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

CTRI/2026/01/100469

/ Not yet recruitingN/A

An open label, balanced, randomized, two-treatment, twosequence,two-period, single-dose, crossover pharmacokinetic andpharmacodynamic bioequivalence study of Insulin DegludecInjection 100 Units/mL Manufactured by Jilin HuishengBiopharmaceutical Co., Ltd. for Lupin Ltd, India comparing withInsulin Degludec Injection (TRESIBA ) of Novo Nordisk inhealthy, adult, human participants using Euglycaemic clamptechnique under fasting conditions. - NIL

开始日期2026-01-22

申办/合作机构

Lupin Ltd.

CTIS2025-521748-39-00

/ Completed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

100 项与德谷胰岛素相关的临床结果

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100 项与德谷胰岛素相关的转化医学

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100 项与德谷胰岛素相关的专利（医药）

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912

项与德谷胰岛素相关的文献（医药）

2027-03-01·Value in Health Regional Issues

Evaluation of the Clinical Effectiveness and Cost-Effectiveness of Tirzepatide for Type 2 Diabetes in Canada Using Bayesian Transportability Analysis

Article

作者: Wilbur, Jayson D ; Metcalfe, Rebecca K ; Abdul-Karim, Rasha ; Park, Jay J H ; Yan, Yichen ; Alam, Shomoita ; Dyrkton, Nathaniel

OBJECTIVES:

To estimate the clinical and cost-effectiveness of tirzepatide in Canada using transportability analysis.

METHODS:

We applied Bayesian transportability analysis to patient-level data from the SURPASS-3 trial and the Canadian Community Health Survey, a nationally and provincially representative survey. After harmonizing the survey data to match the eligibility criteria of the trial participants, we adjusted for differences in effect modifiers (ie, baseline bodyweight, sex, age, and race) to estimate the comparative effectiveness of tirzepatide versus insulin degludec for weight loss. We performed subgroup analyses to estimate the clinical effectiveness of tirzepatide by region, as well as by age and sex. Then, based on a decision tree model, we used a Bayesian approach to estimate the short-term cost-effectiveness of tirzepatide from the perspective of a Canadian payer. We compared incremental cost-effectiveness ratios (ICERs) based on the original and transported treatment effects.

RESULTS:

The trial and transported effects both showed clinical benefit of tirzepatide for weight loss. These benefits were demonstrated across all provinces and territories, and across age and sex categories. The trial effects, reflecting efficacy, were larger than the transported effects. Although the incremental costs were similar, the reduced incremental benefits estimated with the transported effects resulted in a higher ICER. For tirzepatide compared with insulin, the ICER was $599.40 under the transported scenario versus $577.40 under the original trial scenario.

CONCLUSIONS:

Our study demonstrates the feasibility of generating locally relevant evidence using transportability analysis and highlights the importance of deriving locally representativeness estimates for local decision making.

2026-12-01·Metabolism open

Real-world treatment-transition pathways and dosing patterns of insulin degludec/liraglutide in Chinese adults with type 2 diabetes

Article

作者: Wang, Weihao ; Wang, Xiaoxia ; Zhang, Jie ; Pan, Qi ; Man, Fuli ; Guo, Lixin

Background and aims:

To describe real-world treatment-transition pathways, early IDegLira dosing patterns, treatment simplification, and observed short-term clinical outcomes among Chinese adults with type 2 diabetes (T2D).

Methods:

This multicenter, non-interventional, retrospective observational registry included 1499 adults with T2D who initiated IDegLira in routine practice across 13 provinces and regions in China from April 2022 to December 2023. The five mutually exclusive prior-treatment pathways were non-injectable therapy, basal insulin, multiple daily injections (MDI), insulin plus GLP-1RA, and GLP-1RA-based therapy. Treatment decisions were physician-directed. Eligible patients had documented continuous use of once-daily IDegLira (the fixed-ratio combination [FRC]) for at least 3 months. Early dosing was defined as the starting dose, dose titration, and dose documented at approximately 12 weeks. Exploratory linear models estimated crude and covariate-adjusted between-pathway differences in paired HbA1c and body-weight change.

Results:

Baseline HbA1c was available for 1374 patients (9.05 ± 1.78%) and week-12 HbA1c for 498 patients (7.44 ± 2.29%). Among 480 patients with paired baseline and week-12 HbA1c data (all enrolled in the final study period), mean HbA1c decreased from 9.11 ± 2.09% to 7.45 ± 2.28% (mean change -1.66 ± 2.23 percentage points; P < 0.001). Among the week-12 evaluable population, 21.08%, 47.39%, 81.73%, and 89.36% had HbA1c ≤ 6.5%, <7.0%, <7.5%, and <8.0%, respectively. Among 487 patients with paired baseline and week-12 body-weight data (all from the final study period), mean body weight decreased from 75.48 ± 11.12 to 72.72 ± 10.56 kg (mean change -2.76 ± 4.93 kg). In exploratory adjusted models, HbA1c reductions were smaller after basal insulin (mean difference +0.82 percentage points, 95% CI 0.37 to 1.27) and MDI (+1.25, 95% CI 0.53 to 1.98) than after non-injectable therapy, whereas no overall adjusted pathway association was observed for body-weight change (global P = 0.606). The mean starting dose was 14.46 ± 4.06 U and the mean week-12/current dose was 16.72 ± 4.55 U among available cases. Prandial insulin discontinuation was recorded in 269/301 MDI patients (89.37%); concurrent paired HbA1c and systematic post-initiation safety data were unavailable for this subgroup.

Conclusions:

This study describes real-world treatment-transition and dosing patterns for IDegLira across heterogeneous prior therapies. Glycemic findings are based on the week-12 evaluable population (498 of 1499 patients, all enrolled in the final study period); among 480 patients with paired baseline and week-12 HbA1c data, mean HbA1c decreased by 1.66 percentage points. The study had no comparator group and no basis for causal inference. The findings are descriptive and hypothesis-generating, and may inform clinical discussions and future comparative studies.

2026-12-01·DIABETES RESEARCH AND CLINICAL PRACTICE

Hospitalization outcomes in adults with type 2 diabetes mellitus treated with once-weekly insulin efsitora versus once-daily basal insulins: A post hoc analysis of the QWINT-1 to −4 randomized trials

Article

作者: Guerci, Bruno ; Shyam, C P ; Mushala, Bellina ; Galindo, Rodolfo J ; Threlkeld, Rebecca J ; Goldyn, Andrea ; Philis-Tsimikas, Athena

AIMS:

To describe hospitalization and associated outcomes using pooled data from QWINT-1-4 trial participants.

METHODS:

The multicenter, open-label, treat-to-target phase 3 QWINT-1 through QWINT-4 clinical trial program randomized adults with type 2 diabetes mellitus (T2D) toonce-weekly insulin efsitora alfa (efsitora)versus once-daily basal insulin comparators (insulin glargine: QWINT-1, QWINT-4; insulin degludec: QWINT-2, QWINT-3). This exploratory, post hoc analysis pooled data from QWINT-1-4 trials of participants receiving once-weekly efsitora(N = 1883) or once-daily basal insulin comparators (comparators, N = 1556). Unadjusted summary statistics by treatment group are reported for hospitalization incidence, duration of hospital stay, treatment discontinuation, glycated hemoglobin (HbA_1c), insulin doses, and hypoglycemia rates.

RESULTS:

Overall, 173 (9.2 %) participants receiving once-weekly efsitora and 110 (7.1 %) receiving once-daily comparators (p = 0.17) were hospitalized. The duration of hospital stay was numerically similar for participants receiving efsitora (median 5.0 days) or comparators (median 5.0 days). Permanent treatment discontinuation, primarily driven by adverse events, was more frequent among efsitora-treated (26.6 %) than comparator-treated (16.4 %) participants (p = 0.03). Mean HbA_1c, insulin doses, and hypoglycemia rates before and after hospitalization were numerically similar in both groups.

CONCLUSIONS:

Once-weekly efsitora or once-daily insulin treatment does not appear to impact duration of hospitalization or glycemic parameters before or after hospitalization.

CLINICALTRIALS:

govidentifiers: NCT05662332 (QWINT-1), NCT05362058 (QWINT-2), NCT05275400 (QWINT-3), NCT05462756 (QWINT-4).

451

项与德谷胰岛素相关的新闻（医药）

2026-10-23

·PharmExpress

一天吃透一家药企｜联邦制药

▌导语联邦制药很难用单一标签概括，收入底盘仍依赖抗生素中间体、原料药和胰岛素制剂，但过去两年真正让它回到行业聚光灯下的是尚处III期临床的三靶点减重分子UBT251。2025年3月，联邦生物将UBT251大中华区以外权益授予诺和诺德，首付款2亿美元，里程碑总额最高18亿美元，另加海外净销售额分层提成，首付款到账速度与金额在中国创新药出海交易中处于头部区间。2026年7月，联邦制药已收到与该分子全球II期临床相关的1350万美元里程碑付款，该笔款项已扣除丹麦预缴税。理解其现阶段价值需同时看三条线，传统业务现金生成能力能否覆盖转型成本，UBT251海外临床节奏能否持续提供里程碑催化，动保业务能否从边缘板块成长为有意义的第二曲线。三者并非并列，而是在一条时间轴上接力，传统业务决定底线，动保决定中期增量，UBT251决定远期天花板。企业画像标签： • 抗生素中间体与原料药规模制造底座 • 国内胰岛素集采A组中标企业 • GLP-1/GIP/GCG三靶点分子的对诺和诺德授权方 • 原料药—制剂一体化成本结构 • 动保业务处于放量前段的综合性制药集团核心优势： • 中间体—原料药—制剂的一体化自供体系，使胰岛素在集采报价中具备成本缓冲空间。 • UBT251的中国II期减重数据在24周维度展现出可比较的减重幅度，且已获得诺和诺德的全球开发背书。 • 动保业务2026年上半年收入8.23亿元，同比增长45.8%，畜禽基本盘之外，宠物药与海外注册构成增量方向。客观挑战： • 2026年上半年归母净利润3.48亿元，同比下降81.6%，中间体与原料药价格下行叠加制剂集采价格压力，盈利修复节奏尚不清晰。 • UBT251的海外权益已授出，联邦制药在海外临床推进中的直接控制力有限；国内III期刚启动，距离自身体系内的商业化兑现仍有距离。 • 胰岛素集采续约虽维持A组身份，但价格体系长期承压，制剂端的利润率弹性受到结构性限制。一、企业发展简史联邦制药起家于抗生素。1990年蔡金乐在香港创办联邦制药厂有限公司，随后在珠海、中山、开平、成都、内蒙古等地建厂，以青霉素类中间体和原料药规模化制造进入大陆市场，2007年在港交所主板上市。发酵工艺、成本控制和大宗品种全球供应效率构成其核心能力，也奠定此后二十余年的现金流底色。第一次转型发生在2010年前后，方向是胰岛素。联邦制药在珠海建设胰岛素原料与制剂基地，人胰岛素和甘精胰岛素先后获批，成为国内较早同时具备二代与三代胰岛素生产能力的企业。转型时机不算热门，但公司把原料药端的成本纪律复制到生物药生产。2021年第六批国采胰岛素专项中6个产品均以A组中标，2024年续标维持A组，续标意向量同比增长38.23%，采购基础量同比增长52.5%。第二次转型从2020年后加速，方向是创新药与动保。抗生素周期带来的现金被投向代谢、自免和眼科管线。2025年3月，诺和诺德获得UBT251大中华区以外权益，首付款2亿美元，里程碑总额上限18亿美元，联邦制药保留大中华区权利。交易更接近对早期分子和平台能力的背书，而非成熟品种商业化授权，UBT251当时处于早期临床阶段，诺和诺德看重的是其在GLP-1/GIP/GCG三靶点上的差异化信号。表1 股权架构速览二、核心技术平台联邦制药的技术布局沿已有制造能力向外生长，而非单点突破。生物药端的核心资产是多肽与长效蛋白的工艺开发能力，UBT251和司美格鲁肽、德谷胰岛素等品种共享这一底层能力；化药端延续了抗生素时期积累的发酵与合成工艺，并向JAK1抑制剂、RASP抑制剂等小分子延伸；动保端把畜禽用抗生素的经验迁移至宠物药和水产药。截至2026年3月，公司在研项目超过100项，科研及技术人员超过1000人。表2 核心技术平台概览研发基础上，2025年度研发投入10.05亿元，同比上升2.0%，其中费用化9.21亿元、资本化0.84亿元；开发中的人用药新产品42项，其中1类新药23项；动保开发中新产品60项。研发投入的绝对规模在港股药企中不算突出，但考虑到其收入体量和仿制药现金牛属性，研发强度处于“聚焦式投入”区间，而非广撒网式铺管线。三、管线全景拆解表3.1 核心已上市/近上市品种表3.2 重点临床III期/NDA阶段品种早期管线中，值得留意的是IL-4Rα/TSLP双抗、IL-2融合蛋白和神经肽Y2受体拮抗剂。这些分子的共同特征是不追求“首发”，而是在已验证的通路中寻找给药频率、安全性或联合用药的差异化位置。联邦制药的研发策略倾向于在机制风险相对可控的靶点上做工程优化，而非押注全新生物学。四、商业化布局国内市场国内市场的核心逻辑是“集采存活者”的现金流纪律。胰岛素产品依托集采A组身份维持院内准入，利拉鲁肽选择京东健康作为线上渠道，试图在慢病管理场景中建立品牌认知。2025年制剂产品对外销售收入66.98亿元，其中许可费收入14.42亿元；剔除授权收入后，制剂端2026年上半年销售收入同比增长8.6%，说明成熟品种的实际经营仍具韧性。海外战略海外布局分两条线。现阶段更具实质意义的是平台级License-out：UBT251与诺和诺德的交易，首付款2亿美元、里程碑上限18亿美元，联邦制药的角色从“产品供应方”切换为“早期分子提供方+大中华区权益持有者”。2026年上半年已确认部分里程碑许可收入，后续里程碑的兑现节奏与诺和诺德的全球临床进度绑定。另一条线是自主出海，以胰岛素制剂向新兴市场的注册与出口为代表，战略意义在于渠道铺垫和产能消化，而非短期利润弹性。表4 代表性海外交易业务结构三层梯队： · 胰岛素与抗感染制剂是短期压舱石，提供集采框架内的现金流和产能利用率； · 动保业务是中期增量，2026年上半年45.8%的增速使其从“小板块”向“值得单独关注的利润单元”过渡，券商预计全年收入约15亿元； · UBT251及代谢管线是远期增长极，其价值兑现高度依赖海外临床读出和大中华区商业化节奏。五、管理层表5 关键管理层联邦制药治理结构呈现家族控制与职业财务、销售执行层结合的特征。蔡海山从质控岗位成长为主席，说明公司决策权重偏向生产与质量侧，而非BD或临床开发侧。UBT251授权诺和诺德可能是由研发团队与外部顾问共同推动，而非顶层长期以BD为核心战略的结果。六、竞争壁垒与财务拆解联邦制药的壁垒不在单一分子的专利厚度上，而在几层相互咬合的结构中。一是中间体—原料药—制剂一体化，使胰岛素和抗感染制剂在集采报价中拥有从上游成本到下游产能的缓冲空间。二是胰岛素集采的“存活者席位” ，两轮续约维持A组，院内准入和采购量基础具有制度惯性。三是生物制品分段生产的先发资质，利拉鲁肽作为分段生产试点品种，在产能调度和质量体系上形成了短期难以复制的门槛。四是UBT251的诺和诺德背书，这笔交易本身不构成永久壁垒，但它为联邦制药后续代谢分子的对外合作提供了可参照的定价锚和谈判信用。表6 近年关键财务指标 2025年利润下滑主要拖累来自中间体和原料药，中间体对外销售收入16.12亿元，同比下降39.4%，原料药收入49.00亿元，同比下降23.1%。制剂端因UBT251授权首付款确认14.42亿元许可费收入，表观增速被抬高，剔除后仍受集采价格压力。2026年上半年营收61.66亿元、归母净利润3.48亿元，同比分别下降18.0%和81.6%，中间体价格尚未趋势性修复，2025年同期含授权收入的高基数又放大了降幅。研发投入从2024年约9.86亿元增至2025年10.05亿元，仍集中于代谢与自免。2025年经营现金流净额约37.50亿元，较2024年改善，但2026年上半年收缩至约0.35亿元，传统业务造血与转型投入的缺口扩大，后续对授权里程碑和动保放量的依赖上升。七、行业竞争格局以甘李药业和通化东宝作参照，是因为三者都受胰岛素集采这一核心变量影响，但选择了不同的对冲路径。甘李药业2025年营收40.52亿元，归母净利润11.44亿元，国内制剂销售收入34.30亿元，集采放量后的恢复较明显；通化东宝2025年营收29.47亿元，归母净利润12.19亿元，胰岛素类似物销量同比增长超过100%，产品结构升级明显。联邦制药胰岛素体量与两者接近，但收入中中间体和原料药占比更高，集采对利润的传导路径并不完全相同。表7 竞争格局对比联邦制药在国内药企中的独特位置，是既有大宗制造的成本底盘，又有一款被全球代谢领域头部企业选中的早期分子。甘李药业和通化东宝更接近专科药企在集采后的修复与结构升级，联邦制药则更像综合制造企业把创新期权变现。前两者更依赖胰岛素单一赛道的份额与价格，联邦制药的上行空间部分来自UBT251海外里程碑，也要承担授权模式下控制力外移的代价。八、现存挑战与未来看点表8.1 现存挑战速览表8.2 未来看点速览总结联邦制药当前介于有创新管线的仿制药现金牛和有产业化底座的Biotech之间。它不是纯粹Big Pharma，创新管线尚不足以在收入端接替传统业务，也不是典型Biotech，拥有中间体、原料药、制剂一体化产能和稳定的胰岛素集采份额。其转型路径可概括为用大宗制造成本能力守住现金流底线，用胰岛素集采席位维持制剂规模，再用三靶点分子打开创新叙事上限。短期业绩不依赖UBT251，但估值弹性和市场关注度很大程度上由UBT251海外进展定义。核心价值不在管线数量，而在于这家制造型药企在组织惯性中完成了一笔被全球代谢龙头定价的早期分子交易，证明其研发能力在特定靶点达到国际可比水平，但尚未证明这种能力可以系统性重复。重点跟踪： • 6-APA及中间体价格走势：传统业务利润能否止血，是转型从容度的基础判断。 • UBT251中国III期入组进度：入组速度影响国内商业化时间表的可信度。 • 诺和诺德海外临床启动与入组节奏：里程碑收入的前瞻信号。 • 动保季度收入能否维持在40%以上增速：决定第二曲线是否从“亮眼”变为“可依赖”。 • 胰岛素集采续约政策信号：下一轮价格规则的任何吹风都会影响制剂端的中期利润率假设。 • TUL01101 III期启动时间：JAK1抑制剂能否在自免领域形成第二条可验证的创新管线。【免责与版权声明】本文内容基于公开资料整理。数据截止：2026年9月30日本文内容仅供医药行业学术交流，不构成诊疗、用药、投资及商业决策建议。创新药行业存在临床失败、政策变动、专利纠纷等多重风险，所有判断与决策请自行尽调、风险自担。本文为原创内容，受著作权法保护，未经授权禁止洗稿、摘抄、商用改写，非商用转发请注明来源，内容具备时效性，仅供阶段性参考。

2026-10-23

·PRNewswire

Novo's Awiqli® receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes

Awiqli® offers children 10 years and older a once-weekly basal insulin alternative, reducing basal injection frequency from seven times per week to one1 As type 2 diabetes incidence rates among youth continue to rise,² Awiqli® may help reduce administration barriers associated with daily basal insulin injections and provide families access to more individualized care This approval of Awiqli® reflects Novo's ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes and their caregivers PLAINSBORO, N.J., Oct. 23, 2026 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first once-weekly, long-acting basal insulin, as an adjunct to diet and exercise to improve glycemic control (blood sugar) in children 10 years of age and older with type 2 diabetes.1 This approval offers a once-weekly basal insulin treatment option, which reduces the frequency of weekly basal injections from seven to one per week.1 "Individuals with type 2 diabetes and their families seek treatment options that may allow for more individualized care. Awiqli® reduces basal insulin injections from seven to one per week, which may help patients find a basal insulin routine that feels more manageable," said Michael Radin, MD, executive medical director at Novo. "It is important to continue to discover advanced treatments for the populations that need them today." Type 2 diabetes in children and adolescents is a growing public health challenge, as more young people are being diagnosed each year with this chronic disease that requires ongoing care and caregiver support.3 According to a modeling study, it's anticipated that the number of people ≤19 years old with type 2 diabetes is estimated to reach nearly 84,000 by 2050.4 Healthy nutrition, physical activity, and family support are important aspects of care for type 2 diabetes.2 However, for some young people, these measures may not be enough, potentially leading to complications related to this disease.5 Novo's approach to pediatric care emphasizes a comprehensive model of support – promoting healthy nutrition, regular physical activity, and diabetes education, alongside proven, age-appropriate treatment options for children and adolescents living with type 2 diabetes.2 This approval is supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus and a single-dose pharmacokinetic study completed in pediatric patients that evaluated the pharmacokinetic properties of once-weekly Awiqli® injection in pediatric patients (10 to <18 years of age) with type 2 diabetes.6 These results support the use of Awiqli® in pediatric patients (at least 10 years of age and older), along with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program.6,9 Common side effects of Awiqli® may include: hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.1 "Children with type 2 diabetes face an aggressive disease trajectory and achieving sustained glycemic control in children with type 2 diabetes remains a major challenge. We need treatments that are not only effective but options that work for different patient routines. Having alternative options available for basal insulin therapy allows patients to find a treatment that works best for them and their lifestyle and helps them manage their type 2 diabetes. For more than 20 years daily basal insulin injections have been a main form of treatment in pediatric diabetes care, but children living with type 2 diabetes may face challenges staying on a daily treatment routine," said Eda Cengiz, MD, MHS Professor of Pediatrics at the University of California, San Francisco. "Having an FDA-approved, once-weekly basal insulin injection available could provide new alternatives for pediatric clinical care. Offering a once-weekly basal insulin may help reduce administration barriers associated with daily insulin injections and provide clinicians and families access to more individualized care." Awiqli® is available at more than 70,000 pharmacies nationwide. More information can be found at . Please see below for Important Safety Information and please click here for the full Prescribing Information. About Awiqli ® Awiqli® (insulin icodec-abae) injection 700 units/mL is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes.1 Awiqli® is designed as an alternative to daily basal insulin and its FDA approval is supported by the ONWARDS clinical program, which evaluated its efficacy and safety across insulin-naive patients and previously treated with insulin patient populations living with type 2 diabetes. This approval is supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus and a single-dose pharmacokinetic study completed in pediatric patients that evaluated the pharmacokinetic properties of once-weekly Awiqli® injection in pediatric patients (10 to <18 years of age) with type 2 diabetes.6 These results support the use of Awiqli® in pediatric patients (at least 10 years and older), along with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program.6-10 Awiqli® is administered once-weekly on the same day each week using the Awiqli® FlexTouch® pen.1 Awiqli® is approved in the US, EU, and 18 additional countries, with market-specific indications for diabetes. What is Awiqli? Prescription Awiqli® (insulin icodec-abae) injection 700 units/mL is a long-acting insulin (U-700) that is used to control high blood sugar in adults and children who are 10 years of age and older with type 2 diabetes mellitus It is not known if Awiqli® is safe and effective in children less than 10 years of age Awiqli® is available in 1 concentration: U-700 Important Safety Information Do not share your Awiqli ® FlexTouch ® pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli ® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli ® dosage. The dosage of Awiqli ® is different from other injectable medicines used to treat diabetes. Always make sure that you select the correct dosage of your Awiqli® FlexTouch® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen. Do not dial the maximum single dosage (700 units) of your Awiqli® FlexTouch® pen, unless prescribed by your healthcare provider. Do not use a syringe to withdraw Awiqli® from your pen. Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli® FlexTouch®. Who should not take Awiqli ® ? Do not take Awiqli ® if you: are having an episode of low blood sugar (hypoglycemia) have an allergy to Awiqli® or any of the ingredients in Awiqli®. See the full Patient Information for a complete listing of ingredients in Awiqli® Before taking Awiqli ® , tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems take other medicines, especially ones called TZDs (thiazolidinediones) have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli ® are pregnant, planning to become pregnant, or are breastfeeding are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements Talk to your health care provider about low blood sugar and how to manage it. How should I take Awiqli ® FlexTouch ® ? Read the Instructions for Use that come with your Awiqli® FlexTouch ® pen Your healthcare provider should show you how to use Awiqli ® FlexTouch ® pen before you use it for the first time Take Awiqli® exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli® FlexTouch ® pens are made to deliver your insulin dose in units Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to. The amount of insulin and best time for you to take your insulin may need to change if you take different types of insulin Inject Awiqli® FlexTouch ® 1 time each week on any day of the week on the same day each week If you need to change the day of the week, you may do so if your last dose has been at least 4 days If you have missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken If more than 4 days have passed, skip the missed dose and take your next Awiqli® dose on your regularly scheduled day. Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them Never inject Awiqli® FlexTouch ® into a vein or muscle or use Awiqli® in an infusion pump Never use a syringe to remove Awiqli® from the FlexTouch® pen Do not dilute or mix Awiqli® with any other insulin or solution Awiqli® FlexTouch ® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen) Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the exact same spot for each injection Do not inject where the skin has pits, is thickened, or has lumps Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin Keep Awiqli and all medicines out of the reach of children. What should I avoid while taking Awiqli ® ? Do not drive or operate heavy machinery, until you know how Awiqli® affects you Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol What are the possible side effects of Awiqli ® ? Awiqli ® may cause serious side effects that can be life-threatening, including: Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, fast heartbeat, blurred vision, slurred speech, shakiness, anxiety, irritability, mood changes, hunger and headache Severe allergic reactions (whole body reaction). Stop using Awiqli and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat or sweating Low potassium in your blood (hypokalemia) Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Awiqli®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness Common side effects may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion These are not all the possible side effects of Awiqli®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please click here for the full Prescribing Information. Novo is the global healthcare company that believes lasting health starts now. For over a century, we've combined leading scientific expertise with a deep understanding of people's lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Through our partnerships, programs and investments, we're working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. In the United States, Novo has a 40-year presence, is headquartered in New Jersey and employs approximately 10,000 people. For more information, visit novonordisk-us.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube. AWIQLI, NOVO NORDISK, NOVO, and the Apis Bull Logo are trademarks owned by Novo Nordisk A/S. © 2026 Novo Nordisk All rights reserved. US26AWQ00090 October 2026 _______________________ References: Awiqli® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc. American Diabetes Association Professional Practice Committee for Diabetes. (2026). 14. Children and adolescents: Standards of Care in Diabetes—2026. Diabetes Care, 49(Supplement 1), S297–S320. Reinehr T. Type 2 diabetes mellitus in children and adolescents. World J Diabetes. 2013;4(6):270-281. doi:10.4239/wjd.v4.i6.270 Imperatore G, Boyle JP, Thompson TJ, et al. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes Care. 2012 Dec;35(12):2515-20. doi: 10.2337/dc12-0669. PMID: 23173134; PMCID: PMC3507562 Bjornstad P, Drews KL, Caprio S, et al; TODAY Study Group. Long-term complications in youth-onset type 2 diabetes. N Engl J Med. 2021;385(5):416-426. doi:10.1056/NEJMoa2100165 Van Name M, Ásbjörnsdóttir B, Gomes MM, et al. Pharmacokinetic properties of once-weekly insulin icodec in children and adolescents with type 2 diabetes. Pediatr Diabetes. 2025;2025:5514927. doi:10.1155/pedi/5514927 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;330(3):228–237. doi:10.1001/jama.2023.11313 Rosenstock J, Gowda A, Liang B. Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med. 2023;389(16):1533. doi:10.1056/NEJMc2310221 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 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 SOURCE Novo Nordisk 21% more press release views with Request a Demo

上市批准临床3期

2026-10-22

·ganlee.com.cn

快速起效，无需起始负荷剂量！甘李药业胰岛素周制剂路达胰岛素与依柯胰岛素头对头Ⅲ期研究SUPER-8成功达到主要研究终点

2026年10月16日，甘李药业股份有限公司（以下简称“甘李药业”，股票代码：603087.SH）宣布，公司自主研发的超长效基础胰岛素周制剂路达胰岛素（Insulin Ludefen）注射液在中国开展的评价其与依柯胰岛素注射液（诺和期®）有效性和安全性的头对头关键Ⅲ期临床研究（SUPER-8）达到主要研究终点。 SUPER-8：在既往接受基础胰岛素治疗的2型糖尿病患者（T2DM）中，路达胰岛素注射液的糖化血红蛋白（HbA1c）降幅非劣效于依柯胰岛素注射液 SUPER-8研究是一项在全国50家研究中心开展的为期26周的Ⅲb期达标治疗临床研究（药物临床试验登记与信息公示平台：CTR20253485），在304例既往接受基础胰岛素（包括甘精胰岛素U100/300、德谷胰岛素、地特胰岛素或中效人胰岛素等）治疗的T2DM患者中，比较路达胰岛素注射液与依柯胰岛素注射液（诺和期®）联合或不联合非胰岛素抗糖尿病药物的有效性和安全性。依柯胰岛素组起始剂量为既往基础胰岛素日剂量×7 ×1.5（负荷剂量），路达胰岛素组为既往基础胰岛素日剂量×7，无额外起始负荷剂量。研究结果表明：路达胰岛素注射液在无需起始负荷剂量的情况下，即可实现与依柯胰岛素注射液相当的控糖效果。治疗26周后，路达胰岛素组HbA1c较基线改善幅度非劣效于依柯胰岛素组（-1.12% vs -1.12%）；组间治疗差异为0.00%（95%CI，-0.16至0.16），满足非劣效标准（P<0.0001）。同时，患者自我血糖监测（SMBG）表明：在转换初期（前12周），路达胰岛素组的空腹指尖血糖水平与依柯胰岛素组相当，并持续至26周。治疗期间两组均未发生严重（3级）低血糖事件；两组试验药物相关低血糖事件发生率相当，无非预期安全性问题。同时值得注意的是，在治疗结束的最后2周，路达胰岛素注射液稳定给药的摩尔剂量是依柯胰岛素注射液的1/2.54（39.4%）。以上数据表明，对于既往使用基础胰岛素进行治疗的糖尿病患者，转换为胰岛素周制剂治疗时，路达胰岛素注射液在带来简便转换方案的同时，可实现与依柯胰岛素同样的降糖疗效和安全性，且给药摩尔剂量只有依柯胰岛素的1/2.54（39.4%）。图.平均空腹指尖血糖随时间变化曲线 SUPER-8详细研究结果计划在未来科学会议上公布，并发表于国际学术期刊。糖化血红蛋白（HbA1c）：反映过去2-3个月平均血糖水平，是评价糖尿病治疗的最有效指标。上述顶线主要疗效结果基于疗效策略（efficacy estimand）下符合方案分析集（PPS）人群得出，安全性终点基于安全性数据集（SS）人群得出。 SUPER-8研究主要研究者刘铭教授表示“当前，周制剂基础胰岛素已成为2型糖尿病长效降糖治疗的重要发展方向，但不同周制剂之间缺少直接的头对头对照数据，临床选择缺乏直接证据支撑。SUPER-8是全球首个直接对标已上市依柯胰岛素注射液的周制剂胰岛素头对头研究，结果表明，路达胰岛素注射液降低HbA1c的疗效具有非劣效性；与此同时，在其他Ⅲ期试验人群中，路达胰岛素对比每日基础胰岛素甘精胰岛素U100、德谷胰岛素还展现出降糖优效。该研究在全球范围内首个填补了周制剂胰岛素之间头对头对比研究的证据空白，有望为全球周制剂基础胰岛素治疗领域提供新的临床选择。” 甘李药业临床医学部负责人赵晶博士表示：“SUPER‑8研究顺利取得顶线结果，是路达胰岛素研发进程中的重要里程碑。这项针对周制剂胰岛素头对头Ⅲ期研究，是全球范围内首次对标已商业化依柯胰岛素注射液的临床试验。本研究证实路达胰岛素注射液核心降糖疗效达到非劣效标准，为国产原创周制剂胰岛素实现与国际标杆产品疗效相当提供了关键临床证据。除此之外，路达胰岛素注射液每周一次给药且无需起始负荷剂量，给药更简便，有助于降低患者的用药门槛，提升长期治疗依从性。未来，公司将加速推进路达胰岛素注射液的国内外临床开发与上市申报，力争为全球2型糖尿病患者带来更便捷、可及性更高的新一代周制剂胰岛素创新疗法。” 声明路达胰岛素：研发代号GZR4，国际非专利名称INN：Insulin Ludefen，暂译：路达胰岛素，实际以国家药典委员会公布为准。关于SUPER系列临床研究项目 SUPER系列研究是甘李药业针对基础胰岛素周制剂路达胰岛素注射液开展的大规模全球III期临床系列研究，旨在全面评估路达胰岛素注射液在糖尿病人群中的治疗效果及安全性。目前在中国已启动4项III期临床试验： SUPER-1研究：为期52周，纳入588例既往未使用过胰岛素治疗的2型糖尿病患者。治疗26周后，路达胰岛素组HbA1c较基线降幅（1.45%）显著优于甘精胰岛素U100组（来得时®）（1.22%），且长期给药下两组均未发生严重（3级）低血糖事件。 SUPER-2研究：为期26周，纳入631例既往接受基础胰岛素治疗的2型糖尿病患者。治疗26周后，路达胰岛素组HbA1c较基线降幅（1.00%）显著优于德谷胰岛素组（诺和达®）（0.58%），且两组均未发生严重（3级）低血糖事件。 SUPER-3研究：为期26周，纳入596例既往接受“基础和餐时胰岛素治疗”或接受“预混胰岛素类似物或双胰岛素类似物治疗”的2型糖尿病患者。在均联合门冬胰岛素治疗26周后，路达胰岛素组HbA1c较基线降幅（1.58%）显著优于甘精胰岛素U100组（来得时®）（1.41%）；路达胰岛素组未发生严重（3级）的低血糖事件，甘精胰岛素U100治疗组报告了3例严重（3级）低血糖事件。 SUPER-8研究：为期26周，纳入304例既往接受基础胰岛素治疗的2型糖尿病患者。治疗26周后，路达胰岛素组HbA1c较基线降幅（1.12%）非劣效于依柯胰岛素组（诺和期®）（1.12%），且两组均未发生严重（3级）低血糖事件。 SUPER-1研究：为期52周，纳入588例既往未使用过胰岛素治疗的2型糖尿病患者。治疗26周后，路达胰岛素组HbA1c较基线降幅（1.45%）显著优于甘精胰岛素U100组（来得时®）（1.22%），且长期给药下两组均未发生严重（3级）低血糖事件。 SUPER-2研究：为期26周，纳入631例既往接受基础胰岛素治疗的2型糖尿病患者。治疗26周后，路达胰岛素组HbA1c较基线降幅（1.00%）显著优于德谷胰岛素组（诺和达®）（0.58%），且两组均未发生严重（3级）低血糖事件。 SUPER-3研究：为期26周，纳入596例既往接受“基础和餐时胰岛素治疗”或接受“预混胰岛素类似物或双胰岛素类似物治疗”的2型糖尿病患者。在均联合门冬胰岛素治疗26周后，路达胰岛素组HbA1c较基线降幅（1.58%）显著优于甘精胰岛素U100组（来得时®）（1.41%）；路达胰岛素组未发生严重（3级）的低血糖事件，甘精胰岛素U100治疗组报告了3例严重（3级）低血糖事件。 SUPER-8研究：为期26周，纳入304例既往接受基础胰岛素治疗的2型糖尿病患者。治疗26周后，路达胰岛素组HbA1c较基线降幅（1.12%）非劣效于依柯胰岛素组（诺和期®）（1.12%），且两组均未发生严重（3级）低血糖事件。关于路达胰岛素注射液路达胰岛素注射液是甘李药业自主研发的一种超长效基础胰岛素周制剂候选药物，每周仅需注射一次，即可有效且平稳地控制一周血糖。路达胰岛素注射液预计将帮助糖尿病患者克服注射障碍，更早起始和持续胰岛素治疗，实现简便高效，长期安全的血糖控制，从而提高患者生活质量。已完成的Ⅲ期临床研究结果表明，每周一次路达胰岛素注射液在2型糖尿病患者中，降低HbA1c的效果优于每日一次的甘精胰岛素U100、德谷胰岛素注射液，与周制剂依柯胰岛素注射液疗效相当。目前，路达胰岛素注射液的全球开发均已进入Ⅲ期临床阶段，有望引领全球胰岛素治疗进入第四代胰岛素时代。前瞻性声明该前瞻性陈述基于我们在陈述之日的预期和假设。由于各种因素，实际结果可能与这些前瞻性陈述中表达的内容存在重大差异，我们不能保证将来会实现这些结果。我们不承担更新或修改任何前瞻性陈述的义务，无论是由于新信息、未来事件或其他原因。关于甘李药业甘李药业股份有限公司（简称：甘李药业，股票代码：603087.SH）作为中国第一家掌握产业化生产重组胰岛素类似物技术的高科技生物制药企业，具备完整胰岛素研发管线。目前，公司拥有六款核心胰岛素产品，包括五个胰岛素类似物品种：长效甘精胰岛素注射液（长秀霖®）、速效赖脯胰岛素注射液（速秀霖®）、门冬胰岛素注射液（锐秀霖®）、预混精蛋白锌重组赖脯胰岛素混合注射液（25R）（速秀霖®25）、门冬胰岛素30注射液（锐秀霖®30）；以及人胰岛素品种：预混精蛋白人胰岛素混合注射液（30R）（普秀霖®30）及相关配套器械，产品覆盖长效、速效、预混三个胰岛素功能细分市场。甘李药业在中国胰岛素第二次集中带量采购中，胰岛素类似物中选协议量居中选企业首位，国内市场基础持续夯实。与此同时，公司国际化进程稳步推进，甘精胰岛素注射液、赖脯胰岛素注射液及门冬胰岛素注射液均已获得欧盟委员会（EC）上市批准，正稳步向全球代谢疾病领域核心参与者迈进。未来，甘李将努力实现糖尿病治疗领域的全面覆盖，进一步提升公司在糖尿病治疗领域的市场竞争力。公司还将积极开发新的化学药和生物新药，重点关注代谢性疾病、心血管疾病和其他治疗领域。

临床结果临床3期临床成功

100 项与德谷胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09727	德谷胰岛素	A10AE06	DB09564

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	中国	Novo Nordisk A/S	2017-09-20
糖尿病	日本	Novo Nordisk Pharma Ltd.	2012-09-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床3期	美国	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	法国	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	德国	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	俄罗斯	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	南非	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	英国	Novo Nordisk A/S	2009-09-01
低血糖	临床1期	德国	Novo Nordisk A/S	2009-08-01

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临床结果

适应症

分期

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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


DEAL-2 (ADA2026)	N/A	2型糖尿病	176	Insulin Degludec (Dose Check App)	製鬱選鹹糧窪廠簾選壓(糧憲獵獵膚繭網網顧膚) = 齋壓壓鹹襯繭構積簾餘觸築憲鑰襯網構製艱夢 (選憲蓋構齋遞積顧膚窪 ) 更多	积极	2026-06-20
NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	临床3期	2型糖尿病	-	Once-Weekly Insulin Icodec	網齋選鏇淵鬱鬱觸淵餘(願觸獵鹽壓壓廠選簾糧): P-Value = 0.0152	积极	2025-02-28
				Once-Daily Insulin Degludec
NCT04795531 (ONWARDS 1-6 \| ONWARDS 1-5 \| ONWARDS 3, CTgov)	临床3期	2型糖尿病	588	placebo+insulin icodec (Insulin Icodec)	獵糧構襯觸繭壓觸醖製(廠鹽壓範獵憲夢壓顧憲) = 選範獵鏇積鏇構淵選糧齋窪餘願衊衊廠鹽鑰齋 (製衊廠鹽遞壓範蓋願築, 0.05) 更多	-	2024-12-04
				Insulin Degludec (Insulin Degludec)	獵糧構襯觸繭壓觸醖製(廠鹽壓範獵憲夢壓顧憲) = 簾積顧蓋鏇鬱齋廠廠繭齋窪餘願衊衊廠鹽鑰齋 (製衊廠鹽遞壓範蓋願築, 0.05) 更多
NCT05243628 (ABC, CTgov)	临床4期	1型糖尿病	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	壓繭廠顧壓廠醖鹹網襯(鏇襯積憲齋鏇糧鬱鹹顧) = 鏇壓獵夢夢衊襯醖積窪構襯夢夢簾遞齋窪艱糧 (鹹鏇積鑰鹹鏇網廠鏇蓋, 0.58) 更多	-	2024-10-18
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	壓繭廠顧壓廠醖鹹網襯(鏇襯積憲齋鏇糧鬱鹹顧) = 觸壓窪簾憲鏇壓製衊築構襯夢夢簾遞齋窪艱糧 (鹹鏇積鑰鹹鏇網廠鏇蓋, 0.29) 更多
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)	願鹽淵範鏇構糧鏇選鹹(夢蓋餘廠醖網遞醖壓鹽) = 糧築蓋壓鹹鹽鏇窪餘蓋構醖網築觸構簾壓鹽顧 (壓鑰蓋顧構獵膚觸壓簾, 醖觸獵鹹夢蓋鑰範壓繭 ~ 膚構構構顧築蓋夢鬱襯) 更多	-	2024-07-29
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	願鹽淵範鏇構糧鏇選鹹(夢蓋餘廠醖網遞醖壓鹽) = 膚鹽齋衊築膚壓鏇餘鹽構醖網築觸構簾壓鹽顧 (壓鑰蓋顧構獵膚觸壓簾, 窪鏇壓窪構餘築鏇獵衊 ~ 憲觸築鬱壓艱醖膚範願) 更多
ADA2024 人工标引	N/A	2型糖尿病	159	fixed-ratio insulin degludec/liraglutideinsulin degludec/liraglutide (Intervention regimen)	糧鹽廠廠願鏇淵鑰齋鬱(鑰壓膚憲選壓網艱選鹽) = 鏇鹽廠築選齋簾窪鑰醖積餘簾壓襯淵遞鏇憲構 (獵餘襯繭簾憲窪鬱獵築, 0.4) 更多	积极	2024-06-21
				Standard care	糧鹽廠廠願鏇淵鑰齋鬱(鑰壓膚憲選壓網艱選鹽) = 鹹願網遞廠糧窪獵鹹繭積餘簾壓襯淵遞鏇憲構 (獵餘襯繭簾憲窪鬱獵築, 0.6) 更多
NCT04623086 (Pubmed \| Diabetes Obes Metab)	临床3期	1型糖尿病	37	U-100G + degludec	窪繭製窪觸糧觸壓廠觸(糧糧範艱醖製衊網膚願) = 願網築網顧壓鹽憲廠鏇憲簾壓餘簾蓋獵窪膚膚 (衊鹹憲願選鹹選顧壓選 )	积极	2024-05-01
				Placebo + degludec	-
NCT05434559 (Pubmed \| Diabetes Technol Ther) 人工标引	N/A	1型糖尿病	486	Insulin degludec	淵積艱醖壓淵製壓餘鏇(積構製夢齋構選鹽襯餘) = 簾夢鹽鑰構襯糧繭窪鑰襯構構齋鏇顧衊構壓鹽 (積壓淵繭餘選構遞衊繭 ) 更多	积极	2024-03-21
				Other long-acting insulins	淵積艱醖壓淵製壓餘鏇(積構製夢齋構選鹽襯餘) = 憲壓積選網淵簾壓簾齋襯構構齋鏇顧衊構壓鹽 (積壓淵繭餘選構遞衊繭 ) 更多
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	临床2期	-	912	Once-weekly insulin efsitora alfa	膚憲繭鹽鬱醖衊觸衊齋(壓選窪遞構膚餘鑰鏇鬱) = 製衊鹽淵餘蓋構夢鹹壓鬱鬱鹽範願鹽淵膚製鬱 (鹹鹽選製遞鏇餘鬱艱鏇 ) 更多	积极	2023-10-03
				Once daily degludec	膚憲繭鹽鬱醖衊觸衊齋(壓選窪遞構膚餘鑰鏇鬱) = 簾醖選鬱艱願鏇繭鬱糧鬱鬱鹽範願鹽淵膚製鬱 (鹹鹽選製遞鏇餘鬱艱鏇 ) 更多
NCT04795531 (ONWARDS 3, EASD2023)	临床3期	2型糖尿病	588	Insulin icodec	鑰鹽鬱齋積遞繭願糧鏇(鏇廠鹽製製醖網獵願膚): P-Value = <0.0001 更多	积极	2023-10-03
				Insulin degludec