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FDA批准礼来糖尿病新药度拉糖肽（dulaglutide）上市 每周只需一次

2014-10-02 MedSci MedSci原创

Dulaglutide糖尿病新药FDA
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美国食品药品监督管理局(FDA)批准礼来制药公司研发的每周一次度拉糖肽(dulaglutide)注射剂用来治疗2型糖尿病。这是在美国上市的第4个胰高血糖素样肽-1(GLP-1)受体激动剂，此前已批准诺和诺德的利拉鲁肽、阿斯利康/百石美施贵宝的艾塞那肽以及葛兰素史克的阿必鲁肽(albiglutide)。(相关报道：礼来制药降糖新药Dulaglutide非劣效于利拉鲁肽（Liraglutide） (A

美国食品药品监督管理局(FDA)批准礼来制药公司研发的每周一次度拉糖肽(dulaglutide)注射剂用来治疗2型糖尿病。这是在美国上市的第4个胰高血糖素样肽-1(GLP-1)受体激动剂，此前已批准诺和诺德的利拉鲁肽、阿斯利康/百石美施贵宝的艾塞那肽以及葛兰素史克的阿必鲁肽(albiglutide)。(相关报道：礼来制药降糖新药Dulaglutide非劣效于利拉鲁肽（Liraglutide） (AWARD-6研究）)

据悉，度拉糖肽获批的证据来源于6项相关临床研究，其中一项研究显示，度拉糖肽不劣于每日一次的利拉鲁肽;另一项研究表明，该药优于口服二肽基肽酶4抑制剂西格列汀。

度拉糖肽最常见的不良反应是胃肠道不良反应，禁用于1型糖尿病、糖尿病酮症酸中毒、严重胃肠道疾病等情况，不能用于一线降糖治疗。

同时，该药说明书附带黑框警告，动物试验表明该药可能导致甲状腺癌，因此不能用于有甲状腺髓样癌病史或家族史以及2型多发内分泌肿瘤。

礼来制药近日公布的AWARD-6研究结果证明，每周一次的度拉糖肽（1.8mg）的III期临床试验结果优于每日一次的利拉鲁肽（1.5mg）


AWARD-6主要针对用于2型糖尿病治疗，是一项随机、开放标记、平行分组研究，在已接受二甲双胍治疗的2型糖尿病患者中比较度拉糖肽（每周一次）和利拉鲁肽（每日一次）对于血糖控制的影响。

据研究结果显示，每周一次的度拉糖肽达到主要研究终点，即非劣效于每日一次的利拉鲁肽（1.8mg），评估指标为从基线至26周的糖化血红蛋白的降幅。

“度拉糖肽是唯一在III期临床试验中被证实非劣效于liraglutide最高获批剂量的GLP-1受体激动剂，”礼来制药糖尿病事业部总裁Enrique Conterno表示，AWARD-6的研究结果以及此前的五项研究，使我们对度拉糖肽将成为2型糖尿病患者重要的治疗选择充满信心。一旦获批，度拉糖肽将成为目前唯一可以使用的每周一次的GLP-1受体激动剂。

两治疗组患者的不良事件相似，最常报告的是胃肠道相关的不良事件。这些结果与之前度拉糖肽研究的结果一致。

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    2015-09-14 h.y200607_23674430

    #Dulaglutide#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1763304, encodeId=f0f51e633042f, content=<a href='/topic/show?id=9f4b63262b' target=_blank style='color:#2F92EE;'>#Dulaglutide#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6326, encryptionId=9f4b63262b, topicName=Dulaglutide)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=264037462481, createdName=h.y200607_23674430, createdTime=Mon Sep 14 08:59:00 CST 2015, time=2015-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839319, encodeId=cc0718393193c, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Jun 03 21:59:00 CST 2015, time=2015-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=20556, encodeId=f192205566d, content=控制好糖尿病可能提高肝硬化患者的预后。, beContent=null, objectType=article, channel=null, level=null, likeNumber=229, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20150920/IMG55FDE671A89482379.jpg, createdBy=cef3108336, createdName=x35042875, createdTime=Sat Apr 11 23:09:00 CST 2015, time=2015-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=20557, encodeId=f7a72055ec8, content=控制好糖尿病可能提高肝硬化患者的预后。, beContent=null, objectType=article, channel=null, level=null, likeNumber=147, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20150920/IMG55FDE671A89482379.jpg, createdBy=cef3108336, createdName=x35042875, createdTime=Sat Apr 11 23:09:00 CST 2015, time=2015-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1322655, encodeId=4176132265589, content=<a href='/topic/show?id=d5764939166' target=_blank style='color:#2F92EE;'>#度拉糖肽#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=49391, encryptionId=d5764939166, topicName=度拉糖肽)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4736501, createdName=xiaoyang_ambs, createdTime=Sat Oct 04 03:59:00 CST 2014, time=2014-10-04, status=1, ipAttribution=)]
    2015-06-03 bugit

    #FDA批准#

    0

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    2015-04-11 x35042875

    控制好糖尿病可能提高肝硬化患者的预后。

    0

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    2015-04-11 x35042875

    控制好糖尿病可能提高肝硬化患者的预后。

    0

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    2014-10-04 xiaoyang_ambs

    #度拉糖肽#

    0

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