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Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes: a 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial

Title
Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes: a 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial
Author
이창범
Keywords
antidiabetic drug; DPP-IV inhibitor; phase III study; type 2 diabetes
Issue Date
2016-05
Publisher
Wiley-Blackwell
Citation
Diabetes, Obesity and Metabolism, v. 18, no. 5, Page. 528-532
Abstract
We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n = 142) were randomized 2 : 1 into two different treatment groups as follows: 99 received teneligliptin (20 mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21 mmol/l (-1.72, -0.70), respectively (all p < 0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.
URI
https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.12631http://repository.hanyang.ac.kr/handle/20.500.11754/71500
ISSN
1462-8902; 1463-1326
DOI
10.1111/dom.12631
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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