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Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase‐4 inhibitor, in K orean patients with type 2 diabetes mellitus: a 24‐week multicentre, randomized, double‐blind, placebo‐controlled phase III trial
Author(s) -
Hong S.,
Park C.Y.,
Han K. A.,
Chung C. H.,
Ku B. J.,
Jang H. C.,
Ahn C. W.,
Lee M.K.,
Moon M. K.,
Son H. S.,
Lee C. B.,
Cho Y.W.,
Park S.W.
Publication year - 2016
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12631
Subject(s) - placebo , dipeptidyl peptidase 4 inhibitor , medicine , clinical endpoint , randomized controlled trial , adverse effect , type 2 diabetes mellitus , gastroenterology , placebo controlled study , diabetes mellitus , type 2 diabetes , glycated hemoglobin , dipeptidyl peptidase 4 , double blind , pharmacology , endocrinology , alternative medicine , pathology
We assessed the 24‐week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase‐4 inhibitor, in K orean 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 24 weeks. 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 24 weeks of treatment with teneligliptin as a monotherapy in K orean patients with T2DM .