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We assessed the 24‐week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase‐4 inhibitor, in  K orean patients with type 2 diabetes mellitus ( T2DM ) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double‐blind, placebo‐controlled, parallel‐group, phase  III  study. Patients (n = 142) were randomized 2 : 1 into two different treatment groups as follows: 99 received teneligliptin (20 mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin ( HbA1c ) level from baseline to week 24. Teneligliptin significantly reduced the  HbA1c  level from baseline compared with placebo after 24 weeks. At week 24, the differences between changes in  HbA1c  and fasting plasma glucose ( FBG ) in the teneligliptin and placebo groups were −0.94% [least‐squares ( LS ) mean −1.22, −0.65] and −1.21 mmol/l (−1.72, −0.70), respectively (all p < 0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase  III , randomized, placebo‐controlled study provides evidence of the safety and efficacy of 24 weeks of treatment with teneligliptin as a monotherapy in  K orean patients with  T2DM .

diabetes, obesity and metabolism

Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase‐4 inhibitor, in  K orean patients with type 2 diabetes mellitus: a 24‐week multicentre, randomized, double‐blind, placebo‐controlled phase  III  trial