Safety and Efficacy of Sitagliptin compared with Glimepiride in Patients with Type 2 Diabetes Mellitus inadequately controlled with Metfromin Monotherapy

Abstract

Background: Type 2 diabetes mellitus (DM) is a life-long disease requiring chronic treatment and management. Therefore, assessment of the long-term safety and tolerability of newer therapeutic agents is of importance.
Objective: To compare safety and efficacy of sitagliptin with glimepiride in patients with type 2 diabetes mellitus not adequately controlled with metformin monotherapy.
Method: This study was conducted at Pharmacology Department, Gomal Medical College, Dera Ismail Khan from 1st June 2010 to 31st December 2012. Patients of type 2 DM not adequately controlled with a stable dose of metformin (≥ 1500 mg/day) monotherapy were randomized into 02 groups. One group was given sitagliptin 100mg while other group was given glimepiride 2mg once daily for 12 weeks. Primary end point of the study was number of patients achieving the target HbA1C <7%, while secondary end points were the reduction of HbA1C ,fasting blood sugar (FBS), change in weight from baseline and the safety profile of the two drugs.
Results: A total of 40 patients with history of type 2 DM not adequately controlled with metformin monotherapy were randomized into two groups, one group received sitagliptin while the other group was given glimepiride. Sitagliptin group consisted of 12(57%) males and 09(43%) females while glimepiride group consisted of 11(58%) males and 08(42%) females. Mean age of patients in sitagliptin group and glimepiride group was 48.5±8.2years and 48.8±10.3years. Primary end point was achieved in 57.1% patients in sitagliptin group and 52.6% patients in glimepiride group. There was no statistical significant difference between the two groups. HbA1C was reduced more in sitagliptin group (-1.04±0.2%) as compared to glimepiride group (-0.96±0.3) from baseline. Both groups caused the reduction in FBS. Sitagliptin caused reduction in weight while in glimepiride group there was slight increase in weight (-2.7±2.23kg vs. +2.45±0.55kg, p=0.002). Both the groups were well tolerated with no occurrence of serious side effects.
Conclusion: Sitagliptin, a DDP-4 antagonist is as efficacious as glimepiride in reducing HbA1C and fasting blood sugar. It also causes reduction in weight and is well tolerated.