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The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in  K orean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin ( HbA1c ) 7.0–10.0%, on stable metformin ≥1000 mg/day] were randomized 2 : 1 to receive 20 mg teneligliptin plus metformin ( n  = 136) or placebo plus metformin ( n  = 68). The primary endpoint was the change in  HbA1c  levels from baseline to week 16. The mean baseline  HbA1c  was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in  HbA1c  and fasting plasma glucose levels were −0.78 % and −1.24 mmol/l (22.42 mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in  K orean patients with type 2 diabetes.

diabetes, obesity and metabolism

Efficacy and safety of teneligliptin, a dipeptidyl peptidase‐4 inhibitor, combined with metformin in  K orean patients with type 2 diabetes mellitus: a 16‐week, randomized, double‐blind, placebo‐controlled phase  III  trial