Dyslipidemia

Diabetes Mellitus, Type 2

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00490178

2006-002848-28

C LF23-0121 06 02

Details and patient eligibility

About

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

Enrollment

29 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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.