糖尿病新药进展!武田2型糖尿病复方药Inisync(阿格列汀/二甲双胍)获日本批准

2016-10-08 佚名 生物谷

日本制药巨头武田(Takeda)近日宣布,日本卫生劳动福利部(MHLW)已批准糖尿病复方新药Inisync复方片,用于2型糖尿病的治疗。Inisync复方片由固定剂量的Nesina(阿格列汀,alogliptin,25mg)和二甲双胍(500mg)组成,每日口服一次。此次批准,使Inisync成为日本市场唯一一种每日口服一次的DPP-4和二甲双胍复方药。 Inisync的获批,是基于与Nes

日本制药巨头武田(Takeda)近日宣布,日本卫生劳动福利部(MHLW)已批准糖尿病复方新药Inisync复方片,用于2型糖尿病的治疗。Inisync复方片由固定剂量的Nesina(阿格列汀,alogliptin,25mg)和二甲双胍(500mg)组成,每日口服一次。此次批准,使Inisync成为日本市场唯一一种每日口服一次的DPP-4和二甲双胍复方药。

Inisync的获批,是基于与Nesina相关的现有临床数据以及在日本开展的Inisync的III期临床研究。所有这些临床试验均调查了Nesina和二甲双胍联合用药的疗效和安全性。来自III期临床的数据显示,与Nesina单药治疗和二甲双胍单药治疗相比,Nesina+二甲双胍同时用药(每日一次)使糖化血红蛋白(HbA1c)实现了显著更大幅度的降低,达到了研究的主要终点。研究中,Nesina和二甲双胍同时用药的安全性与2种药物单独用药的安全性一致。

Nesina是一种口服二肽基肽酶-4抑制剂(DPP-4i),可减缓肠促胰岛素激素(incretin hormones)胰高血糖素样肽-1(GLP-1)和葡萄糖依赖性促胰岛素多肽(GIP)的失活,从而增加活性肠促胰岛素的总量,使胰脏以一种葡萄糖依赖的方式分泌胰岛素,协助管理血糖水平。

二甲双胍则是一种双胍类药物,常用作2型糖尿病早期治疗的一线药物,可单独或与其他药物(包括胰岛素)联合用药。在2型糖尿病患者中,肝脏产生过量的葡萄糖(glucose),从而推高血糖水平。二甲双胍可通过降低肝脏产生葡萄糖的量、增加肌肉对葡萄糖的敏感性、延缓肠道的葡萄糖吸收,降低机体的血糖水平。

目前,这2种药物均已被广泛用于2型糖尿病的治疗。而将DPP-4抑制剂与二甲双胍联合用药,具有机制互补和协同增效作用,将为广大2型糖尿病群体提供一种更有效的治疗选择。

原始出处:

Takeda Obtains New Drug Application Approval for Inisync® Combination Tablets for the Treatment of Type 2 Diabetes in Japan


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    2016-10-11 知难而进

    继续关注!

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    2016-10-11 知难而进

    谢谢分享!

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