Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study
- Authors
- Kim, Kyung-Soo; Han, Kyung Ah; Kim, Tae Nyun; Park, Cheol-Young; Park, Jung Hwan; Kim, Sang Yong; Kim, Yong Hyun; Song, Kee Ho; Kang, Eun Seok; Kim, Chul Sik; Koh, Gwanpyo; Kang, Jun Goo; Kim, Mi Kyung; Han, Ji Min; Kim, Nan Hee; Mok, Ji Oh; Lee, Jae Hyuk; Lim, Soo; Kim, Sang Soo; Kim, Tae Ho; Won, Kyu Chang; Lee, Ki Young; Cho, Jae Hyoung; Han, Ju Young; Kim, So Hun; Nah, Jae Jin; Song, Hwa Rang; Lee, Si Eun; Kim, Sungrae
- Issue Date
- Jul-2023
- Publisher
- Elsevier Masson
- Keywords
- Enavogliflozin; HbA1c; Phase III study; Randomized controlled study; Sodium-glucose cotransporter 2 inhibitor; Type 2 diabetes mellitus
- Citation
- Diabetes and Metabolism, v.49, no.4
- Journal Title
- Diabetes and Metabolism
- Volume
- 49
- Number
- 4
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/22470
- DOI
- 10.1016/j.diabet.2023.101440
- ISSN
- 1262-3636
1878-1780
- Abstract
- Aims: This study evaluated the efficacy and safety of enavogliflozin, a novel sodium-glucose cotransporter 2 inhibitor, versus dapagliflozin in Korean patients with type 2 diabetes mellitus (T2DM) inadequately con-trolled with metformin and gemigliptin. Methods: In this multicenter, double-blind, randomized study, patients with inadequate response to metfor-min (>= 1000 mg/day) plus gemigliptin (50 mg/day) were randomized to receive enavogliflozin 0.3 mg/day (n = 134) or dapagliflozin 10 mg/day (n = 136) in addition to the metformin plus gemigliptin therapy. The pri-mary endpoint was change in HbA1c from baseline to week 24.Results: Both treatments significantly reduced HbA1c at week 24 (-0.92% in enavogliflozin group, -0.86% in dapagliflozin group). The enavogliflozin and dapagliflozin groups did not differ in terms of changes in HbA1c (between-group difference: -0.06%, 95% confidence interval [CI]: -0.19, 0.06) and fasting plasma glucose (between-group difference: -3.49 mg/dl [-8.08;1.10]). An increase in urine glucose-creatinine ratio was sig-nificantly greater in the enavogliflozin group than in the dapagliflozin group (60.2 g/g versus 43.5 g/g, P < 0.0001). The incidence of treatment-emergent adverse events was similar between the groups (21.64% ver-sus 23.53%).Conclusions: Enavogliflozin, added to metformin plus gemigliptin, was well tolerated and as effective as dapa-gliflozin in the treatment of patients with T2DM.(c) 2023 The Author(s). Published by Elsevier Masson SAS. This is an open access article under the CC BY-NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
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