长效GLP-1降糖药semaglutide显著降低2型糖尿病患者重大心血管事件风险(SUSTAIN 6研究)

2016-04-29 MedSci MedSci原创

糖尿病巨头诺和诺德(Novo Nordisk)近日宣布,该公司正在开发的一款新的长效胰高血糖素样肽-1(GLP-1)受体激动剂semaglutide(索马鲁肽)在III期SUSTAIN临床项目第6个也是最后一个III期临床研究(SUSTAIN 6)获得成功。该研究中,约有3300名2型糖尿病(T2D)患者接受semaglutide治疗104周,主要目的是调查2种剂量semaglutide(0.5m

糖尿病巨头诺和诺德(Novo Nordisk)近日宣布,该公司正在开发的一款新的长效胰高血糖素样肽-1(GLP-1)受体激动剂semaglutide(索马鲁肽)在III期SUSTAIN临床项目第6个也是最后一个III期临床研究(SUSTAIN 6)获得成功。该研究中,约有3300名2型糖尿病(T2D)患者接受semaglutide治疗104周,主要目的是调查2种剂量semaglutide(0.5mg,1.0mg,每周一次皮下注射)相对于安慰剂的长期心血管及其他安全性结果。研究的主要终点定义为首次发生心血管死亡、非致死性心肌梗死或非致死性脑卒中的复合结果(研究注册号:NCT01720446)。

数据显示,与安慰剂相比,semaglutide使2型糖尿病患者重大心血管事件(MACE)风险实现统计学意义的显著降低。研究中,大约发生了250例重大心血管事件(MACE),semaglutide的安全性与以往其他临床研究一致。诺和诺德已计划在2016年第4季度向美国和欧盟的监管机构提交semaglutide的上市申请。

糖尿病会增加患者患心脏病、中风等疾病的风险,而心血管并发症发过来也会显著影响糖尿病患者的身体健康及预期寿命。据估计,在全球范围内,大约有50%的2型糖尿病死亡病例是由心血管疾病引起。因此,糖尿病治疗药物一直都被寄予希望能降低患者出现心血管并发症的风险。

业界认为,semaglutide III期SUSTAIN项目的成功,将帮助诺和诺德保持其在快速增长的全球糖尿病市场中的主导地位。ALM Brand银行分析师预测,semaglutide将在2030年达到46-53亿美元的销售峰值。

而在此之前,礼来的降糖药Jardiance是唯一一款在心血管终点试验中被证实可降低心血管风险的降糖药。今年1月底,FDA正式受理Jardiance的补充新药申请,如果获批,Jardiance将成为市面上首个能够减少2型糖尿病患者心血管疾病风险的降血糖药物。

semaglutide是一种新的长效胰高血糖素样肽-1(GLP-1)类似物,每周皮下注射一次,可使2型糖尿病患者血糖水平大幅改善,并且低血糖风险较低。同时,semaglutide还能够通过降低食欲和减少食物摄入量,诱导减肥。除了开发作为一种皮下注射药物,诺和诺德也正在开发semaglutide的口服版本OG217SC,这是每日口服一次的片剂,其中含有促进吸收的赋形剂SNAC。

关于SUSTAIN临床试验计划

The SUSTAIN programme is a phase 3 clinical programme comprising six global trials of semaglutide administered subcutaneously once weekly encompassing more than 7,000 people with type 2 diabetes.

SUSTAIN 1 - a 30-week efficacy and safety trial of semaglutide versus placebo in 388 drug-naïve people with type 2 diabetes. The results were reported in July 2015. 

SUSTAIN 2 - a 56-week efficacy and safety trial of semaglutide versus sitagliptin once-daily as add-on to metformin and/or TZD in 1,231 people with type 2 diabetes. The results were reported in December 2015. 

SUSTAIN 3 - a 56-week efficacy and safety trial of semaglutide versus 2.0 mg exenatide once-weekly as add-on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes. The results were reported in September 2015.

SUSTAIN 4 - a 30-week efficacy and safety trial of semaglutide versus insulin glargine once-daily as add-on to metformin with or without sulfonylurea in 1,089 insulin-naïve people with type 2 diabetes. The results were reported in November 2015. 

SUSTAIN 5 - a 30-week efficacy and safety trial of semaglutide versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in 397 people with type 2 diabetes. The results were reported in February 2016. 

SUSTAIN 6 - a 2-year trial to evaluate cardiovascular and other long-term outcomes with semaglutide in approximately 3,300 people with type 2 diabetes.


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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-09-21 ylzr123

    文章有深度,赞一个。深入学习探讨。

    0

  4. 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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
  5. 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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-05-25 医者仁心5538

    goodnews!waitingforit.

    0

  6. 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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-05-17 stead

    看来这个软件是故意这样子的

    0

  7. 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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-05-17 stead

    评论的人不多,这么多天才这点人看这些

    0

  8. 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topicList=[TopicDto(id=89509, encryptionId=6236895092b, topicName=血管事件)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f99523187183, createdName=hukaixun, createdTime=Sun Aug 28 15:54:00 CST 2016, time=2016-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=87188, encodeId=4a588e188cf, content=goodnews!waitingforit., beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Wed May 25 19:57:00 CST 2016, time=2016-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86162, encodeId=ed5286162d5, content=看来这个软件是故意这样子的, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160509/IMG572FCF18A71237916.jpg, createdBy=d0861720708, createdName=stead, createdTime=Mon May 09 13:50:00 CST 2016, time=2016-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85020, encodeId=455185020da, content=很不错额, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160509/IMG572FCF18A71237916.jpg, createdBy=d0861720708, createdName=stead, createdTime=Mon May 09 13:50:00 CST 2016, time=2016-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=83546, encodeId=a9ef83546d6, content=这个想一下也知道, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-05-09 stead

    学习了,很好的

    0

  9. 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topicList=[TopicDto(id=89509, encryptionId=6236895092b, topicName=血管事件)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f99523187183, createdName=hukaixun, createdTime=Sun Aug 28 15:54:00 CST 2016, time=2016-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=87188, encodeId=4a588e188cf, content=goodnews!waitingforit., beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Wed May 25 19:57:00 CST 2016, time=2016-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86162, encodeId=ed5286162d5, content=看来这个软件是故意这样子的, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160509/IMG572FCF18A71237916.jpg, createdBy=d0861720708, createdName=stead, createdTime=Tue May 17 18:27:00 CST 2016, time=2016-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86161, encodeId=fdda861612e, content=评论的人不多,这么多天才这点人看这些, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160509/IMG572FCF18A71237916.jpg, createdBy=d0861720708, createdName=stead, createdTime=Tue May 17 18:26:00 CST 2016, time=2016-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85019, encodeId=0b508501945, content=学习了,很好的, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-05-09 stead

    很不错额

    0

  10. 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createdBy=0d231626576, createdName=jjzouyan, createdTime=Mon May 02 21:12:00 CST 2016, time=2016-05-02, status=1, ipAttribution=)]
    2016-05-02 jjzouyan

    这个想一下也知道

    0

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