Evaluation of the efficacy, safety and tolerability of miglitol in adult Indian patients with uncomplicated type 2 diabetes mellitus.

Postprandial hyperglycaemia and spikes have deleterious effects on Insulin secretion and sensitivity. The present study was undertaken to evaluate the efficacy, safety and tolerability of miglitol 50 mg three times daily for 12 weeks in 129 patients with type 2 diabetes mellitus, inadequately managed with diet and exercise therapy alone for 3 months after obtaining their written informed consent. The primary efficacy variables were per cent change from baseline at week 12 in fasting and postprandial plasma glucose concentrations and glycosylated haemoglobin (HbA(1C)) levels. After treatment at the end of 12 weeks mean reduction in fasting plasma glucose levels was 35.7% and 44.33% in postprandial plasma glucose levels while the mean HbA(1C) was significantly reduced by 0.88% (p<0.05). Total cholesterol, HDL, LDL and TC/HDL ratio did not showed any significant change but a non-significant reduction in triglyceride levels was observed in some patients. The mean body mass index was reduced non-significantly by 8% from baseline values. A total 19.5% patients treated with miglitol reported adverse events like flatulence, abdominal pain, nausea/vomiting, diarrhoea and dyspepsia. Only one patient reported hypoglycaemia. The results of the present study indicate that miglitol reduces fasting and postprandial plasma glucose levels, Improving glycaemic control, which is reflected in a reduced HbA(1C) level in patients with type 2 diabetes mellitus. It could be a useful first-line therapy in patients with type 2 diabetes mellitus inadequately controlled by diet alone and as adjuvant therapy in patients who are inadequately controlled with diet and sulfonylureas.

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.

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.