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ADA 2016:诺和诺德降糖药Tresiba(德谷胰岛素U100)治疗1型糖尿病和2型糖尿病低血糖风险显著优于来得时(甘精胰岛素U100)

2016-06-16 佚名 生物谷Bioon.com

糖尿病巨头诺和诺德(Novo Nordisk)近日在美国新奥尔良举行的2016年第76届美国糖尿病协会(ADA)科学会议(2016年06月10日-14日)上公布了长效胰岛素Tresiba(德谷胰岛素U100)2个IIIb期临床研究(SWITCH 1和SWITCH 2)的最新数据。这2个研究是首批完成的双盲基础胰岛素临床研究,比较了Tresiba与赛诺菲重磅胰岛素产品来得时(Lantus,甘精胰


糖尿病巨头诺和诺德(Novo Nordisk)近日在美国新奥尔良举行的2016年第76届美国糖尿病协会(ADA)科学会议(2016年06月10日-14日)上公布了长效胰岛素Tresiba(德谷胰岛素U100)2个IIIb期临床研究(SWITCH 1和SWITCH 2)的最新数据。这2个研究是首批完成的双盲基础胰岛素临床研究,比较了Tresiba与赛诺菲重磅胰岛素产品来得时(Lantus,甘精胰岛素U100)的疗效和安全性。

SWITCH 1研究是SWITCH临床项目中第2个2x32周随机、双盲、交叉、达标治疗研究,在1型糖尿病(T1D)患者中开展,将Tresiba与Lantus进行了疗效和安全性比较。该研究的目的是比较Tresiba和Lantus用于1型糖尿病治疗的低血糖发生率。数据显示,在维持治疗期,Tresiba治疗1型糖尿病(T1D)时低血糖风险显著低于Lantus。与Lantus治疗组相比,Tresiba治疗组在血液葡萄糖(blood glucose,BG)证实的总体有症状低血糖事件发生率降低11%(95%CI:0.85,0.94)、血液葡萄糖(BG)证实的夜间有症状低血糖事件发生率降低36%(95%CI:0.56,0.73)、严重低血糖事件发生率降低35%(95%CI:0.48,0.89)。所有上述分析在整个治疗期间表现出相似的结果。

SWITCH 2研究是SWITCH临床项目中的首个2x32周随机、双盲、交叉、达标治疗研究,在2型糖尿病(T2D)患者中开展,将Tresiba与Lantus进行了疗效和安全性比较。该研究的目的是比较Tresiba和Lantus用于2型糖尿病治疗的低血糖发生率。数据证实,Tresiba治疗2型糖尿病(T2D)时低血糖风险显著低于Lantus。与Lantus治疗组相比,Tresiba治疗组在血液葡萄糖(BG)证实的总体有症状低血糖事件发生率降低30%(95%CI:0.61,0.80)、血液葡萄糖(BG)证实的夜间有症状低血糖事件发生率降低42%(95%CI:0.46,0.74)。上述分析在整个治疗期间表现出显著结果。在维持治疗期,较低的严重低血糖发生率趋势有利于Tresiba治疗组。在整个治疗期间,与Lantus治疗组相比,Tresiba治疗组严重低血糖事件发生率显著减低51%(95%CI:0.26,0.94)。

SWITCH 1和SWITCH 2研究中,Tresiba在治疗期间降低糖化血红蛋白(HbA1c)方面疗效非劣效于Lantus。SWITCH研究中,在治疗期1:Tresiba 6.92% vs Lantus 6.78%;治疗期2:Tresiba 6.95% vs Lantus 6.97%。SWITCH 2研究中,在治疗期1:Tresiba 7.06% vs Lantus 6.98%;治疗期2:Tresiba 7.08% vs Lantus 7.11%。2个研究中,研究结束时胰岛素剂量与每个治疗期结束时胰岛素剂量相似。最常见的不良事件(≥5%)包括鼻咽炎、上呼吸道感染、低血糖。

SWITCH项目:Tresiba治疗糖尿病(T1D & T2D)低血糖风险显著低于Lantus

SWITCH临床项目包括2个研究,SWITCH 1和SWITCH 2,这2个研究均为2x32周随机、双盲、交叉、达标治疗研究,于2014年启动,其目的是比较Tresiba相对于Lantus的疗效和安全性。该项目的总体目标是记录Tresiba治疗1型糖尿病(T1D)和2型糖尿病(T2D)时相对于Lantus的低血糖发生率。

SWITCH 1研究中,501例1型糖尿病(T1D)患者随机分配至Tresiba及Lantus(U100)分别联合门冬胰岛素的交叉治疗。SWITCH 2研究中,2721例2型糖尿病(T2D)患者随机分配至Tresiba及Lantus(U100)分别联合口服降糖药的交叉治疗。

原始出处:

Tresiba (insulin degludec injection U-100) demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs insulin glargine U-100

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GetPortalCommentsPageByObjectIdResponse(id=91298, encodeId=bda29129823, content=期待上市。, beContent=null, objectType=article, channel=null, level=null, likeNumber=132, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160625/IMG576E95DED38602373.jpg, createdBy=a3fa1473764, createdName=hainewhy, createdTime=Mon Jun 27 08:47:00 CST 2016, time=2016-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=90454, encodeId=7b2a9045470, content=好文章,值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=53751677671, createdName=沉心多思, createdTime=Sat Jun 18 18:23:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264589, encodeId=a6781264589ed, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270836, encodeId=652812e08369c, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393162, encodeId=56581393162ad, content=<a href='/topic/show?id=eb2b6882506' target=_blank style='color:#2F92EE;'>#甘精胰岛素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68825, encryptionId=eb2b6882506, topicName=甘精胰岛素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIUEDhSibBFt8TicgFCCSBtW10SxVJicDpibTCucns8L1YaiaKpibWOkv8hYpJ0LeTVUH1Ab4sfica9bxiccA/132, createdBy=dd282500126, createdName=ms3830150583600765, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=)]
    2016-10-04 baoya
  4. 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href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270836, encodeId=652812e08369c, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393162, encodeId=56581393162ad, content=<a href='/topic/show?id=eb2b6882506' target=_blank style='color:#2F92EE;'>#甘精胰岛素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68825, encryptionId=eb2b6882506, topicName=甘精胰岛素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIUEDhSibBFt8TicgFCCSBtW10SxVJicDpibTCucns8L1YaiaKpibWOkv8hYpJ0LeTVUH1Ab4sfica9bxiccA/132, createdBy=dd282500126, createdName=ms3830150583600765, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=)]
    2016-09-21 1e10c84am36(暂无匿称)

    文章很好,非常有益

    0

  5. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393162, encodeId=56581393162ad, content=<a href='/topic/show?id=eb2b6882506' target=_blank style='color:#2F92EE;'>#甘精胰岛素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68825, encryptionId=eb2b6882506, topicName=甘精胰岛素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIUEDhSibBFt8TicgFCCSBtW10SxVJicDpibTCucns8L1YaiaKpibWOkv8hYpJ0LeTVUH1Ab4sfica9bxiccA/132, createdBy=dd282500126, createdName=ms3830150583600765, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=)]
    2016-09-15 舒心和人

    新药不断开发,为健康保驾护航

    0

  6. 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href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270836, encodeId=652812e08369c, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393162, encodeId=56581393162ad, content=<a href='/topic/show?id=eb2b6882506' target=_blank style='color:#2F92EE;'>#甘精胰岛素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68825, encryptionId=eb2b6882506, topicName=甘精胰岛素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIUEDhSibBFt8TicgFCCSBtW10SxVJicDpibTCucns8L1YaiaKpibWOkv8hYpJ0LeTVUH1Ab4sfica9bxiccA/132, createdBy=dd282500126, createdName=ms3830150583600765, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=)]
    2016-06-27 hainewhy

    期待上市。

    0

  7. 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href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270836, encodeId=652812e08369c, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393162, encodeId=56581393162ad, content=<a href='/topic/show?id=eb2b6882506' target=_blank style='color:#2F92EE;'>#甘精胰岛素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68825, encryptionId=eb2b6882506, topicName=甘精胰岛素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIUEDhSibBFt8TicgFCCSBtW10SxVJicDpibTCucns8L1YaiaKpibWOkv8hYpJ0LeTVUH1Ab4sfica9bxiccA/132, createdBy=dd282500126, createdName=ms3830150583600765, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=)]
    2016-06-18 沉心多思

    好文章,值得学习

    0

  8. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393162, encodeId=56581393162ad, content=<a href='/topic/show?id=eb2b6882506' target=_blank style='color:#2F92EE;'>#甘精胰岛素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68825, encryptionId=eb2b6882506, topicName=甘精胰岛素)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIUEDhSibBFt8TicgFCCSBtW10SxVJicDpibTCucns8L1YaiaKpibWOkv8hYpJ0LeTVUH1Ab4sfica9bxiccA/132, createdBy=dd282500126, createdName=ms3830150583600765, createdTime=Sat Jun 18 09:42:00 CST 2016, time=2016-06-18, status=1, ipAttribution=)]
    2016-06-18 般若傻瓜
  9. 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  10. 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