Publication:

Comparative glycemic efficacy and safety of sitagliptin versus gliclazide in uncomplicated type 2 diabetes mellitus: a 6-month prospective study

Background Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder requiring effective glycemic control while minimizing adverse effects such as hypoglycemia. Sitagliptin and gliclazide are commonly used oral antidiabetic agents with different mechanisms of action and safety profiles, but comparative data in uncomplicated T2DM are limited.

Methods This prospective, open-label, observational cohort study was conducted from July 2024 to August 2025 in patients aged 18-70 years with uncomplicated T2DM. A total of 291 patients were included and allocated into two groups based on treating physician’s discretion. Group A received sitagliptin (100 mg once daily) and group B received gliclazide (30 mg once daily). Patients were followed for six months. Glycemic parameters including fasting blood glucose (FBG), postprandial blood glucose (PPBG), and glycated hemoglobin (HbA1c) were assessed at baseline, 3 months and 6 months. Adverse drug reactions were recorded. Intra-group comparisons were performed using paired t-tests and inter-group comparisons were analyzed using unpaired t-tests, with p<0.05 considered statistically significant.

Results Both groups showed significant reduction in FBG and PPBG over six months (p<0.05). At 6 months, FBG decreased from 162.3±18.5 to 138.2±14.7 mg/dl in the sitagliptin group and from 164.1±19.2 to 124.5±13.9 mg/dl in the gliclazide group (p<0.05). PPBG decreased from 248.6±26.4 to 198.7±20.3 mg/dl in the sitagliptin group and from 251.2±27.1 to 175.8±19.6 mg/dl in the gliclazide group (p<0.05). HbA1c reduction was greater in the gliclazide group (8.3±1.0 to 6.8±0.6) compared to the sitagliptin group (8.2±0.9 to 7.5±0.7) (p<0.01). The incidence of hypoglycemia was significantly lower in the sitagliptin group (2.05%) compared to the gliclazide group (8.28%) (p<0.05).

Conclusions Gliclazide provides superior glycemic control, whereas sitagliptin offers a better safety profile with a lower risk of hypoglycemia. Treatment should be individualized based on patient characteristics and clinical priorities.