학술논문

Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.
Document Type
Article
Source
Diabetes, Obesity & Metabolism. Dec2017, Vol. 19 Issue 12, p1681-1687. 7p.
Subject
*TYPE 2 diabetes treatment
*HYPOGLYCEMIC agents
*GLYCOSYLATED hemoglobin
*DIET
*EXERCISE physiology
*CD26 antigen
Language
ISSN
1462-8902
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. [ABSTRACT FROM AUTHOR]