Department of Medicine, Kawasaki Medical School, Okayama, Japan.
Japan/Asia Clinical Development, Astellas Pharma Inc., Tokyo, Japan.
J Diabetes Investig. 2020 May;11(3):662-671. doi: 10.1111/jdi.13181. Epub 2020 Feb 20.
The aim of the present study was to assess the long-term (52-week) efficacy and safety of ipragliflozin in insulin-treated Japanese patients with type 1 diabetes mellitus and inadequate glycemic control.
In this 28-week, open-label extension of a multicenter, randomized, placebo-controlled, 24-week phase III study, ipragliflozin recipients continued treatment (50 mg, once daily), and placebo recipients were switched to once-daily 50 mg ipragliflozin at the start of the extension period. The ipragliflozin dose could be increased to 100 mg if warranted. The primary end-point was change in glycated hemoglobin; secondary end-points were change in insulin dose and bodyweight. Safety outcomes were monitored as treatment-emergent adverse events.
A total of 53 (placebo switched to ipragliflozin) and 108 (ipragliflozin) patients completed the open-label extension (treatment period 2), with 24 and 44 patients, respectively, receiving dose increases. From baseline to end of treatment, the overall mean change (standard deviation [SD]) in glycated hemoglobin was -0.33% (0.72; -3.7 mmol/mol [7.9]), with changes in basal, bolus and total insulin doses of -3.76 IU (SD 3.85 IU), -2.51 IU (SD 7.08 IU) and -6.27 IU (SD 8.16 IU), respectively. No serious drug-related treatment-emergent adverse events or deaths were reported. Treatment-emergent adverse events leading to study discontinuation occurred in zero and three (2.6%) patients in the placebo switched to ipragliflozin and ipragliflozin groups, respectively; all were considered drug-related. There were no cases of severe hypoglycemia or diabetic ketoacidosis, and no safety concerns related to dose increase.
The efficacy and safety of 50 mg, once-daily ipragliflozin in insulin-treated type 1 diabetes mellitus patients were confirmed in this long-term, open-label extension study. No safety concerns were attributed to a dose increase to 100 mg.
本研究旨在评估伊格列净在血糖控制不佳的胰岛素治疗的日本 1 型糖尿病患者中的长期（52 周）疗效和安全性。
在这项为期 28 周的多中心、随机、安慰剂对照、24 周 III 期研究的开放标签扩展研究中，伊格列净组继续接受治疗（50mg，每日一次），安慰剂组在扩展期开始时转换为每日一次 50mg 伊格列净。如果需要，伊格列净剂量可增加至 100mg。主要终点为糖化血红蛋白的变化；次要终点为胰岛素剂量和体重的变化。安全性结果作为治疗中出现的不良事件进行监测。
共有 53 名（安慰剂转换为伊格列净）和 108 名（伊格列净）患者完成了开放标签扩展（治疗期 2），分别有 24 名和 44 名患者增加了剂量。从基线到治疗结束，糖化血红蛋白的总体平均变化（标准差[SD]）为-0.33%（0.72；-3.7mmol/mol[7.9]），基础、大剂量和总胰岛素剂量分别变化-3.76IU（SD 3.85IU）、-2.51IU（SD 7.08IU）和-6.27IU（SD 8.16IU）。未报告严重与药物相关的治疗中出现的不良事件或死亡。安慰剂转换为伊格列净组和伊格列净组分别有 0 名（0%）和 3 名（2.6%）患者因治疗中出现的不良事件而退出研究，均认为与药物相关。无严重低血糖或糖尿病酮症酸中毒病例，且剂量增加无安全性问题。
在这项长期、开放标签扩展研究中，证实了 50mg、每日一次伊格列净在胰岛素治疗的 1 型糖尿病患者中的疗效和安全性。增加至 100mg 剂量未引起安全性问题。
