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). Issue 5 (17th February 2017)

• Record Type: Journal Article
• Authors: 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, Sang‐Wook; Park, Jeong Hyun; Ko, Kwan Pyo; Kim, Chong Hwa; Lee, Hyunjin; Jang, Hak Chul; Park, Kyong Soo
• Is Part Of: Diabetes, obesity & metabolism. Volume 19:Issue 5(2017)
• Page Start: 635
• Page End: 643
• Publication Date: 2017-02-17
• Subjects: clinical trial -- DPP‐4 inhibitor -- phase III study; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12866
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract : 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 Korean 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.