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).
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)。