Abstract

Background: Sitagliptin, an oral and selective dipeptidyl peptidase-4 inhibitor, represents a novel therapeutic approach for the treatment of type 2 diabetes mellitus. Metformin and glimepiride are most commonly used oral hypoglycemic agents.
Objective: To compare combination of metformin and glimepiride with that of metformin and sitagliptin in patients with type 2 diabetes mellitus.
Materials and Methods: The study was conducted by Department of Pharmacology, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India, in Medicine OPD for 1 year. Total 60 patients with type 2 diabetes mellitus were included in the study. The patients were divided into two groups: Group I (n = 30), patients were put on metformin 500 mg + glimepiride 1 mg once daily and Group II, (n = 30), patients were put on metformin 500 + sitagliptin 50 mg once daily. The patients were stabilized for 2 weeks and followed up every 6 weeks for 24 weeks. Fasting blood sugar (FBS) and postprandial blood sugar (PPBS) were measured at every follow-up; glycosylated hemoglobin (HbA1c) was measured at 0 and 24 weeks. Analysis was done using t-test, and a p-value of <0.05 was considered significant.
Results: The patients with type 2 diabetes mellitus having a mean age of 52.95 ± 0.95 years and mean duration of diabetes mellitus of 6.62 ±0.53 years were included in the study. Positive family history of diabetes mellitus was seen in 22 (36.67%) patients. FBS in groups I and II at 0 and 24 weeks was 164.4 ± 5.09 and 127.30 ± 2.31 mg/dl (p < 0.001) and 167.30 ± 5.69 and 125.16 ± 2.48 mg/dl (p < 0.001), respectively. PPBS in groups I and II at 0 and 24 weeks was 209.90 ± 8.29 and 160.83 ± 4.40 mg/dl (p < 0.001) and 214.53 ± 5.64 and 156.93 ± 2.10 (p < 0.001), respectively. HbA1c in group I at 0 and 24 weeks was 8.79 ± 0.11 and 7.32 ± 0.11% (p < 0.001) and in group II was 8.98 ± 0.13 and 7.09 ± 0.13% (p < 0.001), respectively. At 24 weeks, intergroup comparison in FBS (p > 0.05), PPBS (p < 0.05), and HbA1c (p > 0.05) was done. Most common adverse drug reactions were hypoglycemia, abdominal discomfort, weight loss, and nausea/vomiting. Conclusion: Both groups showed significant improvement in FBS, PPBS, and HbA1c at the end of the study period. Intergroup comparison showed significant improvement in PPG in group II (with a combination of metformin and sitagliptin) at the end of the study.