Abstract:

There is paucity of data on triple drug combination containing low dose (7.5 mg) pioglitazone in Indian type 2 diabetes patients (T2DM). Objective: Comparative evaluation of efficacy and safety of glimepiride, metformin (GM) plus low dose pioglitazone fixed dose combination (FDC) in T2DM. Material and methods: In this open label study, 75 insulin naïve T2DM subjects inadequately controlled on GM oral therapy were randomized into Group A: FDC of G 1mg + M 500 mg SR + Pioglitazone 7.5 mg; Group B: FDC of G 2mg + M 500 mg SR + Pioglitazone 7.5 mg or Group C: Insulin 70/30 Mix + M 500mg SR. The primary outcome measure was reduction in HbA1c at 180 days. The secondary end points included reduction in fasting plasma glucose (FPG), postprandial plasma glucose (PPG) and change in lipid parameters and weight.