A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).
Study details include:
* The study duration per participant will be approximately up to 24 weeks.
* The treatment duration will be up to 20 weeks.
* The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
* Health measurement/Observation: change in TIR as the primary endpoint
* Intervention name: iGlarLixi and Gla-100
* Participant gender: male and female
* Participant age range: adults at least 18 years of age
* Condition/disease: type 2 diabetes
* Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.

开始日期2024-12-23

申办/合作机构

Sanofi

CTRI/2024/10/075222 / Not yet recruiting临床4期

A Multicentre Phase IV single arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Insulin Glargine and Lixisenatide in adult patients with Type 2 diabetes who are sub optimally controlled on oral anti-hyperglycemic drugs and/or basal Insulin/GLP-1 RA - iGlarLixi Phase 4 study in India

开始日期2024-10-28

申办/合作机构

Sanofi Healthcare India Pvt Ltd.

ChiCTR2400086382 / Suspended临床4期IIT

Safety and efficacy of GLP-1RA combined with Banxia Xiexin Decoction in the treatment of type 2 diabetes

开始日期2024-07-15

申办/合作机构-

100 项与甘精胰岛素利司那肽相关的临床结果

登录后查看更多信息

100 项与甘精胰岛素利司那肽相关的转化医学

登录后查看更多信息

100 项与甘精胰岛素利司那肽相关的专利（医药）

登录后查看更多信息

132

项与甘精胰岛素利司那肽相关的文献（医药）

2024-12-01·Diabetes, Obesity and Metabolism

iGlarLixi effectively reduces residual hyperglycaemia in Chinese people with type 2 diabetes on basal insulin: A post hoc analysis of the LixiLan‐L‐CN study

Article

作者: Zhang, Minlu ; Fang, Hexin ; Lauand, Felipe ; Kang, Lei ; Du, Qin ; Wang, Kun ; Guo, Xiaohui ; Yuan, Xiaoyong ; Alvarez, Agustina ; Li, Dongmei

AbstractAimTo compare the effects of iGlarLixi versus insulin glargine 100 U/mL (iGlar) on residual hyperglycaemia in Chinese people with uncontrolled type 2 diabetes (T2D) on prior basal insulin (BI) therapy ± oral antidiabetic drugs in the LixiLan‐L‐CN study (NCT03798080).Materials and MethodsIn this post hoc analysis, residual hyperglycaemia (i.e. HbA1c ≥ 7.0% [≥ 53 mmol/mol] and fasting plasma glucose [FPG] < 7.0 mmol/L) were assessed over 30 weeks. Outcomes were assessed at week 30 in participants with baseline residual hyperglycaemia, including changes from baseline in HbA1c, FPG, 2‐hour postprandial glucose (PPG) and daily BI dose, the proportion of participants with HbA1c less than 7.0% (< 53 mmol/mol) and FPG less than 7.0 mmol/L and the incidence of hypoglycaemia.ResultsOf 421 participants, 124 (29.5%) had baseline residual hyperglycaemia (iGlarLixi, n = 64 [31.7%]; iGlar, n = 60 [29.1%]). At week 30, the residual hyperglycaemia rate decreased to 7.0% with iGlarLixi and increased to 43.3% with iGlar. Among participants with baseline residual hyperglycaemia, a greater proportion achieved both HbA1c and FPG targets at week 30 with iGlarLixi versus iGlar (43.8% vs. 16.7%), and iGlarLixi provided greater reductions in HbA1c (least squares mean [LSM] difference, −0.9% [−9.4 mmol/mol]) and 2‐hour PPG (LSM difference, −4.7 mmol/L; both P < .001). Daily BI dose and incidence of hypoglycaemia were similar in the two groups.ConclusionsThe findings of this post hoc analysis suggest that iGlarLixi had greater benefits than iGlar in reducing the rate of residual hyperglycaemia over 30 weeks in Chinese people with suboptimally controlled T2D on prior BI‐based therapy.

2024-11-01·Diabetes Therapy

Real-Life Effectiveness of iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) in People with Type 2 Diabetes (T2D) According to Baseline HbA1c and BMI

Article

作者: Guja, Cristian ; Bonnemaire, Mireille ; Tournay, Mathilde ; Kis, Janos T. ; Kis, Janos T ; Vera, Carine ; Seufert, Jochen ; Freemantle, Nick ; Haluzík, Martin

INTRODUCTIONThis study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice.METHODSWe pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m² and 510 (36%) a BMI < 30 kg/m²; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%.RESULTSAfter initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups.CONCLUSIONSInitiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.

2024-11-01·Diabetes, Obesity and Metabolism

Time‐in‐range derived from self‐measured blood glucose in people with type 2 diabetes advancing to iGlarLixi: A participant‐level pooled analysis of three phase 3 LixiLan randomized controlled trials

Article

作者: Cheng, Alice Y. Y. ; Haluzík, Martin ; Lauand, Felipe ; Al‐Sofiani, Mohammed E. ; Melas‐Melt, Lydie ; Rosenstock, Julio

AbstractAimTo evaluate the efficacy of a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D) using derived time‐in‐range (dTIR).MethodsParticipant‐level data from LixiLan‐L, LixiLan‐O and LixiLan‐G were pooled and dTIR (70‐180 mg/dL), derived time‐above‐range (> 180 mg/dL) and derived time‐below‐range (dTBR; < 70 mg/dL) were calculated from participant seven‐point self‐monitored blood glucose profiles.ResultsThis pooled analysis included data from 2420 participants receiving iGlarLixi (n = 1093), iGlar (n = 836), Lixi (n = 234) or a glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) (n = 257). Numerically greater improvements in least square (LS) means dTIR were seen from baseline to end of treatment (EOT) with iGlarLixi (25.7%) versus iGlar (15.8%), Lixi (11.7%) or GLP‐1 RA (16.2%). At EOT, the mean (standard deviation) dTBR was 0.71% ± 3.4%, 0.61% ± 3.2%, 0.08% ± 1.0% and 0.0% ± 0.0% for iGlarLixi, iGlar, Lixi and GLP‐1 RA, respectively. In a subgroup analysis, participants aged younger than 65 years (n = 1690) and 65 years or older (n = 713) showed numerically greater improvements in LS means dTIR from baseline to EOT with iGlarLixi versus iGlar, Lixi or GLP‐1 RA.ConclusionsiGlarLixi achieved improvements in dTIR, with low dTBR values, providing further evidence to inform clinical outcomes with the use of iGlarLixi.

项与甘精胰岛素利司那肽相关的新闻（医药）

2024-11-15

·国际糖尿病idiabetes

2024CDS重磅丨李延兵教授：洞悉趋势、紧跟前沿，FRC开启“精准稳控”新篇章

编者按 2024年11月13—16日，由中华医学会、中华医学会糖尿病学分会主办，江苏省医学会承办的中华医学会糖尿病学分会第二十六次学术会议（2024 CDS）在南京盛大召开。作为全国糖尿病领域的年度盛会，2024 CDS汇集国内外顶尖专家与学者，聚焦领域最前沿、分享研究新成果、共谋诊疗新未来。本期“FRC行知学苑”特邀中山大学附属第一医院李延兵教授，带领大家一起深入探索血糖管理领域的最新趋势，回顾在全球范围内引起广泛关注的重大研究成果，并基于最新分析结果展望有望引领未来发展的创新方案，最终为患者带来更加高效、个性化的治疗与管理策略，共同推动血糖管理领域的持续进步与发展。大咖观点·精彩视频洞悉趋势血糖管理正迈向精准化、个体化时代近年来，随着糖尿病管理理念的持续革新与监测技术的飞速发展，血糖管理领域正经历着前所未有的变革。传统的“一刀切”式治疗策略逐渐被更为细致、深入的精准化管理和个体化管理模式所取代。在精准化血糖管理方面，除了空腹血糖（FPG)、餐后血糖(PPG)和糖化血红蛋白（HbA1c）等传统控糖指标外，越来越强调关注反映血糖波动的相关指标，如葡萄糖在目标范围内时间（TIR）、葡萄糖高于目标范围时间（TAR）、葡萄糖低于目标范围时间（TBR）等的重要性。其中TIR更是广受关注，自2019年发布TIR国际共识[1]到2024年最新版美国糖尿病协会（ADA）指南[2]均推荐，将TIR>70%作为血糖控制的重要目标。此外，鉴于我国大部分T2DM患者伴有PPG高[3]，以及低血糖带来的严重危害，因此这两个指标也格外需要加强重视和管理。2024 ADA指南[2]指出，如果尽管达到了餐前血糖目标但仍未达到HbA1c目标，则可将PPG作为目标；同时，强调在选择糖尿病药物和设定血糖目标时，应考虑个体的低血糖风险。在个体化血糖管理方面，《2022 ADA/EASD共识报告：2型糖尿病的高血糖管理》[4]指出，评估个人关键特征、考虑影响治疗选择的具体因素，是降糖治疗决策的重要环节。2024 ADA指南[2]也强调，血糖的目标和管理应个体化，而非“一刀切”。根据这些指南共识建议，临床上越来越多的医生会结合患者的个体特征，比如年龄、糖化血红蛋白（HbA1c）水平、C肽水平等，来制定个性化降糖方案。总之，血糖管理正步入精准化、个体化管理的全新时代，通过先进的监测技术和定制化的治疗策略，旨在为患者带来最佳的血糖控制效果。紧跟前沿 SoliD研究照亮中国血糖管理之路当前，我国众多2型糖尿病（T2DM）患者在口服降糖药（OADs）治疗下血糖控制仍不理想，面临OADs治疗失效的困境，亟需转向包括胰岛素及GLP-1受体激动剂（GLP-1RA）在内的注射治疗方案。其中预混胰岛素类使用较广，但在血糖控制、低血糖风险及体重管理等方面仍有待进一步改善。在此背景下，由母义明教授牵头开展了针对中国患者的SoliD研究（磐石研究），其主研究结果在今年ADA和欧洲糖尿病研究协会（EASD）年会上相继揭晓，引起了业界的高度关注与强烈反响。 SoliD研究[5]是一项为期24周的随机对照、开放标签、多中心的头对头比较研究，旨在接受一种或两种OADs治疗血糖控制不佳的T2DM患者中，比较固定比例复方制剂（FRC）甘精利司（iGlarLixi）与德谷门冬（IDegAsp）的疗效和安全性。而该研究之所以备受瞩目，主要在于其具有以下几个亮点：全球首个：该研究是全球首个针对OADs控制不佳T2DM患者，采用FRC甘精利司对比德谷门冬的头对头、随机对照、开放标签的研究。聚焦本土：SoliD研究完全立足中国本土，选取近600名OADs控制不佳的中国T2DM患者，在二甲双胍±SGLT-2抑制剂（SGLT-2i）基础上，随机接受甘精利司或德谷门冬治疗，一天一次注射，共治疗24周。结果惊艳：（1）在OADs控制不佳的中国患者中，甘精利司相比德谷门冬，自基线至24周的HbA1c降幅达到了非劣效与优效标准，两组差值-0.2%，具有统计学意义；（2）在两组FPG降幅相当的情况下，甘精利司三餐后平均血糖较德谷门冬进一步下降25%；（3）此外，甘精利司较德谷门冬总体低血糖事件率减少29%，并较德谷门冬实现-1.49 kg的体重获益。这项基于中国人群的研究数据，为T2DM患者OADs失效后的治疗带来了新的选择，特别是对于PPG高、关注低血糖风险及体重变化的患者群体，它犹如一盏明灯，照亮了中国血糖管理的前行之路。引领未来 FRC开启“精准稳控”新篇章如前所述，在控糖达标的基础上，如何进一步实现精准化血糖管理，并制定个体化方案，是亟需回答的临床问题。本次CDS大会上公布的两项针对SoliD研究的事后分析，对此给出了很好的回答。 01 FRC甘精利司较德谷门冬可显著改善衍生TIR(dTIR) TIR是反映血糖波动性的重要指标，可以用于更好地评估治疗方案的控糖效果。而当持续血糖监测（CGM）数据无法获得时，常使用dTIR代替TIR为临床提供稳控血糖的更多信息。本次发布的其中一项事后分析[6]纳入SoliD研究意向治疗人群且在基线和至少一次基线后访视时具备7点SMBG血糖谱的受试者，分别计算dTIR(3.9-10 mmol/L)、衍生TBR（dTBR）（<3.9 mmol/L）和衍生TAR（dTAR）（>10 mmol/L)的比例，并评估两组平均餐后2小时血糖情况。主要结果第24周时，甘精利司组和德谷门冬组dTIR分别为81.0%和73.4%，较基线的增幅甘精利司组(45.0%)显著大于德谷门冬组(36.7%)，估计治疗差异（ETD）为8.3%（图1A）。甘精利司组达到dTIR≥70%和dTIR较基线增幅≥5%的患者比例均较德谷门冬组更高（图1B）。图1A 基线、12和24周时，甘精利司组和德谷门冬组dTIR 图1B 24周时甘精利司组达到dTIR≥70%和dTIR较基线增幅≥5%的患者比例第24周时，甘精利司组和德谷门冬组dTAR分别为18.4%和26.4%，较基线的降幅甘精利司组(-45.5%)显著大于德谷门冬组(-36.9%)，ETD为-8.6%。该事后分析显示，在OADs控制不佳的中国T2DM患者中，甘精利司较德谷门冬可更好改善dTIR、提高达到TIR共识目标的患者比例，同时降低dTAR。可见，在OADs控制不佳患者中，甘精利司在平稳血糖波动、改善餐后血糖方面均较德谷门冬更具优势，为精准化血糖管理提供了有力支持和更优选择。 02 无论c肽水平如何，甘精利司均有效降低患者的HbA1c水平 C肽水平作为反映胰岛β细胞功能的重要指标，为临床医生制定个体化方案提供了重要指导。本次发布的另一项事后分析是一项针对SoliD研究的亚组分析[7]，旨在根据患者基线空腹C肽水平的四分位数来评估甘精利司与德谷门冬的疗效和安全性。主要结果 HbA1c降幅与C肽四分位数之间无交互作用（Pint=0.056）。 SoliD主研究结果显示，24周时与德谷门冬相比，甘精利司治疗达到HbA1c <7.0%、无体重增加且治疗期间无低血糖的受试者比例显著更高。本次分析显示，24周时空腹C肽四分位亚组与实现HbA1c<7.0%且无体重增加和低血糖的受试者比例之间未观察到显著的相互作用（Pint=0.738）（见图2）。在24周的治疗期中，与德谷门冬相比，甘精利司治疗的整体低血糖事件率显著更低，且所有C肽四分位数亚组间无显著差异（Pint=0.319）。图2. 24周时空腹C肽四分位亚组实现HbA1c<7.0%且无体重增加和低血糖的受试者比例这项事后分析表明，对于OADs控制不佳的中国成人T2DM患者，无论C肽水平如何，甘精利司均是一种有效的治疗方法。参考文献：（上下滑动查看更多） [1]Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8. PMID: 31177185; PMCID: PMC6973648. [2]American Diabetes Association Professional Practice Committee. 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S111-S125. doi: 10.2337/dc24-S006. PMID: 38078586; PMCID: PMC10725808. [3]母义明,纪立农,杨文英,等.中国2型糖尿病患者餐后高血糖管理专家共识[J].中国糖尿病杂志,2016,24(5):385-392.DOI:10.3969/j.issn.1006-6187.2016.05.001. [4]Davies MJ, Aroda VR, Collins BS, et al. Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24. PMID: 36151309; PMCID: PMC9510507. [5]Liu M, Gu W, Chen L, et al. The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli-D randomized controlled trial. Diabetes Obes Metab. 2024 Sep;26(9):3791-3800. doi: 10.1111/dom.15724. Epub 2024 Jun 22. PMID: 38922731. [6]Iglarlixi Provides A Higher Derived Time-In-Range Versus Idegasp In Chinese People With Type 2 Diabetes: A Post Hoc Analysis Of The Solid Study.CDS 2024. [7]Efficacy And Safety Of Iglarlixi Vs Idegasp By Baseline C−Peptide Levels In Chinese People With Type 2 Diabetes: Prespecified Exploratory Analyses Of The Solid Study.CDS 2024. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。 MAT-CN-2419116，V2，审批日期2024年11月最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

2024-11-13

·凯莱英药闻

赛诺菲：联合投资2000万美元，获“首创”靶向SSTR2 1型糖尿病新药优先谈判权

欢迎关注凯莱英药闻 2024年11月12日，Zucara Therapeutics宣布，公司获得赛诺菲和PXV Fund I约2000 万美元的战略融资，作为该公司B轮融资的一部分。作为回报，赛诺菲获得ZT-01的独家优先谈判权。此次融资还将资助ZT-01正在进行的 2a 期试验的剩余部分，旨在评估 ZT-01 对1 型糖尿病（“T1D”）患者夜间低血糖事件的影响。关于ZT-01 ZT-01是一款生长抑素2型 (SSTR2)受体拮抗剂，能够预防使用胰岛素疗法的人发生低血糖。该药物每日一次，在1型糖尿病的治疗中具有潜在“同类首创”的作用机理。 1b 期概念验证试验显示：（1）近 90% 的受试者在服用 ZT-01 后胰高血糖素显著增加。（2）与安慰剂相比，采用3 mg和 20 mg ZT-01 ，分别导致峰值胰高血糖素相对于基线平均变化 14 pg/mL 和 20 pg/mL（p<0.0001）；16名受试者胰高血糖素比安慰剂增加了10 pg/mL以上。（3）研究未观察到严重的不良事件。临床前试验在腹膜内或皮下给药，以评估 ZT-01的药代动力学，显示：（1）腹腔给药后1小时内，ZT-01的血浆Cmax比早期的SSTR2抑制剂候选药物PRL-2903高10倍以上。（2）ZT-01经腹腔和皮下24小时暴露量分别为4.7倍和11.3倍。（3）在给药、PRL-2903或ZT-01后，达到超过3.0 mmol/L的低血糖的中位时间分别为60分钟、70分钟和125分钟。（4）注射ZT-01的大鼠在胰岛素给药后，血糖最低点明显高于PRL-2903。（5）在降糖钳夹期间，ZT-01比PRL-2903使胰高血糖素峰值反应提高了约4倍。关于SSTR2药物胰腺生长抑素 (SST)是一种多功能的多肽激素，由大脑、胃肠道、视网膜、免疫和神经内分泌细胞以及胰岛D细胞对不同的刺激产生。SST作为不同细胞功能的内源性抑制性调节因子，能调节发育、增殖、代谢、分泌和神经等过程，主要通过结合5种生长抑素受体(SSTR1-5)发挥广泛的生物效应。对于没有糖尿病的人来说，α 细胞会分泌胰高血糖素，向身体发出信号，释放自己的葡萄糖储备，以防止或逆转低血糖。然而，对于胰岛素依赖型糖尿病患者（包括患有 1 型糖尿病和胰岛素依赖型 2 型糖尿病的人），有证据表明，SST分泌增多会抑制 α 细胞释放胰高血糖素。目前，基于SSTR2靶点特性有多种药物开发形式：如核药、SSTR2激动剂、SSTR2拮抗剂、多肽偶联药物等，适应症涵盖肿瘤、罕见疾病、内分泌及代谢领域。关于1型糖尿病糖尿病是危害人类健康最常见的慢性疾病之一，我国已经成为全球糖尿病患病人数增长最快的国家，18岁以上人群糖尿病患病率超过10%。近年来，糖尿病发病年轻化也是不容小窥的公共卫生问题。根据2019年世界卫生组织（WHO）最新的糖尿病分型标准，糖尿病分为1型糖尿病、2型糖尿病、妊娠糖尿病、混合型糖尿病、未分类型糖尿病、特殊类型糖尿病。 1型糖尿病的病人是由于免疫系统的破坏导致的，主要是免疫系统对胰岛β细胞的破坏，造成绝大部分的胰岛β细胞受到严重的损害，导致胰岛β细胞死亡。残留的胰岛β细胞比较少，产生的胰岛素，不能满足身体的需要，造成血糖的升高。据推测，全球可能有230万人患有1型糖尿病。根据翁建平教授等人在2010~2013年调查发现，中国所有年龄段的T1DM发病率估计为1.01/10万人年。除了每天注射胰岛素外，T1D患者还需要采取严格的管理计划，包括定期监测血糖、健康饮食和体育锻炼。关于赛诺菲在糖尿病领域的布局赛诺菲在全球糖尿病市场都占据着领先地位，布局了多款小分子降糖药和胰岛素、多肽药物；其中，代表药物甘精胰岛素利司那肽同时含有基础胰岛素与GLP-1 RA双重组分，一天一针就能有效控制患者的空腹血糖和餐后血糖，有效减少了注射次数，控糖简便且全面。在1型糖尿病领域，早在2015年，赛诺菲曾与Lexicon达成17亿美元的授权协议，获得索格列净除日本之外的全球独家权利。然而在2019年7月，赛诺菲宣布与Lexicon终止合作，理由是在治疗伴有中度（3期）和重度（4期）慢性肾脏病（CKD）的2型糖尿病患者中开展的2项III期研究（SOTA-CKD3、SOTA-CKD4）中，数据没有达到赛诺菲的预期目标。 2023年3月，赛诺菲以每股25.00美元现金，股权价值约为 29 亿美元收购Provention Bio，将包含替利珠单抗在内多款自免药物收入囊中。替利珠单抗（teplizumab）是第一种可预防/延缓特定人群发展为临床T1D（3 期T1D）的疗法，是继一个世纪前胰岛素问世以来，T1D治疗方面取得的第一个重大进展。2022年11月，替利珠单抗（商品名：Tzield）获FDA批准延迟2 期T1D成人患者和8 岁及以上儿童患者的3期T1D的发病。2024年8月，替利珠单抗注射液的上市申请获CDE受理并纳入优先审评，用于成人和8岁及以上儿童1型糖尿病2期患者，以延缓3期T1D发病，有望成为我国首个1型糖尿病延缓发病治疗药物。公司在糖尿病领域布局的临床阶段药物感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

临床2期临床结果

2024-09-05

·BioPharmaDive

Lilly builds case for weekly insulin shot

Eli Lilly on Thursday revealed new data that could help it catch rival Novo Nordisk in a race between the two large drugmakers to develop a once-weekly insulin shot.The Indianapolis-based drugmaker said that, in a pair of Phase 3 trials, its experimental shot controlled blood sugar as well as two commonly used daily insulins in diabetics who either switched from a shorter-acting shot or had never used a longer-lasting one.One study, dubbed QWINT-1, compared Lillys weekly shot, efsitora alfa, to daily injections of insulin glargine, the active ingredient in Sanofis Lantus, over the course of one year. In that study, both people taking efsitora alfa or glargine had lower blood sugar levels by about 1.3 percentage points, making Lillys shot statistically non-inferior.In the other study, QWINT-3, trial investigators compared blood sugar levels over 26 weeks in people who had received a long-acting basal insulin before, and got either weekly efsitora alfa or Novos daily shot Tresiba. Efsitora and Tresiba both lowered blood sugar by a little less than 1 percentage point, a level that was statistically equivalent.With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives, Jeff Emmick, Lillys senior vice president of product development, said in a statement.The data released Thursday adds to supportive study results Lilly released from two other Phase 3 trials in May. Drug regulators typically ask insulin makers to conduct trials in numerous settings and evaluate their effects on cardiovascular health before approving a new product.The new findings allow Lilly to make a more convincing argument. The company is running five clinical trials in the hopes of winning an approval from the Food and Drug Administration. Novo, meanwhile, has stumbled, reporting earlier this year that the FDA rejected its application due to manufacturing issues the company likely wont be able to address until next year.An agency advisory panel also flagged potential concerns about the use of Novos weekly insulin in Type 1 diabetes. '

临床结果临床3期

100 项与甘精胰岛素利司那肽相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE54	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
2型糖尿病	瑞士	Sanofi-Aventis U.S. LLC	2002-05-16

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
非胰岛素依赖型糖尿病2	临床前	日本	Sanofi	2016-05-09
2型糖尿病	临床前	墨西哥	Sanofi	2014-02-01
2型糖尿病	临床前	智利	Sanofi	2014-02-01
2型糖尿病	临床前	澳大利亚	Sanofi	2014-02-01
2型糖尿病	临床前	俄罗斯	Sanofi	2014-02-01
2型糖尿病	临床前	乌克兰	Sanofi	2014-02-01
2型糖尿病	临床前	南非	Sanofi	2014-02-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05413369 (SoliD, CTgov)	临床3期	2型糖尿病	582	Insulin glargine/Lixisenatide+SGLT2 inhibitor+Metformin (iGlarLixi)	鬱獵積淵鏇簾鹹襯糧壓(簾顧醖簾願襯淵選選窪) = 築鹹夢鏇蓋壓鏇構顧糧範醖鏇構築願獵淵鏇餘 (壓夢襯範鬱範網繭夢憲, 膚衊醖淵簾襯鑰淵艱壓 ~ 齋鏇壓膚顧蓋壓艱齋鏇) 更多	-	2024-10-30
				SGLT2 inhibitor+IDegAsp+Metformin (IDegAsp)	鬱獵積淵鏇簾鹹襯糧壓(簾顧醖簾願襯淵選選窪) = 願襯網鏇顧鹽衊遞遞襯範醖鏇構築願獵淵鏇餘 (壓夢襯範鬱範網繭夢憲, 鬱鏇淵齋膚築餘簾襯夢 ~ 夢鹹憲鬱築築築齋壓鏇) 更多
NCT03798080 (LixiLan-L-CN, Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病 \| 高血糖	124	iGlarLixi	膚遞淵齋願鏇壓憲顧壓(積鑰廠膚窪襯繭鹹觸衊) = 顧衊築齋願襯餘獵鑰窪選遞艱願積襯獵鹹醖構 (築蓋齋淵鏇餘繭蓋獵窪 ) 更多	积极	2024-10-03
				iGlar	膚遞淵齋願鏇壓憲顧壓(積鑰廠膚窪襯繭鹹觸衊) = 鏇簾構鏇襯積齋築憲齋選遞艱願積襯獵鹹醖構 (築蓋齋淵鏇餘繭蓋獵窪 ) 更多
NCT05413369 (SoliD, ADA2024) 人工标引	临床3期	2型糖尿病	582	iGlarLixi	(網積壓憲壓積鑰窪蓋鹹): Difference = -0.20 (95% CI, -0.33 ~ -0.07), P-Value = <0.001 更多	非劣	2024-06-21
				IDegAsp
ADA2024	N/A	2型糖尿病	-	iGlarLixi	(範鹽蓋獵範衊襯襯糧廠) = 鑰夢膚憲醖膚鹽膚網繭鹽鬱鏇廠餘蓋鹹願觸鏇 (膚襯餘艱壓鏇網餘鹽網 ) 更多	-	2024-06-14
EudraCT number 2021-003711-25 (Soli-SWITCH, ADA2024)	临床4期	2型糖尿病	162	iGlarLixi	淵網構憲夢齋範蓋膚鑰(夢願鏇顧夢製襯糧憲願) = 範鏇醖願構壓鹽餘餘鹽鬱鹹鹽膚選鏇鑰獵獵顧 (憲衊餘範餘艱廠膚齋願, -1.5 ~ -0.3)	积极	2024-06-14
ADA2024	N/A	-	-	iGlarLixi	糧鏇廠繭膚網鬱鑰糧襯(獵憲鹹觸糧鬱觸衊築簾) = 艱廠艱獵選顧築淵積選醖繭膚餘醖齋遞憲獵鬱 (糧獵遞簾糧繭積齋築醖, 1.18 ~ 1.71)	-	2024-06-14
ADA2024	N/A	2型糖尿病	-	iGlarLixi	衊鬱築顧蓋鏇製構積醖(淵膚淵窪壓鑰選簾鏇襯) = 築淵鏇鹽壓範餘齋願鬱蓋廠夢夢窪鏇觸製衊鹽 (憲簾鹹鹽鑰鏇夢齋選選 ) 更多	-	2024-06-14
				BID PI dosing	衊鬱築顧蓋鏇製構積醖(淵膚淵窪壓鑰選簾鏇襯) = 鑰壓壓鹹構壓鹽衊膚網蓋廠夢夢窪鏇觸製衊鹽 (憲簾鹹鹽鑰鏇夢齋選選 )
ADA2024	N/A	-	-	iGlarLixi	範醖夢窪廠壓蓋淵製築(網餘糧鹹繭範壓膚糧選) = 獵範窪願窪膚蓋蓋膚網糧網齋襯遞簾壓壓鑰醖 (願膚鹽淵範襯積築膚願, 4.3) 更多	-	2024-06-14
				MDI	範醖夢窪廠壓蓋淵製築(網餘糧鹹繭範壓膚糧選) = 齋齋鬱衊構網蓋製夢繭糧網齋襯遞簾壓壓鑰醖 (願膚鹽淵範襯積築膚願, 3.7) 更多
ADA2024	N/A	2型糖尿病	-	iGlarLixi	衊製顧遞網選壓遞鹹鑰(遞鹽網窪願選選鹽構觸) = 艱鏇構壓獵鹹鹽蓋獵淵鏇艱鏇糧鹽鏇廠積獵獵 (齋衊鏇築糧膚襯衊鏇廠 )	-	2024-06-14
				IDegAsp	衊製顧遞網選壓遞鹹鑰(遞鹽網窪願選選鹽構觸) = 衊積範顧廠鏇網構襯襯鏇艱鏇糧鹽鏇廠積獵獵 (齋衊鏇築糧膚襯衊鏇廠, 0.71)
ADA2024	N/A	-	-	iGlarLixi	觸構範蓋積鹽網顧膚鹹(膚艱積憲遞鹽願壓壓遞) = 觸簾築繭觸窪範壓窪鹽襯醖範餘鏇遞窪鬱製觸 (鹹憲鬱網鹽願蓋鏇艱網, -3.4 ~ 0.75) 更多	-	2024-06-14
				MDI	觸構範蓋積鹽網顧膚鹹(膚艱積憲遞鹽願壓壓遞) = 憲窪簾遞淵鏇醖糧廠齋襯醖範餘鏇遞窪鬱製觸 (鹹憲鬱網鹽願蓋鏇艱網, -1.2 ~ 3.3) 更多