Efficacy and safety of adding evogliptin versus sitagliptin for metformin‐treated patients with type 2 diabetes: A 24‐week randomized, controlled trial with open label extension

AIMS: This trial consisted of a 24‐week multicentre, randomized, double‐blind, double‐dummy, active‐controlled study and a 52‐week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase‐4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. METHODS: Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (≥1000 mg/d) were randomized 1:1 to add‐on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non‐inferiority was concluded if the upper limit of the 2‐sided 95% confidence interval for the HbA1c difference between treatments was <0.35%. RESULTS: Mean changes in HbA1c following addition of evogliptin or sitagliptin were −0.59% and −0.65%, respectively. The between‐group difference was 0.06% (2‐sided 95% confidence interval, −0.10 to 0.22), demonstrating non‐inferiority. After the 52‐week treatment, evogliptin caused a persistently decreased level of HbA1c (−0.44% ± 0.65%, P < .0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks. CONCLUSIONS: Evogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non‐inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.