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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)
Author(s) -
Cho Young Min,
Deerochanawong Chaicharn,
Seekaew Samroeng,
Suraamornkul Swangjit,
Benjachareonwong Sunun,
Satta Sarinya,
Chamnan Parinya,
Sirirak Thanitha,
Kosachunhanun Natapong,
Pratipanawatr Thongchai,
Suwanwalaikorn Sompongse,
Lee Woo Je,
Kim Sungrae,
Choi Seonghui,
Kang Eun Seok,
Oh Taekeun,
Kwon Sam,
Lee MoonKyu
Publication year - 2020
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13873
Subject(s) - metformin , medicine , insulin , placebo , adverse effect , diabetes mellitus , type 2 diabetes , clinical endpoint , type 2 diabetes mellitus , endocrinology , randomized controlled trial , alternative medicine , pathology
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.