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

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6 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

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Keywords

  • antidiabetic drug
  • clinical trial
  • DPP-4 inhibitor
  • phase III study
  • type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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