Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus
Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus
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DOI：
10.1016/j.jdiacomp.2012.11.005
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发表时间：
2013-05-01
影响因子：
3
通讯作者：
Klasen, Sally
中科院分区：
文献类型：
--
作者：
Fonseca, Vivian A.;Ferrannini, Ele;Klasen, Sally
目的：评价多剂量伊格列净的疗效、安全性和耐受性。这种新型的钠葡萄糖协同转运蛋白2的选择性抑制剂正在临床开发中，用于治疗2型糖尿病（T2 DM）患者。在一项为期12周、多中心、双盲、随机、活性药物和安慰剂对照的剂量探索研究中，患者被随机分配至4个伊格列净治疗组之一（12.5、50、150和300 mg，每日一次）、安慰剂或活性对照（二甲双胍）。结果：与安慰剂组相比，Ipraglilavine组第12周时HbA 1c呈剂量依赖性降低，降低幅度为-0.49%~-0.81%（P= 50 mg/d，与二甲双胍组疗效相当）。未发现安全性或耐受性问题。(C)2013 Elsevier Inc. All rights reserved.
Aim: To evaluate the efficacy, safety, and tolerability of multiple doses of ipragliflozin. This novel selective inhibitor of sodium glucose co-transporter 2 is in clinical development for the treatment of patients with type 2 diabetes mellitus (T2DM).Methods: In a 12-week, multicenter, double-blind, randomized, active- and placebo-controlled dose-finding study, patients were randomized to one of four ipragliflozin treatment groups (12.5, 50, 150, and 300 mg once daily), placebo, or active control (metformin). The primary efficacy outcome was the mean change from baseline to Week 12 of glycosylated hemoglobin (HbA1c) compared with placebo.Results: Ipragliflozin showed a dose-dependent decrease in HbA1c of -0.49% to -0.81% at Week 12 compared with placebo (P= 50 mg/day in patients with T2DM; an effect comparable to metformin. No safety or tolerability concerns were identified. (C) 2013 Elsevier Inc. All rights reserved.