EASD 2016:诺和诺德长效GLP-1降糖药semaglutide三大功效:降糖,减肥,降低心血管风险

2016-09-23 佚名 生物谷

糖尿病巨头诺和诺德(Novo Nordisk)近日在德国慕尼黑举行的第52届欧洲糖尿病研究协会(EASD)上公布了该公司正在开发的一款糖尿病新药semaglutide(索马鲁肽)一项III期临床研究(SUSTAIN 5)的新数据。 semaglutide是一种新型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。于此同时,s

糖尿病巨头诺和诺德(Novo Nordisk)近日在德国慕尼黑举行的第52届欧洲糖尿病研究协会(EASD)上公布了该公司正在开发的一款糖尿病新药semaglutide(索马鲁肽)一项III期临床研究(SUSTAIN 5)的新数据。

semaglutide是一种新型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。于此同时,semaglutide还能够通过降低食欲和减少食物摄入量,诱导减肥。此外,semaglutide还能够显著降低2型糖尿病患者重大心血管事件(MACE)风险。

SUSTAIN 5是一项随机、双盲、安慰剂对照、平行组、国际性III期临床研究,在397例糖尿病病程平均持续13.3年的2型糖尿病患者中开展,评估了semaglutide或安慰剂添加至基础胰岛素或基础胰岛素+二甲双胍(metformin)的疗效和安全性。该研究的主要终点是治疗30周后糖化血红蛋白(HbA1c)从基线的变化。次要终点是治疗30周后体重从基线的变化。

研究数据显示,经过30周治疗后,0.5mg和1.0mg剂量semaglutide 2个治疗组糖化血红蛋白(HbA1c)从基线(8.4%)分别下降1.4%和1.8%,安慰剂组仅降低0.1%,数据具有统计学显著差异性和显著优越性,达到了研究的主要终点。此外,0.5mg和1.0mg剂量semaglutide 2个治疗组有显著更多的患者实现HbA1c<7%(61% 和 79% vs 11%)和≤6.5%(41% 和 61% vs 5%)。

次要终点方面,0.5mg和1.0mg剂量semaglutide 2个治疗组体重从基线(91.7公斤)分别下降3.7公斤和6.4公斤,安慰剂组体重下降仅1.4公斤,数据具有显著优于性。此外,与安慰剂组相比,0.5mg和1.0mg剂量semaglutide 2个治疗组空腹血糖(FPG)从基线(8.6mmol/L)也实现了显著更大的降幅(1.6mmol/L和2.4mmol/L vs 0.5mmol/L),同时餐后血糖(PPG)也实现显著更大的降幅。

安全性方面,0.5mg和1.0mg剂量semaglutide治疗组不良事件发生率分别为68.9%和64.1%(安慰剂组为57.9%)、严重不良事件发生率分别为6.1%和9.2%(安慰剂组为6.8%)、因不良事件导致的停药率分别为4.5%和6.1%(安慰剂组为0.8%)。semaglutide治疗组停药事件主要原因是胃肠道不良事件。

semaglutide 3大功效:降糖,减肥,降低重大心血管事件风险

SUSTAIN项目包括6个III期临床研究,涉及超过7000例2型糖尿病患者。今年4月底,该项目中最后一个III期临床研究(SUSTAIN 6)获得成功,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。

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。

SUSTAIN 6研究的成功也标志着该项目的全部6个III期研究圆满完成。业界认为,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。之前,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。

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。

原始出处:

Semaglutide demonstrated superior HbA1c reduction vs placebo as add-on to basal insulin alone or with metformin in adults with type 2 diabetes

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createdName=fengyi812, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422700, encodeId=71301422e0025, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=)]
    2017-07-26 okhuali
  4. 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    2016-10-08 jyzxjiangqin

    降糖,减肥,降低心血管疾病风险。

    0

  5. 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  6. 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createdName=fengyi812, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422700, encodeId=71301422e0025, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=)]
    2016-10-01 doctorJiangchao

    继续关注

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=2082387, encodeId=35a0208238e69, content=<a href='/topic/show?id=56658981223' target=_blank style='color:#2F92EE;'>#血管风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89812, encryptionId=56658981223, topicName=血管风险)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Wed Jun 28 13:06:00 CST 2017, time=2017-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1633170, encodeId=be7e16331e050, content=<a href='/topic/show?id=db1c1612602' target=_blank style='color:#2F92EE;'>#semaglutide#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16126, encryptionId=db1c1612602, topicName=semaglutide)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=214a22029963, createdName=lfyang, createdTime=Sat May 20 05:06:00 CST 2017, time=2017-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1690611, encodeId=acab169061136, content=<a href='/topic/show?id=5c472843a1' target=_blank style='color:#2F92EE;'>#ASD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2843, encryptionId=5c472843a1, topicName=ASD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4e8529069357, createdName=okhuali, createdTime=Wed Jul 26 04:06:00 CST 2017, time=2017-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=142121, encodeId=f21f14212135, content=降糖,减肥,降低心血管疾病风险。, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, 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likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Oct 01 21:25:48 CST 2016, time=2016-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138704, encodeId=4711138e0413, content=继续学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Oct 01 21:25:43 CST 2016, time=2016-10-01, status=1, ipAttribution=), 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createdName=fengyi812, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422700, encodeId=71301422e0025, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=)]
    2016-10-01 doctorJiangchao

    继续学习

    0

  8. 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likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Oct 01 21:25:48 CST 2016, time=2016-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138704, encodeId=4711138e0413, content=继续学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Oct 01 21:25:43 CST 2016, time=2016-10-01, status=1, ipAttribution=), 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createdName=fengyi812, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422700, encodeId=71301422e0025, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=)]
  9. 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likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Oct 01 21:25:48 CST 2016, time=2016-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138704, encodeId=4711138e0413, content=继续学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Oct 01 21:25:43 CST 2016, time=2016-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270846, encodeId=d15512e084618, 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=72, 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=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317259, encodeId=583e131e25947, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422700, encodeId=71301422e0025, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Sun Sep 25 11:06:00 CST 2016, time=2016-09-25, status=1, ipAttribution=)]
    2016-09-25 fengyi812
  10. 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    2016-09-25 yibei

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