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.
| Original language | English |
|---|---|
| Pages (from-to) | 1681-1687 |
| Number of pages | 7 |
| Journal | Diabetes, Obesity and Metabolism |
| Volume | 19 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 2017 Dec |
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All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Endocrinology
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Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise. / 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.
In: Diabetes, Obesity and Metabolism, Vol. 19, No. 12, 12.2017, p. 1681-1687.Research output: Contribution to journal › Article
TY - JOUR
T1 - Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise
AU - Park, Juri
AU - Park, Sung Woo
AU - Yoon, Kun Ho
AU - Kim, Sung Rae
AU - Ahn, Kyu Jeung
AU - Lee, Jae Hyuk
AU - Mok, Ji Oh
AU - Chung, Choon Hee
AU - Han, Kyung Ah
AU - Koh, Gwan Pyo
AU - Kang, Jun Goo
AU - Lee, Chang Beom
AU - Kim, Seong Hwan
AU - Kwon, Na Young
AU - Kim, Doo Man
PY - 2017/12
Y1 - 2017/12
N2 - 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.
AB - 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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U2 - 10.1111/dom.12987
DO - 10.1111/dom.12987
M3 - Article
C2 - 28448688
AN - SCOPUS:85021855219
VL - 19
SP - 1681
EP - 1687
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 12
ER -