Comparison of the effects of gemigliptin and dapagliflozin on glycaemic variability in type 2 diabetes: A randomized, open‐label, active‐controlled, 12‐week study (STABLE II study)

Aims The aim of this study was to compare the effect of gemigliptin, a dipeptidyl peptidase‐4 inhibitor, and dapagliflozin, a sodium glucose co‐transporter‐2 inhibitor, on glycaemic variability in type 2 diabetes patients. Materials and methods In this randomized, blinded end point, multicentre clinical trial, we enrolled 71 patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve. The participants were randomized to receive gemigliptin 50 mg (n = 35) or dapagliflozin 10 mg (n = 36) daily for 12 weeks. Glycaemic variability was estimated by mean amplitude of glycaemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) using a 6‐day continuous glucose monitoring system. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline. Results Intergroup differences in baseline characteristics were not significant. The adjusted mean change (± standard error) in MAGE after 12 weeks in the gemigliptin and dapagliflozin groups was −27.2 ± 4.4 mg/dL and −7.9 ± 4.9 mg/dL, respectively. Between‐group comparisons showed a significantly larger reduction in MAGE in the gemigliptin group (−19.2 mg/dL; 95% CI, −31.3 to −7.2; P = .002). Measures of SD and CV also showed a significantly larger reduction in the gemigliptin group. Average glycaemic control, estimated by HbA1c, fasting glucose and safety profiles, was comparable between the two groups. Conclusions Compared to dapagliflozin, gemigliptin significantly improved glycaemic variability, with similar glucose‐lowering efficacy and safety profiles in patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve.