Aims: This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. Methods: Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (≥1000 mg/d) were randomized 1:1 to add-on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%. Results: Mean changes in HbA1c following addition of evogliptin or sitagliptin were −0.59% and −0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, −0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (−0.44% ± 0.65%, P <.0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks. Conclusions: Evogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non-inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.
Bibliographical noteFunding Information:
We thank the other investigators for their cooperation in this study. The full list of other investigators is as follows: J. G. Kang (Hallym University Sacred Heart Hospital, Hallym University School of Medicine, Gyeonggi-do, Republic of Korea), G. P. Koh (Jeju National University School of Medicine, Jeju, Korea), D. M. Kim (Hallym University, Seoul, Republic of Korea), S. R. Kim (The Catholic University of Korea, Seoul, Korea), Y. S. Kim (Inha University School of Medicine, Incheon, Korea), K. Y. Park (College of Medicine, Konyang University, Daejeon, Korea), J-Y. Park (Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea), Y. A. Sung (Ewha Womans University School of Medicine, Seoul, Republic of Korea), K. H. Song (The Catholic University of Korea, Seoul, South Korea) K. J. Ahn (Kyung Hee University School of Medicine, Seoul, Republic of Korea), M. K. Lee (Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.), I.-K. Lee (Kyungpook National University School of Medicine Daegu, South Korea), J. H. Lee (Myongji Hosipital, Goyang, Republic of Korea), H. W. Lee (Yeungnam University, Daegu, Republic of Korea), S. Lim (Seoul National University Bundang Hospital, Seongnam, Korea), B. S. Cha (Yonsei University College of Medicine, Seoul, Korea), and K. M. Choi (Korea University, Seoul, Republic of Korea). Dong-Min Hwang is an employee of Dong-A ST Co., Ltd. The other authors have no conflicts of interest related to this work. Sang-Mo Hong, Cheol-Young Park, Kyung Ah Han, Chang Beom Lee, Choon Hee Chung, Kun-Ho Yoon, Ji-Oh Mok, Kyong Soo Park, and Sung-Woo Park designed and performed the clinical study; Sang-Mo Hong, Cheol-Young Park, Dong-Min Hwang, and Sung-Woo Park analyzed the data; Sang-Mo Hong, Cheol-Young Park and Sung-Woo Park drafted and finalized the full manuscript; Kyung Ah Han, Chang Beom Lee, Choon Hee Chung, Kun-Ho Yoon, Ji-Oh Mok, and Kyong Soo Park reviewed and revised the 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