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

Juri Park, Sung Woo Park, Kun Ho Yoon, Sung Rae Kim, Kyu Jeung Ahn, Jae Hyuk Lee, Ji Oh Mok, Choon Hee Chung, Kyung Ah Han, Gwan Pyo Koh, Jun Goo Kang, Chang Beom Lee, Seong Hwan Kim, Na Young Kwon, Doo Man Kim

Research output: Contribution to journalArticle

4 Citations (Scopus)

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 languageEnglish
Pages (from-to)1681-1687
Number of pages7
JournalDiabetes, Obesity and Metabolism
Volume19
Issue number12
DOIs
Publication statusPublished - 2017 Dec 1

Fingerprint

Glycosylated Hemoglobin A
Type 2 Diabetes Mellitus
Exercise
Diet
Safety
Placebos
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemia
4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one
Incidence

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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. / Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise. In: Diabetes, Obesity and Metabolism. 2017 ; Vol. 19, No. 12. pp. 1681-1687.
@article{2ea89897deef4fc8a68b5811ace5fc79,
title = "Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise",
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.",
author = "Juri Park and Park, {Sung Woo} and Yoon, {Kun Ho} and Kim, {Sung Rae} and Ahn, {Kyu Jeung} and Lee, {Jae Hyuk} and Mok, {Ji Oh} and Chung, {Choon Hee} and Han, {Kyung Ah} and Koh, {Gwan Pyo} and Kang, {Jun Goo} and Lee, {Chang Beom} and Kim, {Seong Hwan} and Kwon, {Na Young} and Kim, {Doo Man}",
year = "2017",
month = "12",
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doi = "10.1111/dom.12987",
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Park, J, Park, SW, Yoon, KH, Kim, SR, Ahn, KJ, Lee, JH, Mok, JO, Chung, CH, Han, KA, Koh, GP, Kang, JG, Lee, CB, Kim, SH, Kwon, NY & Kim, DM 2017, 'Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise', Diabetes, Obesity and Metabolism, vol. 19, no. 12, pp. 1681-1687. https://doi.org/10.1111/dom.12987

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, 01.12.2017, p. 1681-1687.

Research output: Contribution to journalArticle

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 - 2017/12/1

Y1 - 2017/12/1

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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