Effect of short‐term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug‐naïve Japanese patients with type 2 diabetes mellitus

Aims To compare the effect of a dipeptidyl peptidase‐4 inhibitor (DPP4‐i) and a sulfonylurea (SU) on daily glucose fluctuation in drug‐naïve Japanese patients with type 2 diabetes mellitus (T2DM). Materials and methods A total of 53 drug‐naïve Japanese patients with T2DM (HbA1c, 7.0%‐9.0%; fasting plasma glucose, 6.1 mmol/L or higher) were randomly assigned to either sitagliptin 50 mg qd or glibenclamide 2.5 mg per day (given in divided doses) in a 1:1 ratio. A continuous glucose monitoring (CGM) device was used to obtain 24‐hour glucose profiles for each patient at baseline and at Week 2. The primary study endpoint was change from baseline in mean amplitude of glucose excursion (MAGE) during a 24‐hour period. A key secondary endpoint was change from baseline in the standard deviation (SD) of 24‐hour glucose levels. Results After 2 weeks of treatment, a numerically greater reduction in MAGE from baseline was observed in the sitagliptin group compared with the glibenclamide group, but the between‐treatment difference was not statistically significant (LS mean difference [95% CI]: –0.48 mmol/L [−1.31, 0.34]; P = .245). However, a significantly greater reduction in the change from baseline in SD was observed in the sitagliptin group compared with the glibenclamide group (LS mean difference [95% CI]: –0.33 mmol/L [−0.62, −0.03]; P = .029). Conclusions This study suggests that the DPP4 inhibitor sitagliptin has a greater ability to reduce daily glucose fluctuation than the SU glibenclamide in drug‐naïve Japanese patients with T2DM. ClinicalTrials.gov : NCT02318693