Abstract：
OBJECTIVE: To compare the effectiveness and safety of empagliflozin and dulaglutide in patients with type 2 diabetes (T2D) inadequately controlled by oral triple therapy.
METHODS: In this 24-week, multi-center, randomized trial, patients with T2D and HbA1c 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 HbA1c at 24 weeks.
RESULTS: 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.
CONCLUSIONS: Empagliflozin, compared with once-weekly dulaglutide switched from DPP4-i, demonstrated greater HbA1c reduction and weight loss in patients with T2D inadequately controlled with metformin, sulfonylurea, and DPP4-i.
BACKGROUND: cris.nih.go.kr (KCT0006157).
METHODS: In this 24-week, multi-center, randomized trial, patients with T2D and HbA1c 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 HbA1c at 24 weeks.
RESULTS: 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.
CONCLUSIONS: Empagliflozin, compared with once-weekly dulaglutide switched from DPP4-i, demonstrated greater HbA1c reduction and weight loss in patients with T2D inadequately controlled with metformin, sulfonylurea, and DPP4-i.
BACKGROUND: cris.nih.go.kr (KCT0006157).
摘要：
目的：比较依帕列净和杜拉鲁肽在口服三联疗法控制不佳的2型糖尿病（T2D）患者中的有效性和安全性。
方法：在这24周，多中心,随机试验,T2D和HbA1c水平≥7.5％（58mmol/mol）的患者服用二甲双胍，磺酰脲,和二肽基肽酶4抑制剂（DPP4-i）被随机分为两组：每天添加依帕列净或从DPP4-i转换为每周一次的杜拉鲁肽。主要终点是24周时基线HbA1c的变化。
结果：总计，152名患者被招募到添加了empagliflozin的四联组（n=76）或转换为杜拉鲁肽三联组（n=76）。在第24周，两组均显示HbA1c水平从基线显着降低，而依帕列净的降低更大（平均治疗差异：-0.27％[95％CI-0.50至-0.04，p=0.024]）（-2.88mmol/mol[95％CI-5.37至-0.39]，p=0.024)。Empagliflozin从基线到第24周显着降低了体重（-1.72kg[95％CI-1.98至-0.59，p<0.001]）。未报告使用依帕列净或杜拉鲁肽的严重不良事件。
结论：Empagliflozin，与DPP4-i每周一次的杜拉鲁肽相比，在二甲双胍控制不足的T2D患者中，HbA1c降低和体重减轻更大，磺酰脲,和DPP4-i。
背景：cris。nih.走吧。kr(KCT0006157)。
方法：在这24周，多中心,随机试验,T2D和HbA1c水平≥7.5％（58mmol/mol）的患者服用二甲双胍，磺酰脲,和二肽基肽酶4抑制剂（DPP4-i）被随机分为两组：每天添加依帕列净或从DPP4-i转换为每周一次的杜拉鲁肽。主要终点是24周时基线HbA1c的变化。
结果：总计，152名患者被招募到添加了empagliflozin的四联组（n=76）或转换为杜拉鲁肽三联组（n=76）。在第24周，两组均显示HbA1c水平从基线显着降低，而依帕列净的降低更大（平均治疗差异：-0.27％[95％CI-0.50至-0.04，p=0.024]）（-2.88mmol/mol[95％CI-5.37至-0.39]，p=0.024)。Empagliflozin从基线到第24周显着降低了体重（-1.72kg[95％CI-1.98至-0.59，p<0.001]）。未报告使用依帕列净或杜拉鲁肽的严重不良事件。
结论：Empagliflozin，与DPP4-i每周一次的杜拉鲁肽相比，在二甲双胍控制不足的T2D患者中，HbA1c降低和体重减轻更大，磺酰脲,和DPP4-i。
背景：cris。nih.走吧。kr(KCT0006157)。
