Lee Eun Young, Cho Jae-Hyoung, Lee Woo Je, Kim Nam Hoon, Kim Jae Hyeon, Lee Byung-Wan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Diabetes Res Clin Pract. 2023 Sep;203:110884. doi: 10.1016/j.diabres.2023.110884. Epub 2023 Aug 16.
To compare the effectiveness and safety of empagliflozin and dulaglutide in patients with type 2 diabetes (T2D) inadequately controlled by oral triple therapy.
In this 24-week, multi-center, randomized trial, patients with T2D and HbA level ≥7.5% (58 mmol/mol) on metformin, sulfonylurea, and dipeptidyl peptidase 4 inhibitor (DPP4-i) were randomly assigned into two groups: daily empagliflozin add-on or once-weekly dulaglutide switched from DPP4-i. The primary endpoint was changes from baseline HbA at 24 weeks.
In total, 152 patients were recruited to the empagliflozin-added quadruple group (n = 76) or the switched-to-dulaglutide triple group (n = 76). At week 24, both groups showed significant reduction in HbA1c level from baseline with greater reduction with empagliflozin (the mean treatment difference: -0.27% [95% CI -0.50 to -0.04, p = 0.024]) (-2.88 mmol/mol [95% CI -5.37 to -0.39], p = 0.024). Empagliflozin significantly reduced body weight from baseline to week 24 (-1.72 kg [95% CI -1.98 to -0.59, p < 0.001]). No serious adverse events were reported with either empagliflozin or dulaglutide.
Empagliflozin, compared with once-weekly dulaglutide switched from DPP4-i, demonstrated greater HbA reduction and weight loss in patients with T2D inadequately controlled with metformin, sulfonylurea, and DPP4-i.
cris.nih.go.kr (KCT0006157).
比较恩格列净和度拉糖肽在口服三联疗法血糖控制不佳的2型糖尿病（T2D）患者中的有效性和安全性。
在这项为期24周的多中心随机试验中，正在接受二甲双胍、磺脲类药物和二肽基肽酶4抑制剂（DPP4-i）治疗且糖化血红蛋白（HbA）水平≥7.5%（58 mmol/mol）的T2D患者被随机分为两组：每日加用恩格列净组或由DPP4-i转换为每周一次度拉糖肽组。主要终点是24周时HbA相对于基线的变化。
共有152例患者被纳入加用恩格列净的四联组（n = 76）或转换为度拉糖肽的三联组（n = 76）。在第24周时，两组的糖化血红蛋白（HbA1c）水平均较基线显著降低，恩格列净组降低幅度更大（平均治疗差异：-0.27% [95%置信区间-0.50至-0.04，p = 0.024]）（-2.88 mmol/mol [95%置信区间-5.37至-0.39]，p = 0.024）。恩格列净使体重从基线至第24周显著降低（-1.72 kg [95%置信区间-1.98至-0.59，p < 0.001]）。恩格列净或度拉糖肽均未报告严重不良事件。
与由DPP4-i转换为每周一次的度拉糖肽相比，恩格列净在接受二甲双胍、磺脲类药物和DPP4-i治疗血糖控制不佳的T2D患者中，能使糖化血红蛋白降低幅度更大且体重减轻。
cris.nih.go.kr（KCT0006157）
