每周注射1次!诺和诺德长效胰岛素在中国申报临床

2020-09-21 医药魔方 医药魔方

9月21日,诺和诺德在中国提交的icodec胰岛素注射液临床申请获得CDE受理,这是一款每周注射一次的基础胰岛素类似物。

9月21日,诺和诺德在中国提交的icodec胰岛素注射液临床申请获得CDE受理,这是一款每周注射一次的基础胰岛素类似物。

一项II期临床试验结果显示,icodec胰岛素用于成年2型糖尿病患者在血糖控制和安全特性方面与每日注射一次的甘精胰岛素U100类似。该研究为期26周,共纳入247例此前未使用过胰岛素、使用二甲双胍联用或不联用DPP-4i 控制不佳的成年2型糖尿病患者,旨在比较每周注射一次的icodec胰岛素和每日注射一次的甘精胰岛素U100的疗效和安全性差异。主要终点是HbA1c自基线至26周的变化。次要终点包括空腹血糖自基线至26周的变化以及低血糖事件次数。

结果显示,自基线至26周,接受每周注射一次的icodec胰岛素治疗的参加者血糖控制(HbA1c)变化与接受每日注射一次的甘精胰岛素U100治疗的参加者类似(分别为-1.33% vs -1.15%,p=0.08),到达主要终点。次要终点包括空腹血糖自基线至26周的变化,在icodec胰岛素组和甘精胰岛素U100组中,这一变化类似(分别为-58mg/dL和-54mg/dL);而在自基线到26周的9点自测血糖的均值(SMBG)变化方面,icodec胰岛素降幅更大(-7.9 mg/dL; p= 0.01)。

安全性方面,2个治疗组的低血糖发生率类似,未发现与icodec胰岛素相关的新安全性问题。

icodec胰岛素是一种在研的长效基础胰岛素类似物,其半衰期为196小时。在注射进人体后,icodec胰岛素会与白蛋白紧密但可逆的结合在一起。这一结果可在一周时间内连续、缓慢且稳定地降低血糖。基于其浓缩配方,每周注射一次的icodec胰岛素用量与每日注射一次的甘精胰岛素U100相当。

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    2021-10-29 宸歌掩舜弦

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    2020-12-17 baoya
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    2020-09-21 12543f43m99暂无昵称

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