Evaluation of safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus: Analytical study
Dr. Manju Kumari, Dr. Rohit kumar Singh
Aim: To evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM). Methods: This prospective analytical study was carried out in the Department of Pharmacology at Anugrah Narayan Magadh Medical College and Hospital, Gaya, Bihar from November 2019 to May 2020. A total of 300 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 190) or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 110) for 15 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c). Secondary endpoints were change in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body mass index (BMI) and to assess overall safety profile. Results: At 15 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.39%) as compared to sitagliptin group (0.31%) (P = 0.001). Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group (P = 0.007). There was no significant difference in terms of change in BMI (0.09±0.43kg/m2 vs. 0.11±0.34kg/m2) in glimepiride and sitagliptin groups, respectively, (P = 0.611) between both the groups. The incidences of hypoglycemic events were also comparable among both the groups. Conclusion: In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycaemia.