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

doi: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

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

Internal Medicine

Research output: Contribution to journal › Article › peer-review

16 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 language	English
Pages (from-to)	1681-1687
Number of pages	7
Journal	Diabetes, Obesity and Metabolism
Volume	19
Issue number	12
DOIs	https://doi.org/10.1111/dom.12987
Publication status	Published - 2017 Dec

Bibliographical note

Funding Information:
This study was supported by Dong-A ST Co., Ltd, Seoul, Korea

Funding Information:
This study was supported by Dong-A ST Co., Ltd, Seoul, Korea. The sponsor participated in the study design, data collection and analysis of the data, but had no role in the writing of the manuscript or in the decision to submit the manuscript for publication. We sincerely thank Seung Sik Hwang, MD, PhD (Professor, Department of Public Health Sciences, Seoul National University) and Jin-Young Jeong, PhD (Professor, Department of Social and Preventive Medicine, Hallym University College of Medicine) for their valuable guidance and assistance in the statistical analysis and writing. N. Y. Kwon is an employee of Dong-A ST Co., Ltd. The other authors have no conflicts of interest related to this work. S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn and D. M. Kim designed the study; J. Park, S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn, J. H. Lee, J. O. Mok, C. H. Chung, K. A. Han, G. P. Koh, J. G. Kang, C.B. Lee and D. M. Kim performed the study; J. Park, N. Y. Kwon and D. M. Kim analyzed the data; J. Park, S. H. Kim and D. M. Kim drafted and finalized the full manuscript.

Publisher Copyright:
© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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Internal Medicine
Endocrinology, Diabetes and Metabolism
Endocrinology

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10.1111/dom.12987

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Park, J., Park, S. W., Yoon, K. H., Kim, S. R., Ahn, K. J., Lee, J. H., Mok, J. O., Chung, C. H., Han, K. A., Koh, G. P., Kang, J. G., Lee, C. B., Kim, S. H., Kwon, N. Y., & Kim, D. M. (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, 19(12), 1681-1687. https://doi.org/10.1111/dom.12987

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}",

note = "Funding Information: This study was supported by Dong-A ST Co., Ltd, Seoul, Korea Funding Information: This study was supported by Dong-A ST Co., Ltd, Seoul, Korea. The sponsor participated in the study design, data collection and analysis of the data, but had no role in the writing of the manuscript or in the decision to submit the manuscript for publication. We sincerely thank Seung Sik Hwang, MD, PhD (Professor, Department of Public Health Sciences, Seoul National University) and Jin-Young Jeong, PhD (Professor, Department of Social and Preventive Medicine, Hallym University College of Medicine) for their valuable guidance and assistance in the statistical analysis and writing. N. Y. Kwon is an employee of Dong-A ST Co., Ltd. The other authors have no conflicts of interest related to this work. S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn and D. M. Kim designed the study; J. Park, S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn, J. H. Lee, J. O. Mok, C. H. Chung, K. A. Han, G. P. Koh, J. G. Kang, C.B. Lee and D. M. Kim performed the study; J. Park, N. Y. Kwon and D. M. Kim analyzed the data; J. Park, S. H. Kim and D. M. Kim drafted and finalized the full manuscript. Publisher Copyright: {\textcopyright} 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.",

year = "2017",

month = dec,

doi = "10.1111/dom.12987",

language = "English",

volume = "19",

pages = "1681--1687",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley-Blackwell",

number = "12",

}

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, 12.2017, p. 1681-1687.

Research output: Contribution to journal › Article › peer-review

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

N1 - Funding Information: This study was supported by Dong-A ST Co., Ltd, Seoul, Korea Funding Information: This study was supported by Dong-A ST Co., Ltd, Seoul, Korea. The sponsor participated in the study design, data collection and analysis of the data, but had no role in the writing of the manuscript or in the decision to submit the manuscript for publication. We sincerely thank Seung Sik Hwang, MD, PhD (Professor, Department of Public Health Sciences, Seoul National University) and Jin-Young Jeong, PhD (Professor, Department of Social and Preventive Medicine, Hallym University College of Medicine) for their valuable guidance and assistance in the statistical analysis and writing. N. Y. Kwon is an employee of Dong-A ST Co., Ltd. The other authors have no conflicts of interest related to this work. S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn and D. M. Kim designed the study; J. Park, S. W. Park, K. H. Yoon, S. R. Kim, K. J. Ahn, J. H. Lee, J. O. Mok, C. H. Chung, K. A. Han, G. P. Koh, J. G. Kang, C.B. Lee and D. M. Kim performed the study; J. Park, N. Y. Kwon and D. M. Kim analyzed the data; J. Park, S. H. Kim and D. M. Kim drafted and finalized the full manuscript. Publisher Copyright: © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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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JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

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ER -

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

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