We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean 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 (20mg) 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 24weeks. 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 -1.21mmol/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 24weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.
Bibliographical noteFunding Information:
This study was supported by Handok Inc., Seoul, Republic of Korea. We thank the other investigators for their cooperation with this study. The full list of investigators for this study is as follows: K-J. Ahn (Kyung Hee University Hospital at Gangdong, Seoul, Korea), K.-H. Song (Konkuk University Hospital, Seoul, Korea), D.-K. Kim (Dong-A University, College of Medicine, Busan, Korea), J.-H. Park (College of Medicine, Inje University, Busan, Korea), M.-Y. Jung (Chonnam National University Hospital, Gwangju, Korea), S.-W. Jeon (Soonchunhyang University College of Medicine, Cheonan, Korea), C.-S. Kim (HallymUniversity Pyungchon SacredHeartHospital, Anyang, Korea), Y.-D. Song (NationHealth Insurance Corporation Ilsan Hospital, Ilsan, Korea), J-H. Lee (Myongji Hospital, Goyang, Korea).
© 2016 John Wiley & Sons Ltd.
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism