Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
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DOI：
10.2337/dc12-2673
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发表时间：
2013-11
期刊：
影响因子：
16.2
通讯作者：
EMPA-REG METSU Trial Investigators
中科院分区：
文献类型：
--
作者：
Häring HU;Merker L;Seewaldt-Becker E;Weimer M;Meinicke T;Woerle HJ;Broedl UC;EMPA-REG METSU Trial Investigators
旨在研究恩格列净联合二甲双胍和磺酰脲类药物治疗 2 型糖尿病患者的疗效和耐受性。二甲双胍和磺脲类药物控制不佳的患者（HbA1c ≥7 至 ≤10%）被随机分组，接受每日一次恩格列净 10 mg (n = 225)、恩格列净 25 mg (n = 216) 或安慰剂 (n = 225) 治疗，为期 24 周。主要终点是第 24 周时 HbA1c 相对于基线的变化。关键次要终点是第 24 周时体重和平均每日血糖 (MDG) 相对于基线的变化。在第 24 周时，安慰剂的 HbA1c 相对于基线的调整平均 (SE) 变化为 -0.17% (0.05)，而恩格列净 10 为 -0.82% (0.05) 和 -0.77% (0.05)。分别为 25 毫克和 25 毫克（P < 0.001）。与安慰剂相比，恩格列净显着降低 MDG、体重和收缩压（但不是舒张压）。服用安慰剂和恩格列净 10 mg 和 25 mg 的患者中分别有 62.7%、67.9% 和 64.1% 的患者出现不良事件。服用安慰剂和恩格列净 10 毫克和 25 毫克的患者中，分别有 8.0%、10.3% 和 8.3% 的患者报告了与尿路感染一致的事件（女性：分别为 13.3%、18.0% 和 17.5%；男性：分别为 2.7%、2.7% 和 0%）。服用安慰剂和恩格列净 10 毫克和 25 毫克的患者中，分别有 0.9%、2.7% 和 2.3% 的患者报告了与生殖器感染一致的事件（女性：分别为 0.9%、4.5% 和 3.9%；男性：每组为 0.9%）。恩格列净 10 毫克和 25 毫克，作为二甲双胍加磺酰脲类药物的补充，持续 24 周，改善了血糖控制、体重和收缩压，并且耐受性良好。
To investigate the efficacy and tolerability of empagliflozin as add-on to metformin and sulfonylurea in patients with type 2 diabetes. Patients inadequately controlled on metformin and sulfonylurea (HbA1c ≥7 to ≤10%) were randomized and treated with once-daily empagliflozin 10 mg (n = 225), empagliflozin 25 mg (n = 216), or placebo (n = 225) for 24 weeks. The primary end point was change from baseline in HbA1c at week 24. Key secondary end points were changes from baseline in weight and mean daily glucose (MDG) at week 24. At week 24, adjusted mean (SE) changes from baseline in HbA1c were −0.17% (0.05) for placebo vs. −0.82% (0.05) and −0.77% (0.05) for empagliflozin 10 and 25 mg, respectively (both P < 0.001). Empagliflozin significantly reduced MDG, weight, and systolic (but not diastolic) blood pressure versus placebo. Adverse events were reported in 62.7, 67.9, and 64.1% of patients on placebo and empagliflozin 10 and 25 mg, respectively. Events consistent with urinary tract infection were reported in 8.0, 10.3, and 8.3% of patients on placebo and empagliflozin 10 and 25 mg, respectively (females: 13.3, 18.0, and 17.5%, respectively; males: 2.7, 2.7, and 0%, respectively). Events consistent with genital infection were reported in 0.9, 2.7, and 2.3% of patients on placebo and empagliflozin 10 and 25 mg, respectively (females: 0.9, 4.5, and 3.9%, respectively; males: 0.9% in each group). Empagliflozin 10 and 25 mg for 24 weeks as add-on to metformin plus sulfonylurea improved glycemic control, weight, and systolic blood pressure and were well tolerated.