A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes
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DOI：
10.1111/dom.12081
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发表时间：
2013-08-01
影响因子：
5.8
通讯作者：
Woerle, H. J.
中科院分区：
文献类型：
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作者：
Ferrannini, E.;Seman, L.;Woerle, H. J.
目的：这项IIb期随机、双盲、安慰剂对照试验评价了依帕利嗪在2型糖尿病患者中的疗效、安全性、耐受性和药代动力学。方法：408名患者(治疗初期或经过4周洗脱期后)随机分为3组，每日1次服用依帕利嗪5、10或25 mg，安慰剂或开放标签的二甲双胍，疗程12周。结果：治疗12周后，依帕格列酮治疗后HbA1c呈剂量依赖性下降[5 mg：-0.4%，10 mg：-0.5%，25 mg：-0.6%；P
Aim: This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.Methods: Four hundred and eight patients (treatment-naive or after a 4-week wash-out period) were randomized to receive empagliflozin 5, 10 or 25mg once daily, placebo or open-label metformin for 12weeks. The primary endpoint was change in haemoglobin A1c (HbA1c ) after 12weeks.Results: After 12weeks' treatment, empagliflozin showed dose-dependent reductions in HbA1c from baseline [5mg: -0.4%, 10mg: -0.5%, 25mg: -0.6%; all doses p