Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study)

Young Min Cho, Chaicharn Deerochanawong, Samroeng Seekaew, Swangjit Suraamornkul, Sunun Benjachareonwong, Sarinya Sattanon, Parinya Chamnan, Thanitha Sirirak, Natapong Kosachunhanun, Thongchai Pratipanawatr, Sompongse Suwanwalaikorn, Woo Je Lee, Sungrae Kim, Seonghui Choi, Eun Seok Kang, Taekeun Oh, Sam Kwon, Moon Kyu Lee

Research output: Contribution to journalArticle

Abstract

The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two-week run-in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add-on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between-group mean difference, −0.7% [95% CI, −0.9% to −0.4%]; P-value < 0.0001). The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups. Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.

Original languageEnglish
Pages (from-to)123-127
Number of pages5
JournalDiabetes, Obesity and Metabolism
Volume22
Issue number1
DOIs
StatePublished - 1 Jan 2020

Keywords

  • dipeptidyl peptidase-4
  • gemigliptin
  • insulin
  • type 2 diabetes mellitus

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    Cho, Y. M., Deerochanawong, C., Seekaew, S., Suraamornkul, S., Benjachareonwong, S., Sattanon, S., Chamnan, P., Sirirak, T., Kosachunhanun, N., Pratipanawatr, T., Suwanwalaikorn, S., Lee, W. J., Kim, S., Choi, S., Kang, E. S., Oh, T., Kwon, S., & Lee, M. K. (2020). Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study). Diabetes, Obesity and Metabolism, 22(1), 123-127. https://doi.org/10.1111/dom.13873