TY - JOUR
T1 - A 52-week efficacy and safety study of enavogliflozin versus dapagliflozin as an add-on to metformin in patients with type 2 diabetes mellitus
T2 - ENHANCE-M extension study
AU - Sohn, Tae Seo
AU - Han, Kyung Ah
AU - Kim, Yonghyun
AU - Lee, Byung Wan
AU - Chon, Suk
AU - Jeong, In Kyung
AU - Hong, Eun Gyoung
AU - Son, Jang Won
AU - Na, Jae Jin
AU - Cho, Jae Min
AU - In Cho, Seong
AU - Huh, Wan
AU - Yoon, Kun Ho
N1 - Publisher Copyright:
© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
PY - 2024/6
Y1 - 2024/6
N2 - Aim: To evaluate the long-term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus. Materials and Methods: After 24 weeks of a randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open-label extension period. Results: Eighty-two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28-week open-label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p <.0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p <.0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose-creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p <.0001). Conclusions: Enavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose-creatinine ratio.
AB - Aim: To evaluate the long-term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus. Materials and Methods: After 24 weeks of a randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open-label extension period. Results: Eighty-two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28-week open-label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p <.0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p <.0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose-creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p <.0001). Conclusions: Enavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose-creatinine ratio.
KW - dapagliflozin
KW - enavogliflozin
KW - hypoglycaemic agents
KW - metformin
KW - randomized controlled trial
KW - sodium-glucose transporter 2 inhibitors
KW - type 2 diabetes mellitus
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UR - http://www.scopus.com/inward/citedby.url?scp=85187163021&partnerID=8YFLogxK
U2 - 10.1111/dom.15537
DO - 10.1111/dom.15537
M3 - Article
C2 - 38456558
AN - SCOPUS:85187163021
SN - 1462-8902
VL - 26
SP - 2248
EP - 2256
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 6
ER -