A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Use of Insulin Icodec in People Living With Type 1 Diabetes

The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.

开始日期2025-09-01

申办/合作机构

Novo Nordisk A/S

NCT07112339

/ Recruiting临床4期

EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice

This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.

开始日期2025-08-15

申办/合作机构

Novo Nordisk A/S

NCT07076199

/ Recruiting临床3期

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

开始日期2025-08-11

申办/合作机构

Novo Nordisk A/S

100 项与依柯胰岛素相关的临床结果

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100 项与依柯胰岛素相关的转化医学

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100 项与依柯胰岛素相关的专利（医药）

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114

项与依柯胰岛素相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada

Article

作者: Mau, Godfrey ; Garcia, David A. ; Singh, Sumeet ; Spence, Michaela ; Goldenberg, Ronald ; Jensen, Morten Sall

AIM:

Patients with type 2 diabetes (T2D) with poor glycemic control despite use of non-insulin agents can experience delay in initiating insulin therapy and poor adherence to insulin therapy, predominantly due to the burden of multiple injections^1-3. This study aimed to determine the cost-effectiveness of insulin icodec, first once-weekly basal insulin, compared with long-acting basal insulins for improving glycemic control in adults with T2D in Canada.

MATERIALS AND METHODS:

The Swedish Institute of Health Economics T2D Cohort Model was used to analyse three T2D groups: insulin naïve (IN), basal insulin experienced (BIE), and basal-bolus insulin experienced (BBIE). Comparators included insulin glargine, insulin detemir, and insulin degludec. Comparative efficacy was informed by the phase 3 ONWARDS trials of insulin icodec and network meta-analyses (NMA). Time horizon was 40 years. Analyses considered disutilities resulting from vascular complications, age, gender, diabetes duration, hypoglycemia, and injection burden. A 1.5% annual discount rate was used for costs and effects. The average cost per unit for each treatment, accounting for the market share of available formats and biosimilars was calculated. Outcomes were expressed as quality-adjusted life-years (QALYs) and cost-effectiveness as incremental cost utility ratios (ICUR [cost/QALY]).

RESULTS:

In all analyses, insulin icodec dominated insulin degludec and insulin detemir. Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and $45,433 in the IN, BIE, and BBIE populations, respectively.

LIMITATIONS:

Limitations of this economic evaluation include the lack of data for some treatments in certain NMAs, uncertainty regarding the use of the NMA results for a 40-year time horizon, heterogeneous sources of disutilities, and uncertainty regarding the HRQoL benefits of reduced injection frequency.

CONCLUSIONS:

Insulin icodec is a cost-effective treatment option for adult patients with T2D versus once daily basal insulin-analogues publicly reimbursed in Canada.

2025-10-16·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Efficacy and Hypoglycemia Profile of Once-weekly Insulin Icodec vs Once-daily Comparators Across Demographic Subgroups

Article

作者: Desouza, Cyrus V ; Vianna, André G D ; Navarria, Andrea ; Lingvay, Ildiko ; Bache, Julie Krogsdahl ; Shaikh, Shehla S ; Fragão-Marques, Mariana

Abstract:

Objective:

This post hoc analysis evaluated the impact of age, ethnicity, and race on efficacy and hypoglycemia outcomes with once-weekly insulin icodec (icodec) vs once-daily (OD) basal insulin comparators, leveraging data from the ONWARDS 1 to 5 phase 3a clinical trials.

Methods:

Efficacy and hypoglycemia outcomes were assessed within each trial in insulin-naive (ONWARDS 1, 3, and 5) and insulin-experienced (ONWARDS 2 and 4) adults (≥18 years) with type 2 diabetes across subgroups of age (<55, 55-64, and ≥65 years), ethnicity (Hispanic/Latino and non-Hispanic/Latino), and race (Asian, Black/African American, White, Other). The primary outcome was the change in glycated hemoglobin (HbA1c) from baseline to planned end of treatment. Other outcomes assessed included the achievement of HbA1c <7% (<53 mmol/mol) without clinically significant or severe hypoglycemia and the number of clinically significant or severe hypoglycemic episodes.

Results:

Across all trials, the estimated treatment differences for change in HbA1c and the odds ratios for achieving HbA1c <7% (<53 mmol/mol) without clinically significant or severe hypoglycemia were similar across age, ethnicity, and race subgroups with icodec vs OD insulin (no statistically significant treatment by subgroup interactions were observed; P > .05 in all instances). Hypoglycemia rates were numerically low for both treatment groups and consistent across age, ethnicity, and race subgroups.

Conclusion:

The efficacy and hypoglycemia profile of icodec vs OD comparators was consistent across trial populations irrespective of age, ethnicity, or race.

2025-10-01·DIABETES OBESITY & METABOLISM

Adherence to app‐based dose guidance for once‐weekly insulin icodec in insulin‐naive individuals with type 2 diabetes: Post hoc analysis of ONWARDS 5

Article

作者: Lingvay, Ildiko ; Bennedsen, Lars Villads ; Martiny, Johannes Handberg Juul ; Bajaj, Harpreet S. ; Donatsky, Anders Meller ; Vianna, André

Abstract:

Aims:

In ONWARDS 5 (NCT04760626), a 52‐week, Phase 3a trial in insulin‐naive type 2 diabetes, 542/1085 participants were randomized to once‐weekly insulin icodec with a dosing guide app to assist titration (icodec with app). This post hoc analysis of the icodec with app group assessed titration behaviours and associations between app‐based dose guidance adherence and outcomes.

Materials and Methods:

App‐based dose guidance and manual overrides were assessed. App guidance adherence was defined as dose guidance being requested and followed, and that automatic dose titration was possible; adherence subgroups were defined by mean fraction of weeks adherent across all weeks with app usage (per 4 weeks: ‘low’, ≤1 [n = 52]; ‘medium’, >1–≤3 [n = 215]; ‘high’, >3 [n = 239]). Observed glycated haemoglobin (HbA1c; baseline to week 52) and hypoglycaemia were described. Modelling analyses assessed associations between app adherence and estimated pre‐breakfast self‐measured blood glucose (SMBG) and weekly insulin dose.

Results:

Few administered icodec doses (1053/21 244; 5.0%) differed from app guidance (dose changed by participant). Across 541 participants with app data, 56.7% had ≥1 app guidance override by a health care professional; most overrides (81.9%) were increases to app‐recommended dose. Observed mean HbA1c decreased from baseline across all adherence subgroups. Across 52 weeks of app use, ‘medium’ and ‘high’ versus ‘low’ adherence was associated with significantly lower estimated mean pre‐breakfast SMBG and higher estimated mean weekly insulin dose (both p < 0.0001). Clinically significant hypoglycaemia rates were low across subgroups, with no severe hypoglycaemia observed.

Conclusions:

Greater adherence to app‐based dose guidance was associated with greater estimated improvements in pre‐breakfast SMBG and higher weekly insulin dose. Trends indicated HbA1c improvements in all adherence subgroups. Findings support app use for real‐world insulin titration.

206

项与依柯胰岛素相关的新闻（医药）

2025-09-29

·PRNewswire

Novo Nordisk resubmits Awiqli® to the FDA with potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes

Awiqli® (insulin icodec) injection, if approved, has the potential to be the first once-weekly basal insulin treatment available in the US for adult type 2 diabetes In adults with type 2 diabetes, the ONWARDS clinical trial program evaluated the change in A1C from baseline with Awiqli® compared to daily basal insulin1-5 Resubmission reflects Novo Nordisk's 100-year legacy of advancing diabetes care BAGSVÆRD, Denmark and PLAINSBORO, N.J., Sept. 29, 2025 /PRNewswire/ -- Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes. "With this resubmission, we're closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk. "It is critical that we continue to build upon our 100-year legacy in diabetes and long-standing mission to advance science and the ONWARDS clinical program supports our hope that Awiqli® can help streamline the basal insulin injection regimen for people living with type 2 diabetes." The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5 About Awiqli® In the US, Awiqli® is an investigational, novel once-weekly basal insulin analog designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. This resubmission is in response to the FDA's action letter received in Q3 2024. Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information References Rosenstock J, Bain C. S, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. The New England Journal of Medicine. 2023 10.1056/NEJMoa2303208 Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 (23)00093-1 Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023 Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 (23)00520-2 Bajaj H, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naïve Type 2 Diabetes (ONWARDS 5). Annals of Internal Medicine. 2023 10.7326/M23-1288 Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25AWQ00001. September 2025 SOURCE Novo Nordisk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床2期

2025-09-22

·国际糖尿病idiabetes

重磅发布！依柯胰岛素临床应用专家指导建议出炉，通讯作者母义明教授深度解析

点击“蓝字”关注我们编者按自去年在中国上市以来，基础胰岛素周制剂依柯胰岛素已受到广大临床医生和2型糖尿病（T2DM）患者的青睐。为规范其临床应用、充分发挥其临床价值，《基础胰岛素周制剂依柯胰岛素治疗2型糖尿病临床应用专家指导建议（2025版）》（以下简称“专家指导建议”）近日正式发表于《中华糖尿病杂志》[1]。本刊特邀该专家指导建议的通讯作者之一，同时也是依柯胰岛素3期临床ONWARDS 3研究的leading PI之一——解放军总医院第一医学中心母义明教授，对该指导性文件进行深入解读，以期为临床实践提供专业指导。《国际糖尿病》请您结合临床实践，谈谈目前我国T2DM治疗仍面临哪些亟待突破的困境？母义明教授：我国糖尿病防治仍面临多项挑战。首先，未诊断比例居高不下，2013年新诊断患者占糖尿病患者总数的62%，2015~2017年该比例略降至54%，但在2018~2019年又回升至63.3%[2]。其次，糖尿病患病率持续上升，由2013年的10.9%增至2018~2019年的12.4%[2]。与此同时，糖尿病的知晓率、治疗率和控制率改善缓慢。2010年和2013年两次大规模调查显示，知晓率分别为30.1%和36.5%，治疗率分别为25.8%和32.2%，控制率分别为39.7%和49.2%[2]。而2018~2019年的数据显示，这3项指标分别为36.7%、32.9%和50.1%，与2013年相比几乎没有变[2]，仍无法达到糖尿病防控需求。超重和肥胖人群的糖尿病患病率显著增高。多次调查显示，体重指数（BMI）<25 kg/m2人群的糖尿病患病率从6.9%增至8.8%，BMI 25~30 kg/m2人群患病率维持在14%左右，BMI≥30 kg/m2人群患病率始终接近20%，提示肥胖是糖尿病的重要危险因素[2]。糖尿病也给患者和社会带来沉重的经济负担。2017年医保抽样数据显示，26万糖尿病患者年均个人医疗支出约1.8万元（含住院），医保人均支付超过4万元，凸显其显著的卫生经济学压力[3]。《国际糖尿病》当前胰岛素使用中，存在哪些未被满足的临床需求？胰岛素周制剂的出现，主要能够解决哪些临床实际问题？母义明教授：胰岛素在糖尿病治疗中具有不可替代的重要性。在T2DM中，早期胰岛素治疗有助于改善血糖控制、恢复胰岛β细胞功能，并带来远期心血管获益。然而，我国胰岛素治疗仍存在未满足的需求，包括起始延迟、剂量调整不足及患者依从性低等问题。而T2DM患者起始胰岛素治疗延迟容易导致血糖长期不达标，每日注射的复杂性进一步影响了治疗依从性。胰岛素周制剂作为新型长效基础胰岛素，将注射频率降至每周一次，在保持与日制剂相当的降糖疗效和安全性的同时，大幅减少注射次数。这不仅减轻患者注射痛苦、降低注射装置费用，还有助于显著提高治疗依从性，为临床提供更简便的治疗选择，有望提升整体血糖达标率。《国际糖尿病》请您谈谈药物研发时中国加入全球同创，药物上市后中国制定本土化指导建议的重要意义？如何实现从临床研究到临床指南的转化？母义明教授：全球同步研究是创新药物研发的重要组成部分，有助于使更多患者同步获得创新治疗，提升药物可及性并促进公共卫生水平发展。中国作为糖尿病大国，患者人数超过1.4亿，对更简便有效的降糖药物需求迫切。我们乐见全球创新药物尽早进入中国，以惠及广大患者。以诺和诺德“中国同创”计划为例，该计划积极推动中国融入全球同步临床研究体系，实现从临床试验到新药申报的全球同步协调，不仅使中国患者同步受益于全球创新药物，也通过加强科研合作提升了中国临床研究体系的整体能力。药物上市后制定本土化指导建议具有重要意义。中国T2DM患者与西方人群存在差异，本土化建议能基于中国人群证据提供更贴合临床的治疗策略，指导合理用药，提升医疗质量。详细可操作的指南有助于规范诊疗行为，缩小地区间差距，促进健康公平。专家共识则是对指南的重要补充，重点解决“如何操作”的问题，促进知识转化与实践应用[4]。以依柯胰岛素的ONWARDS 3研究[5]为例，这是中国首次参与胰岛素周制剂的全球同步临床试验，支持了该药在全球及中国的同步上市申报，极大加快了国内获批进程。该药于去年6月在中国上市，随后被纳入《中国糖尿病防治指南（2024版）》，充分体现了从临床研究到指南应用的快速转化，对糖尿病诊疗实践具有积极推动作用。此次专家指导建议的发表，则进一步细化了依柯胰岛素的临床应用要点，为临床医生提供了更具体、可操作的实施规范，有助于进一步提升T2DM患者的治疗质量。《国际糖尿病》基于专家指导建议，依柯胰岛素的创新性是什么？能为T2DM患者带来哪些获益？临床实际应用中需特别关注什么？母义明教授：在创新性方面，依柯胰岛素是一种长效胰岛素类似物，其结构经修饰后去除B30苏氨酸，并在B29赖氨酸上连接20碳脂肪酸侧链，同时替换3处氨基酸，从而增强与白蛋白的可逆结合、减缓清除并提高稳定性[6,7]。该药在循环中与白蛋白结合形成无活性储库，仅少量游离部分发挥降糖作用，实现平稳持续的血糖控制。依柯胰岛素半衰期长达196小时，每周一次给药，约3~4周达稳态，降糖效应在一周内分布均匀[7,9]。其暴露量不受人群特征（包括肝肾功能损害者）、注射部位或血清白蛋白水平的影响，低血糖风险与甘精胰岛素U100相当[9-11]。在临床获益方面，在T2DM患者中开展的3a期系列研究ONWARDS 1~5[5,12-15]显示，依柯胰岛素在口服药控制不佳者起始治疗或由基础胰岛素日制剂转换治疗中，可降低HbA1c达0.93%~1.68%，疗效非劣于甚至多数研究中优于基础胰岛素日制剂；其低血糖发生率及体重变化与对照组相当，多数研究中有临床意义或严重低血糖发生率均低于1事件/患者年。此外，该药显著减轻注射负担并提高治疗满意度，93.7%患者倾向选择依柯胰岛素，主要原因为注射频次少、使用方便和血糖控制更优。关于适用人群，依柯胰岛素适用于需基础胰岛素治疗的成人T2DM患者，包括口服药治疗3个月HbA1c未达标者可起始联用，以及已使用基础胰岛素日制剂者若空腹血糖达标但希望减少注射次数，或仍未达标需优化血糖控制者可转换使用。关于使用方法，口服降糖药血糖控制不佳的患者起始依柯胰岛素治疗时，推荐起始剂量为70 U每周1次，相当于每日基础胰岛素10 U每日1次。起始剂量也可参照基础胰岛素日制剂的常用方法：一般以每日0.1~0.2 U/kg，HbA1c>8.0%者可考虑每日0.2~0.3 U/kg，BMI ≥ 25 kg/m2者可考虑每日0.3 U/kg。依柯胰岛素周制剂的剂量可按基础胰岛素日剂量×7计算，并应根据患者低血糖风险及当前血糖与控制目标的差异进行个体化调整。已使用基础胰岛素日制剂治疗的患者转换依柯胰岛素治疗时，若空腹血糖已达标且希望减少注射次数，可按当前每日总剂量×7转换为依柯胰岛素每周1次治疗；若空腹血糖未达标，建议第1周在当前每日总剂量×7转换的基础上于首次注射时增加50%的额外剂量，以便更快实现血糖控制，且不增加低血糖风险，也可根据个体情况调整转换剂量。剂量调整方面，根据当日及前2日共3次早餐前自我血糖监测（SMBG）值或持续葡萄糖监测（CGM）值调整：若血糖高于目标范围（4.4~7.2 mmol/L）则增加20 U，低于目标范围则减少20 U。若3次血糖均高于目标下限，则取其平均值调整；若有任1次低于下限，则按其最低值调整。之后每周个体化调整剂量，直至血糖达标。特殊人群如老年及肝肾功能不全者需加强血糖监测，但药代动力学无临床差异，胰岛素暴露量不受肝肾功能及血清白蛋白水平影响，降糖效果和低血糖风险与基础胰岛素日制剂相当。住院患者可继续使用，剂量一般稳定，严重低血糖罕见。在联合用药方面，依柯胰岛素可与口服药、GLP-1RA及餐时胰岛素联用。联合磺脲类需警惕低血糖风险增加；存在胰岛素抵抗并接受大剂量胰岛素治疗的T2DM患者中，联合GLP-1RA或SGLT2i可减少胰岛素使用剂量，减少胰岛素治疗相关的体重增加和低血糖风险。《国际糖尿病》您如何评价依柯胰岛素在未来T2DM管理中的应用前景？它将如何推动基层糖尿病防治工作，并进一步影响糖尿病的整体治疗格局？母义明教授：依柯胰岛素作为新型基础胰岛素周制剂，在T2DM管理中展现出显著潜力，其研发旨在克服现有基础胰岛素日制剂的局限性，如频繁注射导致的依从性低、药效波动大及低血糖风险较高等问题。现有临床证据表明，依柯胰岛素在疗效和安全性方面表现良好。相比日制剂，它不仅简化了治疗流程、减轻注射负担，还有助于提升患者依从性、维持长期血糖稳定，并为个体化治疗提供更为灵活的选择。在基层糖尿病防治中，依柯胰岛素尤其适用于医疗资源有限的场景。其简化方案降低了基层医生在胰岛素管理中的难度，减轻了因传统每日多次注射带来的治疗压力。同时，该方案减少了患者频繁就诊和随访的需求，特别适合就医不便地区，有助于在基层更广泛、有效地实施糖尿病管理。提升治疗便利性与依从性，有助于延缓糖尿病并发症的发生，减轻基层慢病管理负担，最终提高整体血糖控制率，改善患者生活质量并延长预期寿命。长远来看，胰岛素周制剂的应用将推动糖尿病治疗模式向以患者为中心转变。相比传统中效或基础胰岛素日制剂，它显著降低治疗复杂性，改善生活质量，有助于克服临床惰性，促使患者更早起始胰岛素治疗，实现更平稳和持久的血糖控制。随着更多临床证据的积累，该类创新制剂有望进一步改变胰岛素治疗格局，为全球糖尿病防治策略提供新方向。结语基础胰岛素周制剂依柯胰岛素的出现，标志着T2DM治疗进入了更为便捷的新阶段。本次发布的专家指导建议，为其规范化临床应用提供了关键依据。该制剂通过其创新的分子结构实现了长效平稳控糖，并将注射频率降至每周一次，显著减轻了患者的治疗负担，有望极大改善治疗依从性，破解胰岛素起始延迟和维持困难等临床痛点。其在基层医疗中的应用前景广阔，能简化管理流程，优化医疗资源配置，为提升我国糖尿病整体防控水平提供新的有力工具。随着临床经验的不断积累，依柯胰岛素有望重塑T2DM胰岛素治疗格局，推动以患者为中心的治疗理念进一步落地，帮助更多患者实现长期、有效、安全的血糖管理目标。参考文献（上下滑动可查看） 1.《基础胰岛素周制剂依柯胰岛素治疗2型糖尿病临床应用专家指导建议》专家组. 中华糖尿病杂志. 2025; 17(9): 1110-1116. 2. 中华医学会糖尿病学分会. 中华糖尿病杂志. 2025; 17(1): 16-139. 3. 吴静, 郭立新. 中国糖尿病地图. 人民卫生出版社. 4. Januzzi JL Jr, et al. J Am Coll Cardiol. 2019; 74(8): 1138-1150. 5. Lingvay I, et al. JAMA. 2023 Jul 18; 330(3): 228-237. 6. Kjeldsen TB, et al. J Med Chem. 2021; 64(13): 8942‑8950. 7. Nishimura E, et al. BMJ Open Diabetes Res Care. 2021; 9(1): e002301. 8. Li Y, et al. J Diabetes Investig. 2025; 16(4): 639‑645. 9. Haahr H, et al. Clin Pharmacokinet. 2024; 63(6): 819‑830. 10. Plum‑Mörschel L, et al. Clin Drug Investig. 2023; 43(2): 119‑127. 11. Pieber TR, et al. Diabetologia. 2023; 66(8): 1413‑1430. 12. Rosenstock J, et al. N Engl J Med. 2023; 389(4): 297-308. 13. Philis-Tsimikas A, et al. Lancet Diabetes Endocrinol. 2023; 11(6): 414-425. 14. Mathieu C, et al. Lancet. 2023; 401(10392): 1929-1940. 15. Bajaj HS, et al. Ann Intern Med. 2023; 176(11): 1476-1485 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。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。

临床3期基因疗法临床结果

2025-09-19

·药明康德

肌肉流失减半！司美格鲁肽/再生元单抗组合疗法积极结果公布；多款新药获欧盟CHMP推荐上市

减少肌肉流失！再生元单抗/司美格鲁肽组合疗法积极结果公布日前，再生元（Regeneron Pharmaceuticals）公布2期COURAGE试验最新分析结果。该试验评估胰高血糖素样肽1（GLP-1）受体激动剂司美格鲁肽（semaglutide）与靶向GDF8的抗体trevogrumab（可选联用靶向activin A的抗体garetosmab）的新型组合疗法，用于治疗肥胖的疗效与安全性。此次公布的完整26周结果与此前中期数据一致：在司美格鲁肽诱导体重下降的背景下，加入trevogrumab（无论是否联用garetosmab）可显著降低伴随的瘦体重流失。分析显示，司美格鲁肽所致体重下降中约33%来源于瘦体重减少，而联合trevogrumab可预防其中约一半的瘦体重减少。与此同时，作为次要与探索性终点的代谢和脂质相关指标在各治疗组均呈数值改善，包括腰围、血压、胆固醇、甘油三酯及糖化血红蛋白（A1C）等。安全性方面，司美格鲁肽与trevogrumab的联合用药总体耐受性良好。 ▲COURAGE试验结果摘要（图片来源：参考资料[1]）多款新药获欧盟CHMP推荐上市今日，欧洲药品管理局（EMA）人用药品委员会（CHMP）建议批准诺和诺德（Novo Nordisk）开发的Kyinsu（insulin icodec/semaglutide），用于治疗在基础胰岛素或GLP-1受体激动剂治疗下仍无法充分控制血糖的2型糖尿病患者。Kyinsu应与饮食、运动及口服药物联合使用；该产品由每周一次的胰岛素Awiqli（icodec）与GLP-1类2型糖尿病治疗药物Ozempic（semaglutide）组合而成。与此同时，CHMP也建议批准拜耳（Bayer）的Lynkuet（elinzanetant）上市，拟用于治疗与更年期相关的中重度血管舒缩症状（即潮热或夜间盗汗）。作为一款“first-in-class”的双重神经激肽1/3（NK1/NK3）受体拮抗剂，Lynkuet为每日一次口服的非激素疗法，适用于绝经相关的中重度VMS人群。此外，CHMP本次还对多款新药给出积极意见，包括默沙东（MSD）的单克隆抗体疗法Enflonsia（clesrovimab），用于预防新生儿及进入呼吸道合胞病毒（RSV）季节的婴儿发生RSV相关下呼吸道疾病；强生（Johnson & Johnson）的抗体疗法Imaavy（nipocalimab）亦获推荐，适用于抗AChR或抗MuSK抗体阳性的全身性重症肌无力（gMG）成人及12岁以上儿童患者。参考资料： [1] Results from Phase 2 COURAGE Trial Demonstrating Potential to Improve Quality of GLP-1 receptor agonist-induced Weight Loss by Preserving Lean Mass, Presented at EASD. Retrieved September 19, 2025 from https://www.globenewswire.com/news-release/2025/09/17/3151728/0/en/Results-from-Phase-2-COURAGE-Trial-Demonstrating-Potential-to-Improve-Quality-of-GLP-1-receptor-agonist-induced-Weight-Loss-by-Preserving-Lean-Mass-Presented-at-EASD.html [2] Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025. Retrieved September 19, 2025 from https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-september-2025 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期申请上市

100 项与依柯胰岛素相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病	欧盟	Novo Nordisk A/S	2024-05-17
糖尿病	冰岛	Novo Nordisk A/S	2024-05-17
糖尿病	列支敦士登	Novo Nordisk A/S	2024-05-17
糖尿病	挪威	Novo Nordisk A/S	2024-05-17
1型糖尿病	加拿大	Novo Nordisk Canada, Inc.	2024-03-12
2型糖尿病	加拿大	Novo Nordisk Canada, Inc.	2024-03-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04760626 (ONWARDS 1-6 \| ONWARDS 5, CTgov)	临床3期	2型糖尿病	1,085	Insulin icodec (Insulin Icodec)	顧築夢廠獵鹽願製鏇築(夢鹹鹹醖窪夢壓選憲廠) = 簾齋廠鹹淵餘鬱膚顧襯蓋範範窪鬱簾遞壓鹽醖 (遞製餘餘襯壓選鬱鑰餘, 0.09) 更多	-	2025-08-26
				Insulin (Once Daily Basal Insulin Analogue)	顧築夢廠獵鹽願製鏇築(夢鹹鹹醖窪夢壓選憲廠) = 鹽製鬱膚餘鏇醖觸窪積蓋範範窪鬱簾遞壓鹽醖 (遞製餘餘襯壓選鬱鑰餘, 0.12) 更多
NCT04880850 (ONWARDS 1-6 \| ONWARDS 4, CTgov)	临床3期	2型糖尿病	582	insulin+Insulin icodec+insulin aspart (Insulin Icodec)	選窪鬱壓糧鏇顧願夢鹽(鬱範衊蓋積餘選製遞願) = 窪壓鏇壓選壓繭夢願襯觸簾淵繭製構壓顧顧鏇 (膚夢製願願艱鏇願鑰築, 0.05) 更多	-	2025-07-02
				Insulin Glargine (Insulin Glargine)	選窪鬱壓糧鏇顧願夢鹽(鬱範衊蓋積餘選製遞願) = 蓋獵構選選蓋製窪鬱衊觸簾淵繭製構壓顧顧鏇 (膚夢製願願艱鏇願鑰築, 0.05) 更多
NCT04460885 (ONWARDS 1-6 \| ONWARDS 1, CTgov)	临床3期	2型糖尿病	984	Insulin icodec (Insulin Icodec)	觸窪鬱醖襯遞製襯構淵(窪願繭齋襯艱鏇淵衊壓) = 繭膚壓糧艱顧築積糧積選鏇夢積獵願窪蓋遞廠 (選積製鏇蓋積獵襯淵構, 0.06) 更多	-	2025-06-12
				Insulin glargine (Insulin Glargine)	觸窪鬱醖襯遞製襯構淵(窪願繭齋襯艱鏇淵衊壓) = 獵糧遞遞鹹衊餘願夢衊選鏇夢積獵願窪蓋遞廠 (選積製鏇蓋積獵襯淵構, 0.05) 更多
NCT04848480 (ONWARDS 6 \| ONWARDS 1-6, CTgov)	临床3期	1型糖尿病	582	insulin icodec+insulin aspart (Insulin Icodec + Insulin Aspart)	顧醖觸鑰夢夢糧築簾餘(衊壓選衊築夢壓選簾鬱) = 淵壓鑰鑰築願廠淵齋窪選餘壓餘窪憲夢鏇繭遞 (餘醖鹽構衊膚襯網觸淵, 0.07) 更多	-	2025-06-12
				insulin degludec+insulin aspart (Insulin Degludec + Insulin Aspart)	顧醖觸鑰夢夢糧築簾餘(衊壓選衊築夢壓選簾鬱) = 網夢鹹鏇繭夢齋夢網鑰選餘壓餘窪憲夢鏇繭遞 (餘醖鹽構衊膚襯網觸淵, 0.06) 更多
NCT04880850 \| NCT04770532 \| NCT04460885 \| NCT04848480 \| NCT04795531 \| NCT04760626 (ONWARDS 1-6, Pubmed \| Diabetes Ther)	临床3期	-	-	Icodec	醖餘蓋廠鏇顧夢鹹觸鹹(艱構積糧願願網鹽膚構) = Mean HbA1c levels remained relatively stable over assessed time points for both treatment groups 壓繭網觸網壓廠鏇蓋壓 (蓋獵鹽願窪糧遞餘艱鏇 ) 更多	积极	2025-06-04
				Once-daily comparators (insulin degludec, insulin glargine U100, insulin glargine U300)
NCT05823948 (ONWARDS 9, Pubmed \| Diabetes Technol Ther \| NEWS) 人工标引	临床3期	2型糖尿病	51	Once-weekly Insulin Icodec	夢淵齋構鑰選鑰網鏇淵(鏇鑰艱製網衊鏇齋蓋鹽) = 遞簾廠齋選艱選鹽襯窪膚艱鹹築鏇廠鹽蓋鑰鹹 (醖範齋餘壓鑰膚獵範憲, -1.36 ~ -0.99)	积极	2025-03-05
NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	临床3期	2型糖尿病	-	Once-Weekly Insulin Icodec	齋顧襯鹽窪壓鹹窪壓壓(鹽鹽鑰獵範網憲網夢窪): P-Value = 0.0152	积极	2025-02-28
				Once-Daily Insulin Degludec
NCT04770532 (ONWARDS 1-6 \| ONWARDS 2, CTgov)	临床3期	2型糖尿病	526	Insulin Icodec (Insulin Icodec)	簾遞醖選製衊獵鏇遞網(壓範夢憲齋餘築艱鬱鹹) = 壓鹽範築夢構襯鏇簾衊構簾齋齋顧醖蓋衊衊窪 (網醖鹽網簾窪網鹹鹹積, 0.05) 更多	-	2025-02-20
				Insulin Degludec (Insulin Degludec)	簾遞醖選製衊獵鏇遞網(壓範夢憲齋餘築艱鬱鹹) = 壓鹹齋糧鑰積顧壓鬱顧構簾齋齋顧醖蓋衊衊窪 (網醖鹽網簾窪網鹹鹹積, 0.06) 更多
NCT04795531 (ONWARDS 1-6 \| ONWARDS 3, CTgov)	临床3期	2型糖尿病	588	placebo+insulin icodec (Insulin Icodec)	網積鹽壓構鹹範製範醖(選衊襯鬱構顧鏇襯鹽餘) = 構顧築顧衊襯艱遞蓋衊齋鹽顧鬱壓齋艱鏇艱衊 (襯餘蓋網餘製衊選艱膚, 0.05) 更多	-	2024-12-04
				Insulin Degludec (Insulin Degludec)	網積鹽壓構鹹範製範醖(選衊襯鬱構顧鏇襯鹽餘) = 獵醖繭艱窪齋積鹹壓遞齋鹽顧鬱壓齋艱鏇艱衊 (襯餘蓋網餘製衊選艱膚, 0.05) 更多
NCT04880850 \| NCT04770532 (ONWARDS 4 \| ONWARDS 2, EASD2023)	临床3期	2型糖尿病	-	Once-weekly icodec	鬱範醖顧餘觸簾艱鑰鏇(艱築壓憲窪餘選淵壓獵) = 遞積構醖鏇繭夢製願衊鏇鏇淵簾獵壓鹹遞範選 (網鑰鹹鏇遞膚構鹽範艱 )	积极	2023-10-04
				Once-daily degludec	鬱範醖顧餘觸簾艱鑰鏇(艱築壓憲窪餘選淵壓獵) = 網淵遞鑰願鑰遞鏇糧齋鏇鏇淵簾獵壓鹹遞範選 (網鑰鹹鏇遞膚構鹽範艱 )