Aims: To evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise. Materials and Methods: In this randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to week 24. Results: The mean baseline HbA1c levels were similar in the evogliptin and the placebo groups (7.20% ± 0.56% vs 7.20% ± 0.63%, respectively). At week 24, evogliptin significantly reduced HbA1c levels from baseline compared with placebo (−0.23% vs 0.05%, respectively, P <.0001). Additionally, the proportion of patients achieving HbA1c <6.5% was significantly higher in the evogliptin group than in the placebo group (33.3% vs 15.2%; P =.008). The overall incidence of adverse events, including hypoglycaemia, was similar in the 2 groups. Conclusions: In this 24-week study, once-daily evogliptin monotherapy significantly improved glycaemic control and was well tolerated in patients with T2D.
Bibliographical noteFunding Information:
This study was supported by Dong-A ST Co., Ltd, Seoul, Korea
This study was supported by Dong-A ST Co., Ltd, Seoul, Korea. The sponsor participated in the study design, data collection and analysis of the data, but had no role in the writing of the manuscript or in the decision to submit the manuscript for publication. We sincerely thank Seung Sik Hwang, MD, PhD (Professor, Department of Public Health Sciences, Seoul National University) and Jin-Young Jeong, PhD (Professor, Department of Social and Preventive Medicine, Hallym University College of Medicine) for their valuable guidance and assistance in the statistical analysis and writing. N. Y. Kwon is an employee of Dong-A ST Co., Ltd. The other authors have no conflicts of interest related to this work. S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn and D. M. Kim designed the study; J. Park, S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn, J. H. Lee, J. O. Mok, C. H. Chung, K. A. Han, G. P. Koh, J. G. Kang, C.B. Lee and D. M. Kim performed the study; J. Park, N. Y. Kwon and D. M. Kim analyzed the data; J. Park, S. H. Kim and D. M. Kim drafted and finalized the full manuscript.
© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism