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Efficacy and safety of gemigliptin, a dipeptidyl peptidase‐4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24‐week, multicentre, randomized, double‐blind, placebo‐controlled study ( TROICA study)
Author(s) -
Ahn Chang Ho,
Han Kyung Ah,
Yu Jae Myung,
Nam Joo Young,
Ahn Kyu Jeung,
Oh Tae Keun,
Lee Hyoung Woo,
Lee Dae Ho,
Kim Jaetaek,
Chung Choon Hee,
Park Tae Sun,
Kim Byung Joon,
Park Seok Won,
Park Hyeong Kyu,
Lee Kwang Jae,
Kim SangWook,
Park Jeong Hyun,
Ko Kwan Pyo,
Kim Chong Hwa,
Lee Hyunjin,
Jang Hak Chul,
Park Kyong Soo
Publication year - 2017
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.12866
Subject(s) - metformin , glimepiride , medicine , placebo , type 2 diabetes , endocrinology , diabetes mellitus , randomized controlled trial , clinical endpoint , gastroenterology , alternative medicine , pathology
Aims To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase‐4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes ( T2DM ). Materials and methods We conducted a randomized, double‐blind, placebo‐controlled trial in 219 K orean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin ( HbA1c ) level from baseline to week 24. Results The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between‐group difference in adjusted mean change −0.87%, 95% confidence interval [ CI ] −1.09% to −0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (−0.93 mmol/ L , 95% CI −1.50 to −0.35 mmol/ L ), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (−0.21 mmol/ L , 95% CI −0.38 to −0.03 mmol/ L for total cholesterol, −0.18 mmol/ L , 95% CI −0.34 to −0.01 mmol/ L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group. Conclusions Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.