Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study

Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.
A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.
Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.

开始日期2026-03-15

申办/合作机构

中山大学

CTIS2025-521748-39-00

/ Recruiting临床4期IIT

SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy

开始日期2025-11-14

申办/合作机构

Universita Cattolica Del Sacro Cuore

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 项与门冬胰岛素相关的临床结果

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100 项与门冬胰岛素相关的转化医学

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100 项与门冬胰岛素相关的专利（医药）

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1,293

项与门冬胰岛素相关的文献（医药）

2026-04-01·DIABETES OBESITY & METABOLISM

Article

作者: Pitt, Jason P. ; Nicholas, Chloe ; Müller, Alexander ; McCarthy, Olivia M. ; Sourij, Harald ; Moser, Othmar ; Bain, Stephen C. ; Bracken, Richard M.

Abstract:

Aims:

To compare the effects of dose reductions of ultra‐rapid‐acting insulin aspart (URA‐IAsp) and rapid‐acting insulin aspart (IAsp) on blood glucose concentrations during continuous moderate‐intensity exercise in people with type 1 diabetes (T1D).

Materials and Methods:

In this double‐blind, laboratory‐controlled study, 43 adults with T1D completed four experimental visits in a randomised crossover design. Participants injected a 50% or 75% reduced dose of URA‐IAsp or IAsp with a standardised breakfast 60 min prior to 45 min of cycling at ~61% V̇O 2peak . The same insulin type and dose were administered 4 h after the first injection, alongside an identical lunch meal. Venous blood samples were taken at 5‐, 10‐, and 15‐min epochs, for a total of 70 timepoints, throughout the trial day until 4 h after the second injection to determine blood glucose and insulin concentrations. The primary endpoint was the four‐way comparison of blood glucose change from exercise start to end.

Results:

Blood glucose declined during exercise to a similar extent between 50% dose URA‐IAsp (−4.0 ± 2.8 mmol L −1 ) and all other conditions (all p > 0.05), yet fell more in the 50% IAsp dose (−5.1 ± 3.0 mmol L −1 ) compared to the URA‐IAsp (−2.8 ± 3.3 mmol L −1 ) and IAsp (−3.4 ± 3.3 mmol L −1 ) 75% reduced dose conditions (both p < 0.05). Differences in blood insulin concentrations between trials were only resultant of insulin doses and not insulin type from 30 min after the first insulin injection.

Conclusions:

Insulin dose reductions around acute moderate‐intensity exercise yield similar glucose‐lowering effects with URA‐IAsp and IAsp. The extent of dose reductions exerts greater influence on glycaemia than the type of fast‐acting insulin.

2026-03-01·Clinical Drug Investigation

Insulin Aspart-szjj: An Insulin Aspart Biosimilar

Review

作者: McGuigan, Aisling

Insulin aspart-szjj (MERILOG^™) is a biosimilar of the reference rapid-acting insulin analog, insulin aspart, and is approved for the same indication as reference insulin aspart: to improve glycemic control in adult and pediatric patients with diabetes mellitus. The physicochemical characteristics of insulin aspart-szjj were similar to reference insulin aspart, and the pharmacodynamic and pharmacokinetic equivalence of the agents has been shown in patients with type 1 diabetes. Insulin aspart-szjj demonstrated clinical efficacy similar to that of reference insulin aspart in patients with type 1 or type 2 diabetes and was generally well tolerated in this population. The tolerability, safety, and immunogenicity profiles of insulin aspart-szjj were similar to those of reference insulin aspart. The role of insulin aspart in the management of diabetes mellitus is well established, and insulin aspart-szjj provides an effective biosimilar alternative for patients with diabetes mellitus requiring reference insulin aspart.

2026-03-01·Journal of diabetes science and technology

Article

作者: Wilinska, Malgorzata E. ; Thabit, Hood ; Ware, Julia ; Evans, Mark L. ; Hartnell, Sara ; Royston, Chloë ; Lakshman, Rama ; Boughton, Charlotte ; Bally, Lia ; Allen, Janet M. ; Hovorka, Roman ; Nwokolo, Munachiso ; Leelarathna, Lalantha ; Mader, Julia K.

Objective::

The objective was to evaluate the safety and efficacy of ultra–rapid-acting insulin with the Boost and Ease-off features of the Cambridge hybrid closed-loop system.

Methods::

A secondary analysis of Boost and Ease-off from two double-blind, randomized, crossover hybrid closed-loop studies comparing (1) Fiasp to insulin aspart (n = 25), and (2) Lyumjev to insulin lispro (n = 26) was carried out. Mean glucose on initialization of Boost and Ease-off, change in glucose 60 and 120 minutes after initialization, duration and frequency of use, mean glucose, and time in, above, and below target glucose range were calculated for periods of Boost use, Ease-off use, or neither.

Results::

Participants used Boost for longer with Fiasp than insulin aspart (median [interquartile range, IQR] = 75 [53-125] minutes vs 60 [49-75] minutes; P = .01). Mean glucose on Boost initialization with Fiasp was 238 ± 62 mg/dL compared with 218 ± 45 mg/dL with insulin aspart ( P = .08). Fiasp use resulted in a greater glucose reduction 120 minutes after Boost initialization [−59 ± 34 mg/dL vs −43 ± 31 mg/dL; P = .02]. There were no statistically significant differences in sensor glucose endpoints during Boost or Ease-off periods between Fiasp and aspart. There were no statistically significant differences during Boost or Ease-off periods when comparing Lyumjev with insulin lispro. There were no safety issues when using Boost and Ease-off with ultra-rapid insulins.

Conclusions::

The use of Fiasp and Lyumjev during Boost or Ease-off resulted in comparable safety and efficacy to using insulin aspart and lispro.

299

项与门冬胰岛素相关的新闻（医药）

2026-04-15

·雪球

通化东宝，细细看上十遍八遍！

通化东宝→一、买入逻辑：从"胰岛素老炮儿"到"代谢病新贵"的华丽转身要说通化东宝，这名字听着就有一股东北老工业基地的扎实劲儿。但别被这朴实无华的名字骗了——人家可是中国重组人胰岛素的"开山鼻祖"，1998年就搞出了中国第一支重组人胰岛素"甘舒霖"，比很多90后年纪都大。经过二十多年的沉淀，这家公司正在经历一场从"传统仿制药企"向"创新药平台"的蜕变，而2026年正是这场蜕变的关键验收年。1.业绩底已现，集采利空出尽是利好2024年通化东宝经历了上市以来首次亏损，计提了3.18亿元的资产减值，主要是终止了可溶性甘精赖脯双胰岛素项目。但利空出尽后，2025年公司预计净利润超12亿元，实现强势扭亏。这种"V型反转"的走势，像极了被踩到极限的弹簧——压得越狠，弹得越高。集采这把"双刃剑"在东宝手里玩出了花样。2024年全国胰岛素集采续标，公司获得30%以上的二次分配量，协议采购量超4500万支。更重要的是，借助集采的"入场券"，公司四季度加速推进医院准入，三甲医院准入数量显著提升。甘精胰岛素市场份额突破10%，门冬胰岛素系列更是实现"爆发式增长"——新增准入医院2600家，预混型门冬胰岛素新增约6000家。这就像是拿到了全国医院的"VIP通行证"，为后续新产品上市铺好了高速公路。2.产品管线进入"丰收季"，2026-2027年商业化爆发在即通化东宝的研发管线现在就像是一排已经成熟、等待采摘的果树。多款重磅产品均已挺进III期临床阶段，预计2026-2027年将迎来商业化爆发期：-赖脯25R胰岛素：NDA前资料准备阶段，预计2026年12月获批-超速效胰岛素（THDB0206）：国内首个进入临床的四代胰岛素，III期临床已完成出组，预计2027年上市-德谷胰岛素利拉鲁肽注射液：III期临床试验已完成首例受试者给药，进度处于国内第一梯队-司美格鲁肽注射液：III期临床进行中，进度领先于甘李药业这种"梯队式上市"的节奏，完美诠释了什么叫"老品种稳增长、新品种快突破"。就像是一家餐厅，招牌菜（人胰岛素、甘精胰岛素）持续引流，新菜品（四代胰岛素、GLP-1复方制剂）即将上架，客单价和翻台率双升可期。3.成本护城河：30吨级大罐发酵技术的"降维打击"通化东宝手握一项"隐形黑科技"——全球领先的30吨级大罐发酵技术。这套高度自动化的生产线，让公司单位生产成本低于行业平均水平约30%。在集采降价和全球竞争的大环境下，这种极致的成本控制能力就是生存与扩张的"金钟罩"。想象一下，同样的药品，别人卖一支赚5毛，东宝能赚2块，这差距在动辄千万支的销量面前就是碾压级的竞争优势。二、核心"黑科技"：不是花拳绣腿，是真功夫通化东宝的技术储备，可以用"insulin（胰岛素）+incretin（肠促胰素）+innovation（创新）"三个"I"来概括。1.四代胰岛素：超速效的"时间魔法"超速效赖脯胰岛素（THDB0206）是东宝在胰岛素领域的"王炸"产品。作为国内首个进入临床试验阶段的四代胰岛素，它的核心卖点是"更快"——起效更快、达峰更快、代谢更快，完美贴合人体生理需求。对于糖尿病患者来说，这意味着更灵活的用餐时间和更平稳的血糖控制。目前III期临床已完成，预计短期内商业化上市，这将填补国产四代胰岛素的空白。更长远来看，公司还在研发胰岛素周制剂，目前处于临床前研究阶段。一周打一次胰岛素，这简直是糖尿病患者的"终极梦想"，也是全球尚未有产品上市的"无人区"。2.GLP-1领域的"双靶点+口服"组合拳如果说胰岛素是东宝的"基本功"，那GLP-1类药物就是"新派武功"。公司在这一领域的布局堪称"全方位、立体化"：-利拉鲁肽注射液（统博力）：2023年12月获批上市，2025年已在秘鲁获得海外首批准，实现GLP-1产品出海零的突破-司美格鲁肽注射液：引进质肽生物的产品，III期临床进行中，进度国内领先-GLP-1/GIP双靶点受体激动剂（THDBH120）：这是东宝创新管线的"掌上明珠"。通过独特分子设计，有望实现"双周给药+强效降糖减重"效果。Ib期临床数据优异，减重适应症已进入II期临床-口服小分子GLP-1受体激动剂（THDBH110胶囊）：已完成糖尿病适应症I期临床首例受试者入组。口服片剂是GLP-1领域的"圣杯"，一旦成功将彻底改变给药方式这种"注射+口服"、"单靶点+双靶点"、"短效+长效"的组合，让东宝在GLP-1赛道拥有了全维度的竞争力。3.痛风领域的"双靶点"创新除了糖尿病，东宝还在痛风这个"痛起来真要命"的领域布局了XO/URAT1双靶点抑制剂（THDBH151片）。2025年4月完成的IIa期临床试验达到主要终点，这意味着未来可能诞生一款既能降尿酸又能止痛的"全能选手"。依托考昔片的获批上市，也标志着公司业务从糖尿病拓宽至更大的内分泌代谢疾病治疗领域。4.国际化"出海"能力：欧盟GMP认证+海外布局东宝是国内首家通过欧盟cGMP认证的生物制药企业，2024年生产设施再次通过欧洲药品管理局（EMA）检查。门冬胰岛素在印尼、多米尼加获批，甘精胰岛素进入缅甸，人胰岛素系列在乌兹别克斯坦、尼加拉瓜等地上市。更关键的是，公司与科兴制药合作，借助其在新兴市场20多年的渠道积累，已对人口超一亿或GDP排名前三十的新兴市场国家实现全覆盖。这种"生产+注册"双轮驱动的出海模式，让东宝的产品正在从"中国制造"走向"全球供应"。三、巨头合作：不是"抱大腿"，是"强强联合"通化东宝深谙"自主研发+对外合作"的双轮驱动战略，近年来与多家国内外企业达成战略合作，构建起强大的"朋友圈"。1.与惠升生物（四环医药旗下）的"商业化联盟"2026年2月，东宝与惠升生物签署商业化合作协议，获得德谷门冬双胰岛素注射液（惠优加）和德谷胰岛素注射液（惠优达）在中国大陆地区的独家商业化权益。惠优加是首个获批上市的国产德谷门冬双胰岛素注射液生物类似药，而原研厂家诺和诺德的同类产品在大中国区收入已达约43亿元。这次合作就像是拿到了一张"已经验证过的大额支票"——产品已经获批，市场已经验证，东宝只需要发挥销售渠道优势就能变现。更重要的是，这两款产品与东宝现有糖尿病治疗产品形成有效协同，推动基础与餐时一体化复方胰岛素治疗方案的迭代升级。2.与质肽生物的"司美格鲁肽引进"东宝引进了质肽生物的长效GLP-1产品司美格鲁肽注射液，目前正在中国开展III期临床试验。这次引进是对公司GLP-1布局的重要补强，与现有产品形成有效协同，加速构建多层次、多样化的GLP-1产品梯队。3.与科兴制药的"出海搭档"在国际化方面，东宝与科兴制药深度合作，借助后者在新兴市场的渠道优势，利拉鲁肽已在埃及完成GMP现场审计，在哥伦比亚获得GMP证书，在巴西以"零缺陷"通过ANVISA的GMP审计。这种"生产+渠道"的分工合作，让东宝的出海之路走得更稳更快。4.与法国Adocia的技术合作东宝通过与法国Adocia公司的合作，引入第四代胰岛素技术。这种国际合作不仅带来了先进技术，也为公司接轨全球研发前沿打开了窗口。四、近期催化剂：2026年的"引爆点"日历投资讲究"天时地利人和"，通化东宝在2026年可谓"catalyst（催化剂）满满"：1.业绩持续验证（已发生）2025年预计净利润超12亿元，实现扭亏为盈。2026年一季报、半年报将持续验证业绩复苏趋势，彻底打消市场疑虑。2.产品获批上市（高概率事件）-赖脯25R胰岛素：预计2026年底获批-超速效赖脯胰岛素：III期临床已完成，预计2026-2027年上市-依托考昔片：2025年1月已获批，2026年将贡献全年收入3.临床进展里程碑（股价弹性来源）-GLP-1/GIP双靶点激动剂（THDBH120）：减重适应症II期临床数据读出，若数据优异将极大提升估值-司美格鲁肽注射液：III期临床进展，作为"国产版诺和泰"市场关注度极高-德谷胰岛素利拉鲁肽注射液：III期临床推进，国内首仿预期强烈4.国际化突破（估值重构关键）-门冬胰岛素美国FDA申请：2025年7月生物制品许可申请已获FDA受理，预计2027年6月获批。若2026年有实质性进展，将打开欧美高端市场想象空间-人胰岛素欧盟EMA申请：2023年1月已获正式受理，预计2028年获批-利拉鲁肽海外获批：已在秘鲁获批，2026年有望在更多新兴市场获批5.关联公司价值释放（意外之喜）通化安睿特生物（东宝关联公司）自主研发出目前全球唯一获批上市的重组人白蛋白注射液产品，生产基地投资近30亿元，是全球最大的白蛋白生物制药基地。2026年若科创板IPO取得实质性进展，其"全球首创"产品的巨大价值获得资本市场认可，可以极大缓解大股东质押压力，间接利好东宝估值。6.替利珠单抗的"间接助攻"2025年9月，全球首个用于延缓1型糖尿病进展的创新药替利珠单抗在华获批。这款药能将患者进展至需终身胰岛素治疗的时间延缓近3年，但患者最终仍需长期胰岛素治疗。东宝作为国产胰岛素龙头，全系列产品以A类中选集采，将间接受益于早筛市场和胰岛素需求的持续释放。五、总结：时来天地皆同力？通化东宝2026年的投资逻辑，可以用一句话概括："业绩底+产品爆发+国际化破局+创新药兑现"的四重奏。公司不再是那个只靠人胰岛素打天下的"单脚跳"选手，而是形成了"胰岛素基本盘稳如泰山、GLP-1创新药蓄势待发、痛风等代谢病领域多点开花、国际化布局渐入佳境"的"多引擎驱动"格局。30吨级大罐发酵技术的成本护城河、欧盟GMP认证的质量背书、与惠升生物和科兴制药等巨头的战略合作，构成了难以复制的竞争壁垒。当然，投资永远有风险。创新药临床失败的可能、胰岛素集采续约的价格压力、国际化进程的不确定性，都是需要警惕的"暗礁"。但站在2026年的时点，通化东宝似乎正处于"风物长宜放眼量"的拐点——利空出尽，利好累积，只待"时来天地皆同力"的那一刻。毕竟，在糖尿病这个全球5.89亿患者的超级赛道，能够同时玩转"传统胰岛素升级+GLP-1创新药突破+国际化出海"的中国玩家，屈指可数。通化东宝，或许正在从"中国的诺和诺德"向"世界的东宝"蜕变。老师们阅读后对通化东宝还有哪些补充意见？欢迎友善评论及指正！本文摘自网络公开信息，不作为买卖依据❗

2026-04-13

·国际糖尿病idiabetes

胰岛素：百年创新与超越——从拯救生命到重塑健康未来

点击“蓝字”关注我们编者按：胰岛素的发现，堪称二十世纪医学史上重大的里程碑——它让糖尿病从无药可救的绝症，转变为可被长期管理的慢性疾病。过去一个世纪，伴随着对糖尿病认知的深化和生物制药技术的迭代，胰岛素经历了从动物粗提物，到精密模拟生理分泌的类似物，乃至迈向具备“智能响应”功能的创新制剂的历史性演进。本文将系统梳理胰岛素百年发展的关键节点，分析当前治疗路径，并前瞻未来方向，旨在为关注该领域的医患群体、产业界及公共卫生决策者，提供一份系统而前瞻的参考。百年演进：从奇迹发现到科学基石 1 漫长探索：从模糊认知到靶点锁定在胰岛素诞生前，人类对糖尿病的认知长期停滞于表象观察。古埃及已有关于多尿症状的记载，古希腊文献中亦可见类似描述，但这些观察均未能触及疾病的本质[1,2]。直至19世纪，德国学者Paul Langerhans在胰腺中发现独特细胞团簇（后称“胰岛”），首次为糖尿病研究锚定了解剖学靶点[3]。随后的动物实验进一步证实：胰腺分泌着维系血糖平衡的关键物质，而其缺乏直接导致糖尿病[4]。至此，科学探索的焦点凝聚于如何提取这一神秘物质。 1921年，班廷成功从狗胰腺中提取出具有生物活性的胰岛素物质[5]。其后，生物化学家James Collip对对提取物进行精制纯化，使其得以安全用于人体[6]。1922年，该胰岛素被应用于一名14岁的1型糖尿病患者Leonard Thompson，其危重的高血糖与酮症得到奇迹般逆转——这标志着现代糖尿病治疗纪元的正式开启。 2 超越治疗：胰岛素带来的多重科学革命从动物胰腺提取物起步，胰岛素经历了百年演进，历经基因工程合成的人胰岛素，逐步发展出速效、长效、预混及超长效类似物，并进一步实现了每周一次给药的基础胰岛素周制剂，每一步都标志着药学技术与治疗理念的跃升。胰岛素演进从根本上重塑了代谢领域。它不仅精准揭示了胰岛素绝对或相对缺乏是糖尿病病理生理的核心[7]，还通过阐明其对糖、脂肪、蛋白质代谢的调节机制（图1），奠定了现代代谢研究的基石。图1. 胰岛素与糖、蛋白、脂肪代谢同时，一系列大型临床研究对胰岛素治疗的探索，促进了糖尿病管理理念的持续发展（图2）。例如，DCCT/EDIC研究证实，早期强化胰岛素治疗可带来长期获益[8]。UKPDS研究证实了新诊断2型糖尿病（T2DM）患者早期强化治疗可带来长期并发症获益[9]。这些研究开创了以长期硬终点为导向的循证实践范式，引领现代医学进入以高质量证据为决策核心的循证时代[10]。图2. 胰岛素治疗相关的循证研究胰岛素研究对现代科学的贡献不仅限于代谢领域，更延伸至蛋白质科学、生物技术、化学技术等众多科学领域。其中，在蛋白质科学领域，胰岛素是全球首个人工合成的蛋白质。其氨基酸序列的测定和三维结构的解析为蛋白质折叠与功能研究奠定了基础。同时，胰岛素生物合成途径的阐明及其高灵敏、特异性测量方法的建立，推动了蛋白质研究的整体方法论进步[11]。在生物技术领域，胰岛素首次将重组DNA技术应用于大规模生产，其后进一步使用酵母系统进行生产，建立了安全、可扩展的工业化生产体系。这一技术不仅开创了生物制药的新纪元，也为后续各类重组蛋白药物（如生长激素、干扰素、抗体类药物）的研发与生产铺平了道路[12]。精准调控与策略升级：胰岛素治疗的现代化路径彭永德教授曾在学术会议上提到，现代胰岛素治疗的核心目标是精准模拟人体生理性胰岛素分泌模式。在生理状态下，胰岛素分泌呈现两种基本模式：基础分泌以持续、低速率的胰岛素释放，抑制肝脏葡萄糖输出，维持空腹血糖稳定；餐时脉冲分泌则在进食后迅速大量释放胰岛素，促进葡萄糖利用与储存，从而有效控制餐后血糖升高（图3）。图3. 生理胰岛素分泌模式为了模拟这一理想状态，胰岛素研发长期围绕“基础-餐时胰岛素”方案不断演进，形成了一套多维度、系统化的现代治疗策略。 1 基础胰岛素的持续革新基础胰岛素的发展史，是一部向更持久、更平稳、更贴近生理方向演进的技术革新史。早期使用的中效胰岛素（如NPH）存在明显的药效峰值，易引发夜间低血糖风险。随着分子修饰技术的突破，第一代长效类似物（如地特胰岛素）实现了无峰值的平稳释放，显著降低了低血糖发生率。新一代超长效类似物（如德谷胰岛素）通过结构优化与制剂创新，进一步将作用时间延长至30~42小时，为血糖控制提供了更平稳、更持久的解决方案[13]。最具里程碑意义的突破是基础胰岛素周制剂——依柯胰岛素的问世。其通过脂肪酸酰化技术显著延长半衰期达196小时，实现了每周一次给药的革命性跨越（图4）。这一突破将患者全年的基础胰岛素注射次数从365次减少至约52次，不仅极大减轻治疗负担、提高依从性，也为糖尿病长期管理提供了更人性化、更贴近生理节律的治疗选择[14,15]。图4. 依柯胰岛素的分子结构 2 餐时胰岛素的快速匹配餐时胰岛素的进化方向是不断缩短起效时间，以更好地匹配餐后快速上升的血糖水平。传统的短效人胰岛素需在餐前30分钟注射，而新一代速效胰岛素类似物，如门冬胰岛素，将起效时间缩短至10~15分钟，可实现餐前即刻甚至餐后立即注射。这不仅为患者提供了更灵活的生活方式，也有助于减少迟发性低血糖的发生风险。 3 复合制剂的简化策略为在疗效与便捷性之间取得平衡，预混胰岛素和双胰岛素类似物应运而生。这类制剂通过两种方式简化治疗方案：一是将基础与餐时胰岛素按固定比例预先混合（如预混门冬胰岛素30）；二是利用创新技术使基础与餐时成分在注射后独立发挥各自作用（如德谷门冬双胰岛素）。这两种设计均在减少每日注射次数的同时，实现对空腹及餐后血糖的双重控制，特别适用于仍保留部分胰岛素分泌功能的T2DM患者。 4 联合治疗的协同强化针对T2DM复杂的病理生理机制，胰岛素联合其他作用机制的药物已成为核心优化策略[16]。例如，胰岛素和胰高糖素样肽-1受体激动剂（GLP-1RA）的联合应用：胰岛素直接补充内源性胰岛素分泌不足，降低空腹血糖；而GLP-1RA则以葡萄糖浓度依赖性方式促进胰岛素分泌、抑制胰高血糖素释放、延缓胃排空，从而在控制餐后血糖、减轻体重及心血管保护方面发挥协同作用[17]。 5 技术赋能的个体化管理现代监测与管理技术提高了胰岛素治疗的精细化管理。持续葡萄糖监测（CGM）通过提供实时、全面的葡萄糖图谱，推动治疗从经验推断转向数据驱动。胰岛素泵与CGM联动的混合闭环系统，能够根据血糖读数自动调节基础胰岛素输注率，已初步实现“人工胰腺”功能[18]。同时，数字化管理平台与应用程序通过整合胰岛素剂量、血糖、饮食、运动等多维数据，构建起支持远程指导、医患协同与自我管理的智能生态系统[19]，进一步推动糖尿病管理的现代化与智能化发展。综上所述，现代胰岛素治疗已超越早期简单的替代补充理念，发展成为一套集生理模拟精准化、制剂方案个性化、治疗机制协同化、管理手段智能化于一体的高度整合模式。这一演进不仅显著提升血糖控制的安全性、有效性及患者依从性，更从根本上改善糖尿病患者的生活质量与远期预后，同时为迈向更理想、更智慧的糖尿病管理新时代奠定了坚实基础。未来展望：突破瓶颈，迈向智能与治愈新纪元尽管已取得显著成就，当前胰岛素治疗仍面临几项关键挑战：进一步降低低血糖风险、提升患者生活质量、更精准地模拟生理性胰岛素分泌模式以及提高治疗可及性与经济性。目前的研究与开发正围绕这些核心问题持续推进，旨在为糖尿病患者带来更安全、更便捷、更符合生理且更具成本效益的治疗方案。 1 联合治疗：从协同增效到病理根源干预目前，胰岛素周制剂与GLP-1RA周制剂的联合制剂正处于研发阶段。此类联合制剂通过机制互补，协同调控血糖与体重（图5），有望实现“双周一次”或“每月一次”的超长效给药方案，从而显著简化治疗流程、减轻患者负担，并进一步提升治疗依从性。图5. 基础胰岛素与GLP-1RA的协同作用更前沿的研究正探索以胰岛素为核心，联合作用于胰岛素抵抗、慢性炎症、代谢相关脂肪性肝病、β细胞功能保护及凋亡抑制等多重病理生理环节的创新治疗方案。此类多靶点、多维度的联合策略，旨在从疾病根源进行干预，不仅追求血糖稳定控制，更致力于实现机体长期代谢稳态的重建，从而为T2DM功能性逆转提供潜在可能[20]。 2 更便捷的给药：口服胰岛素口服胰岛素因其无创便捷、可模拟生理性门静脉输注途径等优势，长期以来被视为糖尿病药物治疗的理想选择，但其发展面临多重生物学障碍：胃内酸性环境易导致胰岛素变性失活，肠道中丰富的蛋白酶可快速降解其肽链结构，而肠上皮紧密连接及胰岛素分子本身的亲水性也严重限制了其跨膜吸收，导致口服生物利用度普遍低于1%[21]。为克服这些屏障，研究已取得一系列进展：通过脂质体、纳米粒等包埋技术及肠溶包衣策略保护胰岛素免受胃肠道环境破坏；利用渗透促进剂和细胞穿透肽增强其在肠道黏膜的透过性；并开发肠道微针胶囊、仿生载体系统等新型递送技术以提升靶向吸收效率[22]。尽管目前尚无口服胰岛素产品成功实现大规模商业化应用，但随着制剂工程与纳米递送技术的持续进步，这一更具生理贴合性、用药更便利的治疗方案正逐步从科学理想迈向临床现实。 3 更智能的胰岛素：葡萄糖敏感性胰岛素葡萄糖敏感性胰岛素的核心机制是在胰岛素分子结构中引入可感应葡萄糖浓度的“分子开关”。例如，候选分子NNC2215在血糖升高时，其分子构象发生改变，增强与胰岛素受体的结合能力，从而促进降糖作用；当血糖降低时，分子开关“关闭”，减弱其生物活性，进而显著降低低血糖风险[23]。这类智能胰岛素分子能够更贴近生理性胰岛素分泌的动态调节模式，有望实现更安全、更自主的血糖管理，代表了胰岛素疗法向仿生智能化方向演进的重要趋势。 4 更整合的系统：数字化与闭环生态系统未来的糖尿病管理将是一个高度整合的数字化生态系统。这不仅仅是设备的连接，更是数据、算法和服务的深度融合[24]。高级混合闭环及全闭环系统将搭载更智能的算法，实现餐食、运动等日常代谢扰动的自动识别与响应，推动血糖调节走向全自动化。人工智能与大数据技术将应用于血糖趋势预测、个性化胰岛素剂量调整与生活方式指导，并可提前预警高低血糖风险。基于云平台的虚拟照护与远程医疗系统，能够实现患者实时数据与医疗团队的无缝共享，打破地理限制，支持远程监测、即时干预与个体化指导，从而系统性提升糖尿病管理的效率、质量与可及性。创新·超越·未来：胰岛素的百年征程胰岛素的百年历程，是一部从绝望中诞生希望、在探索中实现超越、于创新中定义未来的医学史诗。它从一个挽救生命的简单提取物，成长为驱动蛋白质科学和生物技术革命的引擎，持续推动糖尿病管理理念的每一次突破。今天，周制剂重塑了治疗便捷性的标准，CGM与智能算法正将管理推向精准化。展望未来，葡萄糖敏感性胰岛素、口服制剂和智能化闭环系统，将共同开启一个更安全、更自主、更智能的糖尿病管理新时代。站在新百年的起点，胰岛素的故事仍在继续——它以持续创新的生命力，为数亿患者照亮通往更健康、更自主生活的道路，生动诠释着医学守护人类健康的永恒使命。参考文献（上下滑动可查看） 1. Mohajan, Devajit (2023): Historical View of Diabetics Mellitus: From Ancient Egyptian Polyuria to Discovery of Insulin. Published in: Studies in Social Science & Humanities , Vol. 2, No. 7 (12 August 2023): pp. 26-34. 2. Kurtzhals P, Gough S. Diabet Med. 2021; 38(12): e14623. 3. Langerhans P. Beiträge zur mikroskopischen Anatomie der Bauchspeicheldrüse. Inaugural-Dissertation, Berlin, 1869. 4. von Mering J, Minkowski O. Diabetes mellitus nach Pankreasexstirpation. Arch Exp Pathol Pharmakol. 1890; 26: 371-387. 5. Banting FG, Best CH. The internal secretion of the pancreas. J Lab Clin Med. 1922; 7: 251-266. 6. Banting FG, Best CH, Collip JB, et al. Pancreatic extracts in the treatment of diabetes mellitus. Can Med Assoc J 1922;12:141-146. 7. Sanger F. The arrangement of amino acids in proteins. Adv Protein Chem 1952;7:1-67. 8. The Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986. 9. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-853. 10. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Intensive diabetes treatment and cardiovascular outcomes in type 1 diabetes: the DCCT/EDIC study 30-year follow-up. Lancet Diabetes Endocrinol 2016;4:561-569. 11. Goeddel DV, Kleid DG, Bolivar F, et al. Expression in Escherichia coli of chemically synthesized genes for human insulin. Proc Natl Acad Sci U S A 1979;76:106-110. 12. Chance RE, Frank BH. Research, development, production, and safety of biosynthetic human insulin. Diabetes Care 1993;16(Suppl 3):133-142. 13. Heise T, Nosek L, Bøttcher SG, et al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect. Diabetes Obes Metab 2012;14:944-950. 14. Zinman B, Philis-Tsimikas A, Cariou B, et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 2012;35:2464-2471. 15. Heise T, Chien J, Beals JM, et al. Pharmacokinetic and pharmacodynamic properties of insulin icodec compared with insulin glargine U100 and degludec in people with type 2 diabetes. Diabetes Care 2021;44:1017-1024. 16. DeFronzo RA, Buse JB, Kim T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet 2015;385:2057-2066. 17. Gough SCL, Bode B, Woo V, et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol 2014;2:885-893. 18. 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;42:1593-1603. 19. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med 2019;381:1707-1717. 20. Bailey CJ, Tahrani AA, Barnett AH. Future glucose-lowering drugs for type 2 diabetes. Lancet Diabetes Endocrinol 2016;4:350-359. 21. Heinemann L, Jacques Y. Oral insulin and buccal insulin: a critical reappraisal. J Diabetes Sci Technol 2009;3:568-584. 22. Veiseh O, Tang BC, Whitehead KA, et al. Managing diabetes with nanomedicine: challenges and opportunities. Nat Rev Drug Discov 2015;14:45-57. 23. Chuang VT, Kragh-Hansen U, Otagiri M. Pharmaceutical strategies utilizing recombinant human serum albumin. Pharm Res 2002;19:569-577. 24. Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 2016;316:1407-1408. 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。

2026-04-09

·PRNewswire

Gan & Lee Pharmaceuticals Signs Exclusive License Agreement with JW Pharmaceutical, the Leading South Korean Pharma, to Advance the Global Commercialization of the Innovative GLP-1 Receptor Agonist Bofanglutide

BEIJING and BRIDGEWATER, N.J., April 9, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", SSE: 603087) announced the signing of an exclusive licensing agreement with JW Pharmaceutical, a leading pharmaceutical company in South Korea. Under the agreement, the two parties will collaborate on the clinical development, regulatory filing, and commercialization in South Korea of Bofanglutide Injection, a bi-weekly (once every two weeks) Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) independently discovered and developed by Gan & Lee. Continue Reading Strategic Alliance: By Leveraging JW's Strengths in R&D and Commercialization in South Korea, Gan & Lee Will Establish a Strong Commercial Footprint in South Korea's High-Potential Metabolic Disease Market Under the terms of the agreement, JW Pharmaceutical will be granted the exclusive rights to develop and commercialize Bofanglutide Injection in South Korea. Gan & Lee Pharmaceuticals will receive a one-time, non-refundable upfront payment of USD 5 million. Additionally, Gan & Lee is eligible to receive milestone payments totaling USD 76.1 million, contingent upon research and development progress, regulatory approvals, and commercialization achievements. Following the product's commercial launch, Gan & Lee will also receive tiered royalties based on net sales. The total potential transaction value reaches up to USD 81.1 million (excluding royalties). This collaboration marks the third overseas out-licensing deal for Gan & Lee's Bofanglutide Injection, following previous partnerships in Latin America and India. According to data from Grand View Research, the GLP-1RA market in the Asia-Pacific region reached USD 5.47 billion in 2025 and is projected to grow to USD 16.95 billion by 2033, representing a compound annual growth rate (CAGR) of 14% [1], making it one of the fastest-growing regions globally. Currently, the treatment penetration rate of GLP-1 drugs remains extremely low, indicating massive growth potential. As a mature market in the Asia-Pacific region, South Korea's GLP-1RA market size reached USD 526 million in 2025 and is expected to increase to USD 1.6 billion by 2033 [2]. With its high acceptance of innovative drugs and strong patient purchasing power, the South Korean market has become a strategic foothold for multinational pharmaceutical companies entering East Asia. This collaboration marks another key step in the rapid global expansion of Gan & Lee's differentiated bi–weekly GLP–1RA, Bofanglutide. Steady Progress in Global Phase III Clinical Trials; Bi-weekly Dosing Regimen Significantly Enhances Patient Compliance Currently, as the world's first bi-weekly GLP-1RA to enter Phase III clinical research, Bofanglutide has advanced into the critical Phase III stage of its global development for three proposed indications: obesity/overweight, type 2 diabetes mellitus (T2DM), and obstructive sleep apnea (OSA). Existing clinical data demonstrate that Bofanglutide can effectively reduce body weight and blood glucose levels while comprehensively improving other metabolic parameters, yielding overall metabolic benefits. Its safety and tolerability profiles are consistent with other GLP-1RA class therapies. The bi-weekly dosing regimen further reduces the annual number of injections by 50% compared to mainstream once-weekly GLP-1RAs. This is anticipated to substantially boost patient adherence, offering a more convenient treatment option for the long-term, effective management of metabolic diseases. As the global burden of metabolic diseases continues to rise, GLP-1 therapies are encountering tremendous market opportunities. South Korea, as one of the world's key pharmaceutical markets, exhibits a robust demand for innovative diabetes and weight-loss therapies. This collaboration will effectively address the clinical and commercial needs of the South Korean market for highly efficacious and convenient treatment regimens. "This partnership with JW Pharmaceutical marks another pivotal step in the globalization strategy for Bofanglutide," stated Dr. Zhi Li, Chief Business Officer of Gan & Lee Pharmaceuticals. "GLP-1 therapies are reshaping the global treatment landscape for metabolic diseases. The convenience of Bofanglutide's bi-weekly dosing and its compelling clinical benefits will help address the unmet medical needs of South Korean patients. With over 80 years of experience, JW brings deep development and commercial expertise in metabolic diseases—a key factor in our decision to partner with JW." Young-sub Shin, CEO of JW Pharmaceutical, commented: "This agreement represents a significant milestone in expanding our product portfolio within the rapidly growing therapeutic area of metabolic diseases, particularly diabetes and obesity. JW Pharmaceutical will leverage its established expertise in clinical development and regulatory execution, remaining committed to advancing the development and commercialization of Gan & Lee's Bofanglutide in South Korea, thereby bringing innovative treatment options to South Korean patients." About Bofanglutide Bofanglutide Injection (GZR18), independently developed by Gan & Lee Pharmaceuticals, is a bi-weekly administered GLP-1RA designed for the treatment of obesity/overweight, type 2 diabetes mellitus (T2DM), and other metabolic diseases. Clinical research data indicates that Bofanglutide can effectively reduce body weight and lower blood glucose levels, while comprehensively improving other metabolic parameters. With safety and tolerability profiles consistent with the GLP-1RA class of drugs, it is poised to potentially become the world's first commercially available bi-weekly GLP-1RA. Currently, the global development of Bofanglutide Injection has entered the Phase III clinical research stage. About JW Pharmaceutical Founded in 1945, JW Pharmaceutical Corporation has been a leader in Korea's therapeutic pharmaceutical market, guided by its founding principles of respect for life and a spirit of challenge. With a robust portfolio of original medicines, JW Pharmaceutical has focused on innovative drug discovery and development since the establishment of its Central Research Institute in 1983 and the C&C Research Laboratories in 1992. Through advanced research technologies, including its AI-based drug discovery and development platform, JWave, the company has built a strong pipeline in areas such as oncology, immunology, and regenerative medicine. JW Pharmaceutical also actively pursues diverse research initiatives aligned with global trends through open innovation. JW Pharmaceutical Corporation is listed on the Korea Exchange under the ticker "001060." References: Grand View Research. (2026). Asia Pacific GLP-1 Receptor Agonist Market Size & Outlook, 2033 (Horizon Databook), Grand View Research. (2026). South Korea GLP-1 Receptor Agonist Market Size & Outlook, 2033, Gan & Lee Pharmaceuticals Officially Initiates GRADUAL-3, China's First Phase III Clinical Trial for Weight Management with a Once-Monthly GLP-1RA. [Press Release], From "Follower" to "Leader": Domestic Bi-weekly Bofanglutide Debuts at ADA, Ushering in "China Time" for Diabetes Treatment. [Press Release], Gan & Lee Pharmaceuticals' Bofanglutide (GZR18) Injection Approved for Clinical Trial of New Indication: Moderate to Severe Obstructive Sleep Apnea in Obese Adult Patients. [Press Release], Gan & Lee Pharmaceuticals Enters into an Exclusive Commercial Agreement with Renowned Latin American Pharmaceutical Company PC for Bofanglutide. [Press Release], Gan & Lee Pharmaceuticals Enters into a Partnership with Leading Indian Pharmaceutical Company Lupin. [Press Release], About Gan & Lee Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline. Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin®; EU brand name Ondibta®), insulin lispro injection (Prandilin®; EU brand name: Bysumlog®), insulin aspart injection (Rapilin®; EU brand name: Dazparda®), premixed insulin lispro protamine suspension injection (25R) (Prandilin®25), and insulin aspart 30 injection (Rapilin®30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin®30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins. In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion. Insulin glargine injection has received marketing authorization from the European Commission (EC), while for insulin lispro injection and insulin aspart injection, it has received the positive opinion from CHMP of EMA. Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases. Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas. SOURCE Gan & Lee Pharmaceuticals 21% more press release views with Request a Demo

引进/卖出临床3期上市批准

100 项与门冬胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04475	门冬胰岛素	A10AD05 A10AB05	DB01306

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	日本	Novo Nordisk A/S	2019-09-20
糖尿病	欧盟	Novo Nordisk A/S	1999-09-07
糖尿病	冰岛	Novo Nordisk A/S	1999-09-07
糖尿病	列支敦士登	Novo Nordisk A/S	1999-09-07
糖尿病	挪威	Novo Nordisk A/S	1999-09-07

未上市

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适应症	最高研发状态	国家/地区	公司	日期
肥胖	临床3期	西班牙	Novo Nordisk A/S	2005-04-01
急性淋巴细胞白血病	临床3期	美国	Novo Nordisk A/S	2004-04-01
淋巴母细胞淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
伯基特淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
低血糖	临床3期	澳大利亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	克罗地亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	丹麦	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	意大利	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	南非	Novo Nordisk A/S	2001-09-01

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临床结果

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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


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)	構鑰壓積醖積顧鑰觸願(鏇醖淵憲築鏇夢膚膚衊) = 觸顧壓艱構壓簾壓艱糧齋糧範齋鬱顧製艱鑰築 (膚糧積範製鹹顧遞窪壓, 0.07) 更多	-	2025-06-12
				insulin degludec+insulin aspart (Insulin Degludec + Insulin Aspart)	構鑰壓積醖積顧鑰觸願(鏇醖淵憲築鏇夢膚膚衊) = 鑰憲網網襯鹹簾襯獵製齋糧範齋鬱顧製艱鑰築 (膚糧積範製鹹顧遞窪壓, 0.06) 更多
NCT03659799 (Pubmed)	临床4期	1型糖尿病	40	insulin type (ultra-rapid vs rapid insulin) (Rapid aspart)	蓋窪願遞鑰簾簾膚繭襯(衊衊遞繭鑰網積鑰窪遞) = 積窪鏇積糧繭鏇廠鬱淵憲齋網憲鬱遞淵窪膚鏇 (網夢齋獵簾築鹹遞願願 )	积极	2024-07-29
				insulin type (ultra-rapid vs rapid insulin) (Exercise at 60 min post meal)	製餘鬱構網遞願鹹糧齋(膚蓋餘齋積選積鑰網糧) = 醖艱蓋壓蓋網獵鏇醖觸繭積築衊鹹鹹餘憲範夢 (選獵獵壓淵淵獵夢鏇願, 1.2 ~ 100%)
NCT04538352 (TRANSITION-T2D, CTgov)	临床4期	2型糖尿病	60	Semaglutide+Insulin Degludec+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	選繭鏇顧憲淵壓製夢範(鏇淵顧糧製壓膚積齋蓋) = 夢築鹽襯鬱簾製積廠衊衊餘鹽鏇獵齋製廠蓋簾 (衊淵鏇蓋鑰艱鑰選繭鹽, 構範鑰膚鏇願夢窪鬱蓋 ~ 艱積壓糧繭壓餘窪遞窪) 更多	-	2024-07-29
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	選繭鏇顧憲淵壓製夢範(鏇淵顧糧製壓膚積齋蓋) = 壓齋鹹壓積積襯廠構繭衊餘鹽鏇獵齋製廠蓋簾 (衊淵鏇蓋鑰艱鑰選繭鹽, 製鹹積窪願遞築鹹獵鑰 ~ 願積顧網網艱獵醖鑰衊) 更多
NCT04588259 (CTgov)	临床3期	1型糖尿病 \| 2型糖尿病	331	Insulin Degludec+Faster aspart	餘繭鑰淵繭遞網製選醖(淵艱構構夢壓簾築夢憲) = 築憲鏇蓋糧壓糧願襯鹹齋鹽選觸鬱膚觸觸鹹選 (淵獵願繭觸選鏇鏇網壓, 0.63) 更多	-	2024-03-20
NCT04460326 (In-FI, CTgov)	临床3期	2型糖尿病	137	Insulin glargine+NovoLog (Group 1 Insulin Glargine and Novolog)	廠積製顧顧憲簾鏇獵襯(製鏇糧襯襯艱獵製鑰膚) = 淵艱壓遞選衊繭簾製淵壓衊壓鬱廠繭鏇淵鑰艱 (積鹽廠網壓夢齋製鬱鏇, 29.78) 更多	-	2024-03-19
				Insulin glargine+Insulin Fiasp (Group 2 Insulin Glargine and Fiasp)	廠積製顧顧憲簾鏇獵襯(製鏇糧襯襯艱獵製鑰膚) = 範範夢鬱繭觸廠觸鑰艱壓衊壓鬱廠繭鏇淵鑰艱 (積鹽廠網壓夢齋製鬱鏇, 32.63) 更多
NCT03770767 (CopenFast, Pubmed \| Lancet Diabetes Endocrinol)	临床3期	妊娠期糖尿病	216	Faster-acting insulin aspart	簾襯鹽夢齋膚襯選構鹽(觸襯鹹衊製構膚糧築製) = 鬱壓鬱鹽願蓋積遞糧構簾窪繭艱醖襯簾鹽壓構 (範淵遞獵淵築艱廠鬱夢, 6)	积极	2023-11-01
				Insulin aspart	簾襯鹽夢齋膚襯選構鹽(觸襯鹹衊製構膚糧築製) = 範醖選築鑰廠糧構衊鏇簾窪繭艱醖襯簾鹽壓構 (範淵遞獵淵築艱廠鬱夢, 7)
NCT03770767 (Copenfast, EASD2023)	临床3期	1型糖尿病 \| 2型糖尿病	216	Faster-acting insulin aspart	夢憲範鬱積廠壓獵鹹網(窪製範窪範餘簾廠構網) = 鏇窪蓋積遞觸艱艱齋餘顧積製製餘顧鬱廠製壓 (膚鑰鏇衊觸網艱廠範構, 38 ~ 46) 更多	积极	2023-10-05
				Insulin aspart	夢憲範鬱積廠壓獵鹹網(窪製範窪範餘簾廠構網) = 繭廠積蓋簾糧憲襯構淵顧積製製餘顧鬱廠製壓 (膚鑰鏇衊觸網艱廠範構, 39 ~ 46) 更多
NCT00913497 (CTgov)	临床4期	1型糖尿病	16	insulin glulisine (Insulin Glulisine)	齋鹹壓憲淵積觸網範壓(襯繭壓鑰艱構衊鬱願繭) = 觸醖積築壓獵繭簾繭簾夢鏇夢顧憲艱鬱醖襯淵 (築獵範鹹遞選淵壓觸選, 15.7) 更多	-	2023-09-18
				insulin aspart (Insulin Aspart)	齋鹹壓憲淵積觸網範壓(襯繭壓鑰艱構衊鬱願繭) = 襯獵鏇獵蓋衊蓋選築範夢鏇夢顧憲艱鬱醖襯淵 (築獵範鹹遞選淵壓觸選, 14.7) 更多
NCT04853030 (Pubmed \| Diabetes Technol Ther)	N/A	1型糖尿病	30	Faster Insulin Aspart	簾襯醖簾顧糧壓憲觸壓(繭憲觸壓積衊鑰鏇簾鹹) = 壓簾遞襯淵糧壓簾鑰艱製鹹壓顧壓築餘鑰獵艱 (襯顧鏇壓蓋鹹艱製築艱 ) 更多	不佳	2023-09-01
				Standard Insulin Aspart	簾襯醖簾顧糧壓憲觸壓(繭憲觸壓積衊鑰鏇簾鹹) = 艱糧繭醖網鹽選顧積糧製鹹壓顧壓築餘鑰獵艱 (襯顧鏇壓蓋鹹艱製築艱 ) 更多
NCT03895515 (Pubmed \| Diabetes Ther)	N/A	1型糖尿病	178	Fast-Acting Insulin Aspart	淵鹹積艱網窪齋壓築積(壓網醖蓋艱憲鑰選鬱壓) = 顧繭觸鏇繭糧觸鬱窪簾廠膚醖顧遞網簾鏇顧繭 (襯鹽鑰構廠構糧糧網選 )	积极	2023-07-14