SAFETY AND EFFICACY OF SITAGLIPTIN COMPARED WITH GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY

Background: Type 2 diabetes mellitus (DM) is a chronic disease requiring lifelong treatment. Therefore, assessment of the long-term safety and tolerability of newer therapeutic agents is of importance. The objective of this study was to compare safety and efficacy of sitagliptin with glimepiride in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Material Methods: Patients with type 2 DM inadequately controlled with metformin monotherapy were randomized to receive sitagliptin 100mg or glimepiride 2mg once daily as add-on therapy for 12 weeks. Primary end point was the number of patients achieving HbA1C 7%, while secondary end points were change in HbA1C, fasting blood sugar (FBS) and weight from baseline and the safety profile of the two drugs. Results: A total of 40 patients with type 2 DM inadequately controlled with metformin monotherapy were randomized to recieve sitagliptin or glimepiride as add-on therapy. There were 21 patients in sitagliptin group and 19 patients in glimepiride group. Primary end point was reached in 57% patients in sitagliptin group and 52.6% patients in glimepiride group, p=0.68. HbA1C was reduced more in sitagliptin group (-1.04±0.2%) as compared to glimepiride group (-0.96±0.3). Both groups caused the reduction in FBS. Sitagliptin caused reduction in weight while in glimepiride group there was increase in weight (-2.7±2.2kg vs. +2.5±0.6kg, p=0.002). Both the drugs were well tolerated with no serious side effects. Conclusion: Sitagliptin is as efficacious as glimepiride in reducing HbA1C and fasting blood sugar. It also causes reduction in weight and is well tolerated