Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise
- Authors
- Park, Juri; Park, Sung Woo; Yoon, Kun Ho; Kim, Sung Rae; Ahn, Kyu Jeung; Lee, Jae Hyuk; Mok, Ji Oh; Chung, Choon Hee; Han, Kyung Ah; Koh, Gwan Pyo; Kang, Jun Goo; Lee, Chang Beom; Kim, Seong Hwan; Kwon, Na Young; Kim, Doo Man
- Issue Date
- Dec-2017
- Publisher
- Blackwell Publishing Inc.
- Keywords
- antidiabetic drug; clinical trial; DPP-4 inhibitor; phase III study; type 2 diabetes
- Citation
- Diabetes, Obesity and Metabolism, v.19, no.12, pp 1681 - 1687
- Pages
- 7
- Journal Title
- Diabetes, Obesity and Metabolism
- Volume
- 19
- Number
- 12
- Start Page
- 1681
- End Page
- 1687
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/7027
- DOI
- 10.1111/dom.12987
- ISSN
- 1462-8902
1463-1326
- Abstract
- 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.
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