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

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type II diabetes, dyslipidemia, metformin, fenofibrate, synordia Read More

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.