EFFICACY OF EARLY GLARGINE PLUS STANDARD IV INSULIN VERSUS STANDARD IV INSULIN IN PATIENTS WITH DIABETIC KETOACIDOSIS: A RANDOMISED CONTROLLED TRIAL - NIL

开始日期2024-09-30

申办/合作机构-

NCT06340854 / Recruiting临床3期

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

开始日期2024-04-19

申办/合作机构

Novo Nordisk A/S

NCT06619301 / Recruiting临床3期IIT

Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

开始日期2024-04-01

申办/合作机构

Loyola University Medical Center

100 项与甘精胰岛素相关的临床结果

登录后查看更多信息

100 项与甘精胰岛素相关的转化医学

登录后查看更多信息

100 项与甘精胰岛素相关的专利（医药）

登录后查看更多信息

2,106

项与甘精胰岛素相关的文献（医药）

2024-12-01·DIABETES OBESITY & METABOLISM

Efficacy and safety of once‐weekly insulin icodec versus once‐daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials

Article

作者: Kadowaki, Takashi ; Nishida, Tomoyuki ; Ásbjörnsdóttir, Björg ; Nishimura, Rimei ; Watada, Hirotaka ; Yamamoto, Yuiko ; Yamauchi, Toshimasa

Abstract:

Aim:

To explore the efficacy and safety of once‐weekly insulin icodec (icodec) in Japanese adults (≥20 years old) with type 2 diabetes from the global ONWARDS 1, 2 and 4 trials.

Materials and Methods:

Insulin‐naive (ONWARDS 1) and insulin‐experienced (ONWARDS 2 and 4) individuals were randomized to icodec or a once‐daily insulin comparator: insulin glargine U100 [ONWARDS 1 (basal insulin only) and 4 (basal–bolus regimen)] or insulin degludec [ONWARDS 2 (basal insulin only)]. The primary outcome was change in glycated haemoglobin from baseline to end of treatment (EOT) (ONWARDS 1: Week 52; ONWARDS 2 and 4: Week 26). Here, we present the Japanese subgroup results.

Results:

Similar reductions in glycated haemoglobin from baseline to EOT were observed in each trial for icodec and comparators. The proportion of time in range (blood glucose 3.9–10.0 mmol/L) at EOT was also comparable across treatment groups (time in range: 58%–68%), as was time spent with blood glucose below 3.0 mmol/L (<1.0%). Combined clinically significant (blood glucose <3.0 mmol/L) or severe (requiring external assistance for recovery) hypoglycaemia rates were low, with no severe events (ONWARDS 1 and 2) or a single severe event (ONWARDS 4; icodec group) reported. These results generally aligned with findings from the respective global populations. No new safety issues were identified.

Conclusions:

Icodec improved glycaemic control to a similar degree as once‐daily basal insulin comparators while maintaining low levels of clinically significant or severe hypoglycaemia. The findings support icodec use in Japanese individuals with different levels of type 2 diabetes progression.

2024-11-01·DIABETES CARE

A Glycemic Threshold Above Which the Improvement of β-Cell Function and Glycemia in Response to Insulin Therapy Is Amplified in Early Type 2 Diabetes: The Reversal of Glucotoxicity

Article

作者: Ye, Chang ; Emery, Alexandra ; Kramer, Caroline K. ; McInnes, Natalia ; Pu, Jiajie ; Harris, Stewart B. ; Zinman, Bernard ; Retnakaran, Ravi ; Reichert, Sonja M. ; Gerstein, Hertzel C.

OBJECTIVE:

Alleviation of unrecognized glucotoxicity, with resultant recovery of β-cell function, could amplify the glucose-lowering effect of pharmacotherapy and contribute to the variable therapeutic response observed among patients with type 2 diabetes (T2D). However, clinical evidence supporting this concept is lacking. Short-term intensive insulin therapy (IIT) can ameliorate glucotoxicity and improve β-cell function in early T2D. Thus, for evidence of recovery of glucotoxicity-associated β-cell dysfunction, we sought to determine whether there exists a baseline fasting glucose threshold above which the post-IIT improvement in both β-cell function and glycemia is amplified.

RESEARCH DESIGN AND METHODS:

IIT (glargine, lispro) was administered for 3 weeks to 108 adults with T2D (mean duration 1.8 ± 1.4 years). Oral glucose tolerance tests before and after IIT enabled assessment of β-cell function by Insulin Secretion-Sensitivity Index-2 and insulinogenic index/HOMA-insulin resistance. For each level of baseline fasting glycemia from 6.0 to 10.5 mmol/L, we modeled the difference in IIT-induced percentage change in β-cell function between those at/above the indicated glucose level and those below it.

RESULTS:

The relationship between baseline fasting glucose and the differential change in β-cell function was nonlinear. Instead, this relationship was best fit by a cubic regression model with inflection (amplification) at fasting glucose at 9.3 mmol/L. Moreover, baseline fasting glucose at 9.3 mmol/L also identified the inflection point at which nonlinear reductions in fasting glucose and 2-h glucose, respectively, were both amplified.

CONCLUSIONS:

The respective improvements in β-cell function and glycemia in response to short-term IIT are amplified in those in whom baseline fasting glucose exceeds a defined threshold, consistent with reversal of glucotoxicity.

2024-11-01·Lancet Diabetes & Endocrinology

Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1

Article

作者: Ásbjörnsdóttir, Björg ; Lingvay, Ildiko ; Bergenstal, Richard M ; Mader, Julia K ; Nishida, Tomoyuki ; Watt, Sara K ; Rosenstock, Julio

BACKGROUND:

Continuous glucose monitoring (CGM) can provide a comprehensive assessment of glycaemic control. This exploratory analysis of the ONWARDS 1 trial assessed CGM-based metrics and CGM-derived hypoglycaemia duration in insulin-naive individuals with type 2 diabetes treated with subcutaneous once-weekly insulin icodec (icodec) versus once-daily insulin glargine U100 (glargine U100).

METHODS:

ONWARDS 1 was a 78-week (52-week main treatment phase and a 26-week treatment extension phase plus a 5-week follow-up), randomised, open-label, treat-to-target, phase 3a trial done at 143 sites (outpatient clinics and hospital departments) across 12 countries. Adults (aged ≥18 years) with type 2 diabetes (HbA_1c: 7·0-11·0%) who had not previously received insulin were randomly assigned (1:1) via an interactive web-response system to once-weekly icodec or once-daily glargine U100. Double-masked CGM data were collected during treatment initiation (weeks 0-4), midtrial (weeks 22-26), end of main phase (weeks 48-52), end of extension phase (weeks 74-78), and follow-up (weeks 78-83). Secondary and exploratory outcomes were CGM-based metrics, including the mean percentages of time in glycaemic range (TIR; sensor glucose 3·9-10·0 mmol/L [70-180 mg/dL]), time in tight range (TITR; 3·9-7·8 mmol/L [70-140 mg/dL]), time above range (TAR; >10·0 mmol/L [>180 mg/dL]), and time below range (TBR; <3·9 mmol/L [<70 mg/dL] and <3·0 mmol/L [<54 mg/dL]), and CGM-derived hypoglycaemic episode durations (episodes defined by sensor glucose <3·9 mmol/L [<70 mg/dL for ≥15 consecutive minutes]). Analyses were done in the full analysis set (all randomly assigned participants). The ONWARDS 1 trial is registered with ClinicalTrials.gov, NCT04460885, and is complete.

FINDINGS:

Participants were enrolled and randomly assigned in ONWARDS 1 between Nov 25, 2020, and Dec 1, 2022 (n=492 in each treatment group). During treatment initiation, we observed no statistically significant differences in the mean percentages of TIR, TITR, TAR, and TBR with icodec versus glargine U100. During the midtrial, end of main phase, and end of extension phase periods, the mean percentages of TIR and TITR were statistically significantly greater and the mean percentages of TAR statistically significantly lower with icodec versus glargine U100. The mean percentages of TIR met the internationally recommended CGM target (>70%) with icodec but not with glargine U100 during the three periods. TBR (<3·9 mmol/L [<70 mg/dL] and <3·0 mmol/L [<54 mg/dL]) was low and below recommended targets (<4% and <1%, respectively) across all study periods in both treatment groups, with no statistically significant differences between treatment groups for the lower threshold (<3·0 mmol/L [<54 mg/dL]). During the follow-up period, mean percentages of TIR, TITR, TAR, and TBR did not statistically significantly differ with icodec versus glargine U100. The duration of overall hypoglycaemic episodes was similar between treatment groups throughout the trial (median duration ≤35 min).

INTERPRETATION:

These CGM data support the long-term efficacy and safety of icodec versus glargine U100 during treatment and indicated no increase in the duration of individual hypoglycaemic episodes with icodec versus glargine U100 in insulin-naive individuals with type 2 diabetes.

FUNDING:

Novo Nordisk.

376

项与甘精胰岛素相关的新闻（医药）

2024-11-06

·E药经理人

全球首个，中国同创！胰岛素周制剂诺和期®进博首展，月底上市

11月6日，第七届中国国际进口博览会（以下简称“进博会”）上，诺和诺德公司召开新闻发布会并宣布，在本届进博会首展的全球首个胰岛素周制剂诺和期®（依柯胰岛素注射液）将于2024年11月底在中国商业上市，用于治疗成人2型糖尿病，开启胰岛素治疗周制剂时代。诺和诺德在第七届进博会宣布全球首个胰岛素周制剂诺和期®11月底在中国上市上海交通大学医学院附属第一人民医院内分泌代谢科学科带头人彭永德教授表示：“胰岛素治疗直至目前仍是糖尿病管理路径中必不可少的重要基石，基础胰岛素作为关键组成，力求更好地满足临床治疗需求，以帮助患者及时起始治疗、改善治疗依从性，增加治疗持续性，提高患者满意度等1。” 01 胰岛素“从日到周”创新突破助力糖尿病患者血糖达标 100年前，胰岛素的发现让糖尿病从不治之症变为可控的疾病。100年间，胰岛素制剂经历了长足发展，其中通过多种方式延长基础胰岛素的作用时间，一直是研发创新的热点2,3。诺和诺德大中国区医药和质量部企业副总裁张克洲表示：“诺和诺德对使用脂肪酸酰化技术延长肽类药物半衰期有着丰富的经验和多个成功的产品。诺和期®基于脂肪酸酰化技术，可与白蛋白强效、可逆的结合，在人体内半衰期长达196小时，一周给药间隔内，依柯胰岛素降糖作用分布均匀，在临床相关剂量下，降糖作用时间可覆盖一周4，实现了基础胰岛素从日到周的百年突破。” 彭永德教授表示，依柯胰岛素全球3期临床试验ONWARDS系列研究，共纳入3765名2型糖尿病患者，验证了其良好的降糖疗效与安全性。与基础胰岛素日制剂i相比，可帮助更多2型糖尿病患者实现糖化血红蛋白<7%且无低血糖ii的治疗目标5,6,7,8，且显著改善患者治疗满意度和依从性5,8,9,10,11,12。 02 国内外同步创新进博宝宝将实现成长三级跳同时，诺和期®还是诺和诺德“中国同创”项目的首个落地成果，首次实现国内外创新药半年内几乎“零时差”获批，让中国患者更早获益于全球创新药。去年第六届进博会上，它曾以临床研究文献的形式展出，仅一年时间，就从文献变为展品，实现从展品到商品的成长“三级跳”。诺和诺德大中国区医药和质量部企业副总裁张克洲介绍：“进博会见证了‘中国同创’项目的成长，2019年，‘中国同创’项目启动，目标是实现创新药在中国与全球同步临床和获批。2020年，我们在进博会宣布项目进入2.0阶段；今年进博会，我们带来了首个落地成果。诺和期®实现‘中国同创、世界同期’的背后，体现了药品审评审批制度改革对创新的加速，以及中国临床研究能力的提升，更见证了中国临床研究创新‘从跟跑到领跑’的跨越。” 诺和诺德全球高级副总裁兼大中国区总裁周霞萍表示：“一个世纪以来，诺和诺德立足并不断深耕糖尿病治疗领域，引领科研突破，扩大公司药物可及性。我们在创新路上的每一步，都是为了患者充满希望地迈出下一步。今年是诺和诺德中国成立三十周年，我们非常自豪，在这一年实现了胰岛素周制剂国内外同步获批，为提升患者生活幸福感又进一步。”她还指出，“参展进博七年，诺和诺德有多款进博宝宝从四叶草走进中国大市场。未来我们将继续加速创新，深化合作，造福更多患者。” 注： i. 基础胰岛素日制剂，包括甘精胰岛素U100/U300和德谷胰岛素 ii. 低血糖：有临床意义的低血糖或严重低血糖参考文献： 1. Tien KJ, et al. J Diabetes Investig. 2019 May;10(3):560-570. 2. Buse JB, et al. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002373. 3. Heise T, et al. Diabetes Obes Metab. 2017 Jan;19(1):3-12. 4. Nishimura E, et al. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002301. 5. Bajaj H. 2023 ADA Scientific Sessions. 803-P; 6. Rosenstock J, et al. N Engl J Med 2023; 389:297–308. 7. Lingvay I, et al. JAMA 2023; 330:228–237 8. Philis-Tsimikas A et al. Lancet Diabetes Endocrinol. 2023;11(6):414-425. 9. Brod M, et al. Health Qual Life Outcomes. 2009 Sep 9;7:83. 10. Bajaj HS, et al. Ann Intern Med. 2023 Nov;176(11):1476-1485. 11. Goldenberg R et al. 2023 EASD Annual Meeting. SO-776. 12. Polonsky W, et al. EASD 2023 Annual Meeting. SO-780. 一审| 黄佳二审| 李芳晨三审| 李静芝

临床3期上市批准临床结果申请上市

2024-10-28

·GBIHealth

赛诺菲Y24Q3财报速读：制药业务收入121.67亿欧元，中国市场增长3.6%

2024年10月25日，赛诺菲发布了2024年第三季度财务业绩。2024年第三季度（报告期），公司收入134.38亿欧元（约145.47亿美元），同比增长15.7%（按固定汇率计算，下同）。制药业务收入121.67亿欧元，中国市场增长3.6% 制药业务收入121.67亿欧元，同比增长16.6%；消费者保健业务Opella收入12.71亿欧元，同比增长7.9%。 2024年前三季度，公司收入达346.47亿欧元（约375.11亿美元），同比增长11.1%。制药业务增长强劲，主要由达必妥（度普利尤单抗）和疫苗驱动。报告期内（2024年第三季度），达必妥销售额34.76亿欧元，同比增长23.8%；达必妥前三季度销售额达96.14亿欧元，同比增长25.9%。公司预测，2024年全年，达必妥销售收入可达130亿欧元。报告期内，疫苗销售额38.02亿欧元，同比增长25.5%。其中，RSV疫苗Beyfortus（尼塞韦单抗）销售额增长381.8%达6.45亿欧元。报告期内，新上市药品收入7.27亿欧元，同比增长67.1%，主要由血友病疗法ALTUVIIIO（+278.3%）、庞贝病酶替代疗法Nexviazyme/Nexviadyme（+53.6%）等驱动。报告期内，其他药品销售收入41.62亿欧元，同比增长0.4%。按市场分美国市场收入68.86亿欧元，同比增长23.6%；欧洲市场收入28.86亿欧元，同比增长6.6%；其他市场收入36.66亿欧元，同比增长10.3%。中国市场收入增长3.6% 2024年第三季度，中国市场收入7.57亿欧元（约8.19亿美元），同比增长3.6%，主要由达必妥的强劲销售驱动，但又被依诺肝素（受VBP影响）和其他药品的销售低迷抵消。中国市场也驱动贝舒地尔、胰岛素来优时（甘精胰岛素）全球销售额分别增长57.8%和18.1%。波立维尽管在中国市场已进入带量采购，但由于应用范围持续扩大，推动全球销售增长8.3%。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报疫苗带量采购

2024-10-18

·药智网

胰岛素龙头全面出击

近日，国内胰岛素龙头企业甘李药业发布公告，三款1类创新药物GZR18注射液、GZR4注射液与GZR101注射液在II期临床研究中达到主要终点。十月秋风送爽，满园瓜果飘香。甘李药业作为国内第一家工业化生产胰岛素的企业，自诞生之初就将研发刻在了基因里。此次公告亮点极多，3款第四代降糖药物的临床成功，将实现糖尿病患者的全病程覆盖——体现了甘李药业在糖尿病领域的深厚研发实力。又全又快，四代新品全面覆盖图片来源：甘李药业甘李药业在三代胰岛素类似物上深耕多年，随着GZR18、GZR4和GZR101这3款第四代降糖药物的临床成功，将实现糖尿病患者的全病程覆盖——放眼全球，仅有诺和诺德和甘李具备这个能力。值得一提的是，三代胰岛素类似物的代表来得时（甘精胰岛素）和诺和锐（门冬胰岛素）分别于2000年和1999年在全球上市，而直到2020年，甘李才完成了国产首款门冬胰岛素生物类似药（锐秀霖）的上市。而如今，诺和诺德四代胰岛素周制剂Icodec（依柯胰岛素）于今年才在欧洲上市，甘李药业此举，成为中国首个且是唯一一个完成胰岛素周制剂2期临床的创新药企。从20年的差距到如今不足5年，以甘李药业为代表的中国药企，正在以实际行动逐渐追上乃至赶超全球老牌药企的研发步伐。头对头， GZR18击败司美格鲁肽根据国家临床试验登记平台的信息显示，甘李药业GZR18是第一个敢于与司美格鲁肽在2型糖尿病患者上进行头对头试验的产品。司美格鲁肽作为划时代的GLP-1受体激动剂产品，其2023年全球销售额（Ozempic，2型糖尿病适应症）已达139亿美元。而GZR18已经能够实现1月2次给药，在大大提高了糖尿病患者依从性的同时，药效优于每周一次的司美格鲁肽，实现了对司美格鲁肽的超越。目前，GLP-1受体激动剂的市场远未饱和，GZR18有望在百亿GLP-1市场中取得瞩目成绩。糖化血红蛋白（HbA1c）的降幅是衡量降糖药物疗效的金标准。在中国2型糖尿病患者中进行的GZR18注射液与司美格鲁肽的头对头II期临床研究显示，GZR18在糖尿病初治患者中可降低糖化血红蛋白2.98%。该数据超过了全球范围内所有已发表的同类药物单药治疗文献数据，为全球最佳（司美格鲁肽、替尔泊肽、玛仕度肽该项数据为1.55%，2.07%，2.15%），甚至超过了同类药物与其它降糖药物联合使用的降糖效果。这也意味着糖化血红蛋白在10%以上的患者可以通过GZR18单药治疗，将糖化血红蛋白降低至控制目标，有望改写新诊断糖尿病患者的诊疗路径，具有十分重大的意义。期待甘李药业后续对GZR18的开发计划，能够真正造福糖尿病患者。结合前段时间披露的减重数据，GZR18作为单靶点GLP-1类药物，1月2次给药，可实现糖化血红蛋白降低超过2%，减重有望超过20%，引领GLP-1类药物全面进入2.0时代。 GZR18的成功也引发了另一个讨论：以GLP-1 RA为基础的药物，有没有必要设计成多靶点？或者多靶点较单靶点的额外获益是否多于不良反应？以替尔泊肽为例，其展现出GLP-1和GIP交叉免疫原性，并看到了更高的超敏反应和注射部位不良反应，而多靶点带来的额外获益却常难以撇清GLP-1R激活的贡献，成了一笔糊涂账。这非常类似于卡格列净同时作用于SGLT-2受体和SGLT-1受体，若想声称独特肠道降糖效果，首先需回答心脏安全性问题。时至今日，GLP-1RA为基础的药物研发优选方向又分成两条赛道：是在单靶点上突破GZR18降糖减重和给药频率三方位的天花板，还是在靶点数量上继续刷新？ “1”>“7”？ GZR4疗效优于德谷胰岛素正面解读不容易被理解，反面解读很通俗易懂：与GZR4相比，打德谷胰岛素是否白打了六天？糖尿病是不断进展的，当患者胰岛功能逐渐丧失，胰岛素走入患者生活后，他们的治疗方案将会变成日复一日频繁的注射与每日三餐随餐药物的治疗，意味着这将强行在患者的作息表中圈出密密麻麻的服药时间。与此如影随形般伴随的是腹部轮换注射留下的、患者自己也数不清楚的一圈圈的注射位点以及由此带来的疾病隐私的暴露与倍增的病耻感。而胰岛素周制剂的最主要贡献，就是把胰岛素注射安排的日子从日历划掉大半。在具体数据上，在胰岛素经治患者中，GZR4较德谷胰岛素优效。目前，对胰岛素周制剂的顾虑就在于少打六天，是否会影响药效。临床数据表明，从基础胰岛素日制剂转换成GZR4，患者的血糖水平能得到进一步控制。同时，从文献数据可知，诺和诺德依柯胰岛素的药效与德谷胰岛素持平，表明GZR4可能具备优于依柯胰岛素降糖效果的潜力。因此，回应本段开头的问题：不是白打了六天，而是GZR4将有能力赋予患者豁免这六针的权利，为已经进展至胰岛素治疗阶段的糖尿病患者带来全新的糖尿病治疗体验。更上一层楼： GZR101的双胰岛素革命糖尿病进展至胰岛功能严重不足时，患者需要补充的胰岛素不仅有基础部分，还包括餐时部分。 2针预混胰岛素或1+3（1针基础，3针餐时）是常用的治疗方案，此时患者的治疗负担进一步加剧。当患者已经只能通过每天注射控制血糖的时候，如何“少打一针”就成了最关键的课题。 GZR101是基础胰岛素GZR33和门冬胰岛素的复方制剂，既能有效管理空腹血糖，又能对当餐餐后血糖进行很好的控制。目前，双胰岛素制剂中最成功的产品当属诺和佳（德谷门冬双胰岛素），它解决了预混胰岛素的混匀异质性问题，具备更稳定持久的降糖效果，在中国2023年销售额已经超过20亿元人民币，但并未在美国上市销售。 GZR101是中国首个与诺和佳进行头对头临床试验的创新药产品，从临床设计上和数据上看，GZR101优于每日1针或2针诺和佳，意味着GZR101有望成为超越诺和佳的下一代产品。结语：在企业和资本疯狂追逐肥胖市场的今天，糖尿病患者，尤其是胰岛素使用患者的治疗需求被严重忽视，甚至不少企业已经放弃对GLP-1受体激动剂糖尿病适应症的开发。而经历胰岛素集采风波，价格大跳水带来的利润断崖式下跌的甘李药业，历经三年走出阴霾后，却仍然坚守着对糖尿病患者的承诺以及药物开发的初心。这种对患者治疗需求的深刻理解和追求科学极致的精神淋漓尽致地体现了中国胰岛素之父的情怀和抱负。若一束光让夜更向黎明，那是纪元。声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 瑟吉欧阅读原文，是受欢迎的文章哦

临床2期生物类似药临床3期

100 项与甘精胰岛素相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03250	甘精胰岛素	A10AE04	DB00047

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
糖尿病	欧盟	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	冰岛	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	列支敦士登	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	挪威	Sanofi-Aventis Deutschland GmbH	2000-06-09
1型糖尿病	美国	Sanofi-Aventis U.S. LLC	2000-04-20
2型糖尿病	美国	Sanofi-Aventis U.S. LLC	2000-04-20

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
急性心肌梗塞	临床3期	美国	Sanofi	2008-04-01
急性心肌梗塞	临床3期	阿根廷	Sanofi	2008-04-01
急性心肌梗塞	临床3期	巴西	Sanofi	2008-04-01
急性心肌梗塞	临床3期	加拿大	Sanofi	2008-04-01
急性心肌梗塞	临床3期	墨西哥	Sanofi	2008-04-01
糖尿病昏迷	临床3期	美国	Sanofi	2008-04-01
糖尿病昏迷	临床3期	阿根廷	Sanofi	2008-04-01
糖尿病昏迷	临床3期	巴西	Sanofi	2008-04-01
糖尿病昏迷	临床3期	加拿大	Sanofi	2008-04-01
糖尿病昏迷	临床3期	墨西哥	Sanofi	2008-04-01

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


NCT03406000 (TOP1, Pubmed)	临床4期	1型糖尿病	-	Twice-daily basal insulin	膚鑰廠餘遞選鬱窪顧觸(簾構選顧壓膚衊遞廠積) = 簾製選襯構網構壓觸餘膚膚鑰構製願繭鏇壓鏇 (獵遞淵鑰鹽鏇觸襯範顧 ) 更多	积极	2024-07-09
NCT01524705 (FLAT-SUGAR, CTgov)	临床4期	2型糖尿病	102	Insulin Glargine+Exenatide+Metformin	積餘艱醖構遞窪襯齋繭(艱齋遞鏇憲繭觸獵窪築) = 糧鑰廠鹹簾鏇襯顧醖獵鑰糧夢選鏇蓋製選夢齋 (廠獵廠顧壓鹽餘製顧淵, 鏇鬱構艱積獵網鏇衊範 ~ 艱積衊衊醖壓膚鹽鬱鹹) 更多	-	2023-12-29
EASD2023	N/A	2型糖尿病	-	Insulin glargine 300 U/mL (Gla-300)	淵網鏇製淵餘膚願醖顧(構鬱餘積鏇鬱艱簾獵觸) = 廠鹹鬱願遞夢獵餘蓋遞醖淵壓衊壓鬱衊願餘選 (夢觸顧衊鑰鹹簾艱獵築 )	-	2023-10-05
				Long-acting basal insulins (BIs)/NPH insulin	淵網鏇製淵餘膚願醖顧(構鬱餘積鏇鬱艱簾獵觸) = 膚廠觸膚鑰構淵壓憲衊醖淵壓衊壓鬱衊願餘選 (夢觸顧衊鑰鹹簾艱獵築 )
ORIGIN (ESC2023)	N/A	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	獵鬱鏇醖築範夢鏇淵齋(壓醖廠餘餘選蓋夢廠鏇) = 簾糧選製憲糧憲蓋積餘廠壓壓簾齋範鏇夢艱鬱 (醖壓鹽餘齋鏇鏇構積鬱 )	-	2023-08-26
				Glargine	獵鬱鏇醖築範夢鏇淵齋(壓醖廠餘餘選蓋夢廠鏇) = 艱鹹蓋顧觸糧艱網淵積廠壓壓簾齋範鏇夢艱鬱 (醖壓鹽餘齋鏇鏇構積鬱 )
RESTORE-G (ADA2023)	N/A	-	-	Glargine 300 U/mL	繭遞餘鏇憲鹹構餘鏇願(顧願艱鏇積襯膚選壓膚) = 壓淵遞糧廠憲糧築鹽齋鹽鹽顧網網壓構鹽鬱觸 (夢膚醖簾壓淵衊膚鏇壓 )	-	2023-06-23
ADA2023	N/A	-	-	Bridging dose of G with first dose of D	繭壓顧構網衊鹽構夢鬱(遞構窪壓夢廠蓋窪選糧) = 願鹽鏇顧製膚蓋憲簾構繭製鑰窪夢築簾顧選鏇 (蓋構夢網範淵窪範築艱 )	-	2023-06-20
				Placebo	積蓋糧鹽淵製膚憲憲壓(膚艱網獵壓膚鹹獵窪鑰) = 鑰選衊顧顧襯窪鏇網獵製繭鹹鑰窪網糧範構廠 (鹽鑰鹽艱廠網觸蓋窪憲 )
GRADE (ASN2022)	N/A	2型糖尿病	-	Sitagliptin	齋壓糧壓築衊窪鏇壓繭(膚獵鏇艱窪製繭製廠窪) = 願衊膚壓鬱願膚鏇觸願齋顧鏇顧餘鑰鹹願艱鬱 (願鹹糧齋壓願糧築鏇齋, -2.20 ~ -1.86)	不佳	2022-11-03
				Glimepiride	齋壓糧壓築衊窪鏇壓繭(膚獵鏇艱窪製繭製廠窪) = 餘壓糧獵艱窪蓋衊製範齋顧鏇顧餘鑰鹹願艱鬱 (願鹹糧齋壓願糧築鏇齋, -2.08 ~ -1.75)
NCT03703869 (ATOS, EASD2022)	N/A	2型糖尿病	3,651	insulin glargine 300 U/mL	遞願網顧糧衊衊廠淵鬱(顧蓋遞構製鹹簾壓鏇艱) = 遞蓋衊遞鹹鹹繭遞蓋鹽蓋壓鬱餘壓築鏇顧築襯 (鏇積醖憲淵選壓網簾鏇 ) 更多	积极	2022-09-20
				insulin glargine 300 U/mL	遞願網顧糧衊衊廠淵鬱(顧蓋遞構製鹹簾壓鏇艱) = 範鹹餘廠糧廠鹽衊齋餘蓋壓鬱餘壓築鏇顧築襯 (鏇積醖憲淵選壓網簾鏇 ) 更多
NCT04567225 (CTgov)	临床4期	糖尿病酮症酸中毒 \| 2型糖尿病 \| 1型糖尿病	39	IV insulin infusion+Early Glargine (Early Glargine)	齋蓋積遞鑰壓製襯遞淵(醖鏇襯遞鏇糧繭壓艱鏇) = 淵網襯窪網製廠衊衊製鏇憲範壓鹹築製醖繭鹽 (蓋憲積蓋顧製廠簾蓋遞, 繭襯築膚憲襯範窪製積 ~ 鬱鹽鏇淵夢鏇繭醖獵餘) 更多	-	2022-08-25
				IV insulin infusion+Late Glargine (Standard Practice (Late Glargine))	齋蓋積遞鑰壓製襯遞淵(醖鏇襯遞鏇糧繭壓艱鏇) = 膚艱蓋襯襯艱遞顧餘蓋鏇憲範壓鹹築製醖繭鹽 (蓋憲積蓋顧製廠簾蓋遞, 構鬱範積鬱願衊觸顧醖 ~ 願壓積願製網齋鏇築獵) 更多
ADA2022	N/A	-	-	Insulin Glargine 100 U/mL (Gla-100)	壓齋壓鹹餘糧願網餘膚(願廠艱遞網遞選鏇憲築) = 夢餘襯齋艱艱壓築壓憲願淵簾選廠構製壓憲餘 (醖鏇顧壓鑰範顧選餘鏇 )	积极	2022-06-01
				Insulin Glargine 300 U/mL (Gla-300)	壓齋壓鹹餘糧願網餘膚(願廠艱遞網遞選鏇憲築) = 獵觸鑰窪衊襯艱製糧鹽願淵簾選廠構製壓憲餘 (醖鏇顧壓鑰範顧選餘鏇 )