|
KMID : 1200020230470060796
|
|
Diabetes & Metabolism Journal
2023 Volume.47 No. 6 p.796 ~ p.807
|
|
|
Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial
|
|
Han Kyung-Ah
Kim Yong-Hyun
Kim Doo-Man
Lee Byung-Wan
Chon Suk
Sohn Tae-Seo
Jeong In-Kyung
Hong Eun-Gyoung
Son Jang-Won
Nah Jae-Jin
Song Hwa-Rang
Cho Seong-In
Cho Seung-Ah
Yoon Kun-Ho
|
|
|
Abstract
|
|
|
Background : Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes mellitus (T2DM) against dapagliflozin.
Methods : In this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n=101) or dapagliflozin 10 mg/day (n=99) in addition to ongoing metformin therapy for 24 weeks. The primary objective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500).
Results : Adjusted mean change of HbA1c at week 24 was ?0.80% with enavogliflozin and ?0.75% with dapagliflozin (difference, ?0.04%; 95% confidence interval, ?0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respectively. Adjusted mean change of fasting plasma glucose at week 24 was ?32.53 and ?29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P<0.0001) and decrease in homeostasis model assessment of insulin resistance (?1.85 vs. ?1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (?3.77 kg vs. ?3.58 kg) and blood pressure (systolic/diastolic, ?5.93/?5.41 mm Hg vs. ?6.57/?4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated.
Conclusion : Enavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic control on metformin alone.
|
|
|
KEYWORD
|
|
|
Dapagliflozin, Diabetes mellitus, type 2, Hypoglycemic agents, Metformin, Randomized controlled trial, Sodium-glucose transporter 2 inhibitors
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|