Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.

Autor: Park J; Department of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea., Park SW; Department of Endocrinology and Metabolism, Division of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea., Yoon KH; Department of Endocrinology and Metabolism, Division of Internal Medicine, Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea., Kim SR; Department of Endocrinology and Metabolism, Division of Internal Medicine, Bucheon St. Mary's Hospital, Catholic University of Korea, Bucheon, Korea., Ahn KJ; Department of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Kyung Hee Hospital, Kyung Hee University School of Medicine, Seoul, Korea., Lee JH; Department of Endocrinology and Metabolism, Division of Internal Medicine, Myongji Hospital, Kwandong University College of Medicine, Koyang, Korea., Mok JO; Department of Endocrinology and Metabolism, Division of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea., Chung CH; Department of Endocrinology and Metabolism, Division of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea., Han KA; Department of Endocrinology and Metabolism, Division of Internal Medicine, Eulji University School of Medicine, Daejeon, Korea., Koh GP; Department of Endocrinology and Metabolism, Division of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea., Kang JG; Department of Endocrinology and Metabolism, Division of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea., Lee CB; Department of Endocrinology and Metabolism, Division of Internal Medicine, Hanyang University Guri Hospital, Hanyang University Medical School, Guri, Korea., Kim SH; Department of Cardiology, Division of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea., Kwon NY; Division of Biostatistics, Clinical Development Team, Dong-A ST Co., LTD., Seoul, Korea., Kim DM; Department of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2017 Dec; Vol. 19 (12), pp. 1681-1687. Date of Electronic Publication: 2017 Jul 07.
DOI: 10.1111/dom.12987
Abstrakt: 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.
(© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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