Evaluation of efficacy and safety of fixed dose combination of glimepiride 2 mg pluspioglitazone 15 mg plus metformin SR 500 mg in the management of patients with type-2 diabetes mellitus.

ABSTRACT

An estimated 25 million Indians currently have diabetes and the projections indicate Indians would be the largest group by the year 2025 AD. An open, phase III, multicentric study was conducted to determine the efficacy and tolerability of the triple drug combination glimepiride 2 mg plus pioglitazone hydrochloride 15 mg plus metformin SR 500 mg for 8 weeks in 101 Indian patients with type 2 diabetes mellitus. The study revealed that the triple drug combination could achieve the recommended goals, recommended by American Diabetic Association, for fasting blood glucose < or = 140 mg/dl and glycosylated haemoglobin (HbA1c) of < or = 8%. After 8 weeks, the mean fasting blood glucose (baseline 189.61) was reduced to 111.68 (41% reduction); the mean glycosylated haemoglobin (baseline 10.32) was significantly reduced to 7.54 (26% reduction). The triple drug combination significantly reduced the levels of triglyceride, low density lipoproteins and total cholesterol. These significant levels were achieved within 8 weeks and all patients tolerated the drug well with no reported case of serious adverse events including hypoglycaemia. There were also no reported drug interactions in the study. Since the decrease in HbA1c was continuous and throughout the study, a further decrease in the HbA1c levels would have been noted since the present trial was designed for a period of 8 weeks. Thus, the present study confirms the efficacy and safety of FDC of the triple drug combination in patients with type 2 diabetes.