Safety and Efficacy of Fixed Dose Combination of Voglibose, Glimepiride and Metformin in Indian Type 2 Diabetes Mellitus Patients

摘要

Worldwide diabetes mellitus is highly prevalent and economically devastating illness. This study was a post marketing surveillance (PMS), non-randomized, open, non-comparative, mono-centric study. The drug administered was a fixed dose combination of voglibose 0.2 mg; glimepiride ? mg and metformin 500 mg sustained release (SR). Fifty type 2 diabetic patients were given fixed dose combination twice daily with major meals for 3 months. Baseline value was recorded for glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and post prandial blood glucose/hyperglycemia (PPHG) level. There was significant decrease from baseline in HBA1c value 10.6 ± 1.3 vs. 6.6 ± 0.4 (P< 0.0001), FPG levels 208.33 mg/dl vs. 118.06 (P< 0.0001), and PPHG levels 360.14 mg/dl vs. 168.36, (P< 0.0001) after 3 months of treatment. The combination was found to be effective in controlling both fasting and post prandial glucose level and was well tolerated. Investigator commented that the use of triple drug combination is a good option in the management of type 2 diabetes which controls both fasting as well as post prandial blood glucose and ultimately HbA1c values.