Diabetes Care:度拉糖肽明显改善肥胖和2型糖尿病患者肝脏代谢

2021-06-26 MedSci原创 MedSci原创

度拉糖肽明显改善肥胖和2型糖尿病患者肝脏代谢

GLP-1 RA不是胰岛素,而是一类新型的胰岛素促分泌制剂,其作用机制与天然激素GLP-1类似,促进患者进食时机体自身胰岛素的分泌,具有降糖效果强、低血糖风险较低、同时具有减肥效果和使血管获益的优势。

Trulicitydulaglutide)度易达(度拉糖肽)是一种胰高血糖素样肽-1GLP-1)受体激动剂(RA),每周注射一次,结合饮食控制及锻炼,用于2糖尿病T2DM)成人患者改善血糖控制。20192月,度拉糖肽在中国获得批准,20196月正式上市。

20200903 礼来(Eli Lilly)宣布,美国食品和药物管理局(FDA)已批准度拉糖肽2个额外的剂量(3.0mg4.5mg)用于治疗T2DM。该批准基于3AWARD-11研究的数据。结果显示,在T2DM患者中,与已批准剂量(1.5mg)相比,高剂量(3mg,4.5mg)可进一步改善血糖水平和降低体重。

目前,正在开发用度拉糖肽于非酒精性脂肪性肝炎(NASH)和慢性肾脏病。为此,来自美国阿斯利康生物制药研发部临床代谢的专家在超重/肥胖和T2DM的参与者中,评估了度拉糖肽对肝脏和代谢参数的影响。

在这项2b期研究中,834BMI≥25 kg/m2二甲双胍控制不足的T2DM成人(HbA1c7.0%-10. 5%[53-91 mmol/mol]),随机接受双盲度拉糖肽100 μgn = 100)、200 μgn = 256)或300 μgn = 256);安慰剂(n = 110);或开放标签利拉鲁肽1.8 mgn = 110--均为皮下注射。首要终点是第14周时HbA1c和体重的变化。最初的随机干预措施一直持续到第54周。评估了肝损伤生物标志物和肝纤维化算法。

度拉糖肽(双盲)和利拉鲁肽(开放标签)以每天一次的皮下注射方式进行。

结果显示,与安慰剂相比,度拉糖肽在第14周和第54周明显降低了HbA1c和体重(所有P<0.001)。使用度拉糖肽300μg与安慰剂相比,观察到血脂状况、AST和ALT水平、III型胶原蛋白肽水平、纤维化-4指数和非酒精性脂肪肝纤维化评分的改善,但利拉鲁肽没有。度拉糖肽200ug的体重减轻与利拉鲁肽1.8mg相似,度拉糖肽300ug相对于利拉鲁肽1.8mg更多。使用度拉糖肽最常见的不良事件(恶心,35%;呕吐,17%)随着时间的推移而减少。

不同组间从基线到第54周的血糖和体重结果的变化

度拉糖肽治疗54周,改善了超重/肥胖和2型糖尿病患者的血糖控制和体重减轻。特别分析表明,肝脏参数得到改善,并支持进一步评估度拉糖肽在NASH中的作用。

 

参考文献:

Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study. Diabetes Care 2021 Jun; 44(6): 1433-1442. https://doi.org/10.2337/dc20-2151

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    2022-01-15 ms2000002129129015

    研究里面的cotadutide不是度拉糖肽,你这是拿了cotadutide的数据来说明度拉糖肽有肝脏代谢获益,麻烦分清修正一下标题吧。

    0

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  3. [GetPortalCommentsPageByObjectIdResponse(id=1184539, encodeId=14df118453984, content=研究里面的cotadutide不是度拉糖肽,你这是拿了cotadutide的数据来说明度拉糖肽有肝脏代谢获益,麻烦分清修正一下标题吧。, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06776467583, createdName=ms2000002129129015, createdTime=Sat Jan 15 11:36:02 CST 2022, time=2022-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1902585, encodeId=933519025850e, content=<a href='/topic/show?id=c097591ed5' target=_blank style='color:#2F92EE;'>#Diabetes#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5917, encryptionId=c097591ed5, topicName=Diabetes)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0045169, createdName=木头人513, createdTime=Sat Jan 15 22:13:48 CST 2022, time=2022-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004790, encodeId=ec241004e907f, content=👌, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210326/ff8ca31266094a0b96cc76af821329a9/d16b54784def45618f5a6696eae074c6.jpg, createdBy=e00e5468294, createdName=GY058774, createdTime=Tue Aug 03 00:09:30 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1639794, encodeId=0b2a1639e9432, content=<a href='/topic/show?id=afda591646' target=_blank style='color:#2F92EE;'>#DIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5916, encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Fri May 06 23:13:48 CST 2022, time=2022-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1761627, encodeId=3ae01e6162760, content=<a href='/topic/show?id=9bea33520d' target=_blank style='color:#2F92EE;'>#BET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3352, encryptionId=9bea33520d, topicName=BET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a1a37427546, createdName=ms5439512287675881, createdTime=Thu Jun 09 16:13:48 CST 2022, time=2022-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1322665, encodeId=e1031322665ef, 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=51, 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=Mon Jun 28 04:13:48 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1383700, encodeId=f9ac1383e00c1, content=<a href='/topic/show?id=196a1101f7' target=_blank style='color:#2F92EE;'>#2型糖尿病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1101, encryptionId=196a1101f7, topicName=2型糖尿病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec19483, createdName=aids213, createdTime=Mon Jun 28 04:13:48 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1475091, encodeId=a16a14e5091a8, content=<a href='/topic/show?id=935fe6718e3' target=_blank style='color:#2F92EE;'>#糖尿病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76718, encryptionId=935fe6718e3, topicName=糖尿病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a38f7243741, createdName=xue8604, createdTime=Mon Jun 28 04:13:48 CST 2021, time=2021-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1043668, encodeId=c7e11043668ff, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sat Jun 26 16:13:48 CST 2021, time=2021-06-26, status=1, ipAttribution=)]
    2021-08-03 GY058774

    👌

    0

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    2021-06-26 misszhang

    谢谢MedSci提供最新的资讯

    0

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2月26日,礼来中国宣布,其GLP-1受体激动剂周制剂度易达® (度拉糖肽)获得国家药品监督管理局批准上市,适用于成人2型糖尿病患者的血糖控制,包括单药以及接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的患者。国际糖尿病联盟西太平洋区主席,北京大学人民医院内分泌科主任纪立农教授评价到,“在最近完成的两项以中国2型糖尿病患者为主的临床研究中,度拉糖肽降糖效果优于公认的有强效降糖作用的磺

礼来降糖新药GLP-1受体激动剂周制剂度易达®(度拉糖肽)正式获批进入中国

2019年2月26日,上海—— 礼来中国宣布,其GLP-1受体激动剂周制剂度易达®(度拉糖肽)获得国家药品监督管理局批准上市,适用于成人2型糖尿病患者的血糖控制,包括单药以及接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的患者。

度拉糖肽针对广泛人群2型糖尿病患者心血管事件减少显示优效:REWIND研究中,基线时确诊心血管疾病患者仅有31%

度拉糖肽显著减少主要心血管不良事件(MACE),即包括心血管(CV)死亡、非致死性心肌梗死(心脏病发作)或非致死性卒中的复合终点,达到了REWIND研究预先设立的主要疗效目标。 礼来公司每周给药一次的度拉糖肽,是第一个在大部分为无确诊心血管疾病受试者的临床试验中被证实具有改善MACE事件获益的2型糖尿病治疗药物。 该研究纳入的大多数患者在基线时无确诊心血管疾病,这是第一个GLP-1受体激动剂