Effects of once‐daily teneligliptin on 24‐h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4‐week, randomized, double‐blind, placebo‐controlled trial

Abstract

Abstract Aim To assess blood glucose control over 24 h and the safety of teneligliptin 10 and 20 mg, a novel dipeptidyl peptidase‐4 inhibitor, in Japanese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Methods Ninety‐nine patients were administered teneligliptin 10 or 20 mg or placebo before breakfast for 4 weeks in a randomized, double‐blind, placebo‐controlled, parallel‐group study. Results Both teneligliptin‐treated groups showed significantly smaller 2‐h postprandial glucose (2‐h PPG ), 24‐h mean glucose and fasting plasma glucose values than the placebo group. The differences between the teneligliptin 10 mg and placebo groups in changes in 2‐h PPG after each meal were −50.7 ± 7.8, −34.8 ± 9.2 and −37.5 ± 7.5 mg/ dl at breakfast, lunch and dinner, respectively [least‐squares ( LS ) means ± standard error ( s.e .), all, p < 0.001]. The corresponding LS means ± s.e . for teneligliptin 20 mg versus placebo were −38.1 ± 7.8, −28.6 ± 9.2 and −36.1 ± 7.5 mg/ dl , respectively (p < 0.001, p < 0.01, p < 0.001, respectively). Both doses of teneligliptin increased postprandial plasma active glucagon‐like peptide‐1 concentrations compared with placebo. The incidence of adverse events and drug‐related adverse events was similar among groups. There were no hypoglycaemic symptoms or serious adverse events. Conclusions Once‐daily teneligliptin improved blood glucose levels over 24 h without hypoglycaemia.