A Multi-centre, Prospective, Single-arm, Non-interventional Study Describing the Use of the Dose Check App in People Living With Type 2 Diabetes Mellitus and Treated With IDegLira in a Real-world Setting in Italy

This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Participants will also be prescribed to use Dose Check app by study doctor. Participants will be asked to install the Dose Check app in their mobile phone, which will be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.

开始日期2024-05-07

申办/合作机构

Novo Nordisk A/S

NCT06449703 / Recruiting临床1期

A Randomized, Open-label, Two-period, Cross-over Trial to Evaluate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Injection Compared With Xultophy® in Healthy Chinese Subjects

The main purpose of the trial is to compare the pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. During the trial period, serials of blood samples will be collected from the participants at two dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.

开始日期2024-05-06

申办/合作机构

通化东宝药业股份有限公司

NCT06408532 / Not yet recruiting临床4期IIT

The Evaluation of the Efficacy and Safety of Switching to Once-daily IDegLira in Patients With Type 2 Diabetes Receiving Premixed Insulin Therapy, a Multi-center, Randomized Control Trial

The study aims to evaluate the efficacy and safety of IDegLira in type 2 diabetes who have failed premixed insulin therapy. The study plans to enroll 256 participants with inadequate glycemic control despite twice-daily subcutaneous injections of premixed insulin and metformin. Participants will be randomly assigned to either the premixed insulin dose optimization group (control group) or IDegLira once daily group, and the difference in change in glycated hemoglobin levels from baseline to 16 weeks of treatment will be assessed between the two groups.

开始日期2024-04-30

申办/合作机构

北京大学人民医院

100 项与德谷胰岛素/利拉鲁肽相关的临床结果

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100 项与德谷胰岛素/利拉鲁肽相关的转化医学

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100 项与德谷胰岛素/利拉鲁肽相关的专利（医药）

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129

项与德谷胰岛素/利拉鲁肽相关的文献（医药）

2024-03-01·Diabetes/metabolism research and reviews

Efficacy and safety of fixed‐ratio combination insulin degludec/liraglutide in type 2 diabetes: A systematic review and meta‐analysis of randomised controlled trials

Review

作者: Xiao, Zilin ; Wang, Rui ; Zhou, Zhiguang ; Luo, Shuoming

Abstract:

Background:

The efficacy and safety of fixed‐ratio combination insulin degludec/liraglutide (IDegLira) for type 2 diabetes (T2DM) were extensively investigated by the global DUAL trials. However, the evidence on its efficacy and safety in T2DM has not been systematically reviewed.

Methods:

Randomized controlled trials published in English that compared IDegLira with placebo or GLP‐1 agonists or insulin in patients with T2DM were selected up to December 2022. Data on the study characteristics, efficacy and safety outcomes were extracted. We compared the efficacy and safety between “IDegLira versus Insulin,” “IDegLira versus GLP‐1RA,” and “IDegLira versus Placebo”. The risk of potential bias was assessed.

Results:

In terms of glycaemic efficacy, IDegLira reduced levels of glycated haemoglobin (HbA1c; weighted mean differences (WMDs) 0.52%, 95% CI 0.33%–0.71%); fasting blood glucose (0.32 mg/dL, 0.14–0.50 mg/dL), and the nine‐point self‐measured plasma glucose (0.25 mmol/L, 0.25–0.36 mmol/L). Furthermore, IDegLira was generally better in the attainment of HbA1c < 7.0% or ≤6.5%, HbA1c < 7.0% or ≤6.5% without weight gain and/or without severe or blood glucose‐confirmed hypoglycaemic episodes. In non‐glycaemic efficacy aspects, IDegLira decreased systolic blood pressure but elevated heart rate. In terms of safety outcomes, IDegLira did not appear to be associated with a risk of hypoglycaemia (RR 1.23, 0.85–1.78) and nocturnal hypoglycaemia (0.89, 0.52–1.52) occurring when compared with other hypoglycaemic agents or placebo.

Conclusions:

IDegLira improves better glycaemic and non‐glycaemic outcomes without weight gain and/or without severe or blood glucose‐confirmed hypoglycaemic episodes in T2DM. Side effects of IDegLira are mild.

2024-01-01·Diabetes therapy : research, treatment and education of diabetes and related disorders

Use of IDegLira to Intensify, Simplify, and Increase Appropriateness of Type 2 Diabetes Therapy: A Real-Life Experience

Article

作者: Serra, Rosalia ; Romano, Isabella

INTRODUCTION:

Fixed ratio combination of insulin degludec and liraglutide (IDegLira) represents an option to revise inappropriate therapies in patients with poorly controlled type 2 diabetes. This study aimed to assess the pattern of use and 1-year effectiveness of IDegLira.

METHODS:

A retrospective chart review was performed to assess changes in glycated hemoglobin (HbA1c) (primary endpoint), fasting blood glucose (FBG), body weight, estimated glomerular filtration rate (eGFR), and lipid profile following IDegLira initiation. Previous versus concomitant diabetes treatments were also compared.

RESULTS:

Overall, 87 patients (mean age 73.9 ± 9.2 years, diabetes duration 18.2 ± 6.7 years, 62.1% men, HbA1c 8.3 ± 1.3%, BMI 30.4 ± 5.5 kg/m²) initiated IDegLira. Previously, 21.8% of patients were treated with oral hypoglycemic agents (OHA group), 47.1% with basal insulin ± OHA (BOT group), 5.8% with GLP-1 RA ± basal insulin (GLP1-RA group), and 25.3% with basal-bolus schemes (BB group). At the first prescription of IDegLira, secretagogues and schemes including two or more OHA were substantially reduced, leaving metformin as the most prevalent OHA (81.6%) used in combination with IDegLira. Starting dose of IDegLira ranged from 18.7 ± 3.1 U (OHA group) to 24.1 ± 4.4 U (BB group). After 1 year, HbA1c was significantly reduced by 1.25% (95% CI - 1.48; - 1.03), FBG by 52.9 mg/dl, and body weight by 2.0 kg. Also, eGFR levels and lipid profile significantly improved. No severe hypoglycemia occurred.

CONCLUSION:

It is possible to proactively review suboptimal or inappropriate diabetes treatment according to the most recent guidelines. Results suggest that initiation of IDegLira was associated with a reduction in drugs to be administered daily and relevant improvements in clinical outcomes.

2023-11-01·Diabetes therapy : research, treatment and education of diabetes and related disorders

Simplification of Complex Insulin Regimens with IdegLira in People with Type 2 Diabetes: Literature Review and Clinical Recommendations.

Article

作者: Ordóñez, J E ; Ramírez, A ; Builes-Montaño, C ; Wandurraga, E

INTRODUCTION:

This study developed a simple algorithm based on clinical results described in medical literature and which allows one to simplify complex insulin regimes with IdegLira to avoid adverse events related to the complexity of some insulin treatments.

METHODS:

We conducted a systematic review of the literature that allowed us to identify studies that evaluated the clinical result of simplifying complex insulin regimes. The authors reviewed the common factors these simpler regimes had, including the type of patients who used them.

RESULTS:

We found nine clinical studies published between 2017 and 2022, eight performed in Europe and one in Latin America. The monitoring time of the studies ranged between 3 and 18 months. The size of the study populations was between 61 and 611 patients (the latter was in five countries). In all studies, HbA1c decreased by 0.6-1.7% and the weight decreased by 0.1-3.11 kg.

CONCLUSIONS:

On the basis of the findings of these studies, we made some recommendations for clinical practice to simplify treatment. The results of these studies support an algorithm that simplifies the treatment of complex insulin regimens.

114

项与德谷胰岛素/利拉鲁肽相关的新闻（医药）

2024-06-28

·奇点网

《科学》：减肥神药，欺骗大脑！韩美科学家联合发现GLP-1RA增加餐前饱腹感的神经机制丨科学大发现

*仅供医学专业人士阅读参考本周二，胰高糖素样肽-1受体激动剂（GLP-1RA）司美格鲁肽的新适应证——长期体重管理——在我国获批，让我国肥胖症患者有了一种全新的治疗选择。从临床研究结果来看，使用GLP-1RA会增加肥胖患者的饱腹感，降低肥胖患者对食物的渴求，最终通过减少热量摄入达到减重的目的。以上现象说明，GLP-1RA可能是通过调节餐前饱腹感达到控制食物摄入量的目的。不过，目前GLP-1RA的靶神经元仍不确定，受GLP-1RA调控的餐前饱腹感神经通路就更是无人知晓了。今天，由韩国首尔国立大学医学院Hyung Jin Choi和美国得克萨斯大学西南医学中心Kevin W. Williams领衔的研究团队，在顶级期刊《科学》上发表一项重磅研究成果[1]，一举破解了上述谜题。他们基于人体和小鼠的研究数据发现，GLP-1RA确实会在我们开始吃东西之前，就激活大脑特定区域的神经元，让我们迅速产生饱腹感。从机制上讲，GLP-1RA可以直接激活下丘脑背内侧核（DMH）中表达GLP-1受体（GLP-1R）的神经元（DMHGLP-1R），促使DMHGLP-1R神经元抑制下游弓状核表达NPY/AgRP的神经元（ARCNPY/AgRP），进而调节饱腹感和食物的摄入。这项研究成果不仅揭示了GLP-1RA调节饱腹感的神经学机制，也为肥胖等代谢疾病提供了新的神经治疗靶点。 ▲ 论文首页截图为了证实GLP-1RA可以调节餐前饱腹感，研究人员首先在肥胖患者身上开展了一项临床试验。在进食的三个不同阶段调查不使用或使用GLP-1RA受试者的饱腹感情况，这三个阶段分别是：基线阶段（看到食物之前），餐前阶段（看到食物到开始吃之前），进食阶段（开始吃之后）。从临床研究结果来看，使用GLP-1RA的受试者，在三个阶段饱腹指数不断攀升；对照组的饱腹指数一开始就比GLP-1RA组低，而且在前两个阶段不断下降，在第三个阶段才升高。不难看出，GLP-1RA确实能提高受试者的餐前饱腹感。 ▲ 研究过程及饱腹感的变化在人体内确认GLP-1RA可以调节餐前饱腹感之后，研究人员接下来就着手寻找GLP-1RA作用的靶神经元和相关的神经通路。他们首先关注的是下丘脑中的ARCNPY/AgRP神经元，因为已知它们与饱腹感和饥饿感关系密切。而且之前的研究也已经发现，GLP-1和GLP-1RA通过调节GABA能神经元抑制ARCNPY/AgRP神经元活性，而发挥抑制作用的GABA能神经元可能就在下丘脑背内侧核（DMH）。既然是寻找GLP-1RA的靶神经元，那么表达GLP-1R的下丘脑背内侧核神经元（DMHGLP-1R）自然就成了研究人员重点关注的对象。通过对小鼠大脑进行3D成像，他们发现DMHGLP-1R神经元确实可以投射到弓状核（ARC）。这也暗示，DMHGLP-1R神经元可能就是ARCNPY/AgRP神经元的上游调节器。 ▲ 下丘脑背内侧核（DMH）和弓状核（ARC）于是他们借助于光遗传学技术，探索了DMHGLP-1R神经元的功能。研究结果表明，激活DMHGLP-1R神经元足以产生饱腹感，而且DMHGLP-1R神经元是调节饱腹感所必需的。他们还基于小鼠模型，通过多种实验手段证实部分DMHGLP-1R神经元确实在开始进食之前，就将外部信息和内部状态连接起来，进而调节进食前的饱腹感。他们还注意到，使用GLP-1RA可增强DMHGLP-1R神经元的功能，抑制DMHGLP-1R神经元的活性，就会消除GLP-1RA诱发饱腹感的能力。在研究的最后，研究人员采用光遗传-电生理环路示踪（CRACM）技术，探索了DMHGLP-1R神经元与ARCNPY/AgRP神经元之间是否存在突触耦合。研究结论是，激活DMHGLP-1R神经元会直接抑制ARCNPY/AgRP神经元。这也证实了DMHGLP-1R→ARCNPY/AgRP这一餐前饱腹感神经回路的存在。 ▲ DMHGLP-1R→ARCNPY/AgRP神经回路总的来说，Hyung Jin Choi/Kevin W. Williams团队的这项研究成果，阐明了GLP-1RA发挥减重作用的核心机制，不仅确定了GLP-1RA的靶神经元，还发现了GLP-1RA能即时调控进食行为的神经回路，加深了我们对餐前饱腹感的认知。未来，这项研究成果，不仅可以优化GLP-1RA的研发，还为肥胖等代谢疾病的治疗提供了新的潜在靶点。参考文献： [1].Kim KS, Park JS, Hwang E, et al. GLP-1 increases preingestive satiation via hypothalamic circuits in mice and humans. Science. Published online June 27, 2024. doi:10.1126/science.adj2537 本文作者丨BioTalker

临床结果临床研究

2024-06-27

·drugs

Exercise + GLP-1 RA Effective for Weight Loss While Preserving BMD

THURSDAY, June 27, 2024 -- For adults with obesity, without diabetes, combining exercise with the glucagon-like peptide-1 receptor agonist (GLP-1 RA), liraglutide , is effective for weight loss, while preserving bone health, according to a study published online June 25 in JAMA Network Open . Simon Birk Kjær Jensen, Ph.D., from the University of Copenhagen in Denmark, and colleagues examined bone health at clinically relevant sites after diet-induced weight loss followed by a one-year intervention with exercise, liraglutide, or both in a secondary analysis of a randomized trial involving adults aged 18 to 65 years with obesity, without diabetes. After an eight-week low-calorie diet, participants were randomly allocated to exercise alone, the GLP-1 RA liraglutide alone, the combination, or placebo for 52 weeks (48, 49, 49 and 49 participants, respectively). The researchers found that the total estimated mean change in weight losses during the study was 7.03 kg in the placebo group and 11.19, 13.74, and 16.88 kg in the exercise, liraglutide, and combination groups, respectively. Bone mineral density (BMD) was unchanged in the combination group versus the placebo group at the hip and lumbar spine. BMD decreased for the liraglutide versus the exercise group at the hip and spine (mean changes, −0.013 and −0.016 g/cm 2 , respectively). "Our findings highlight the importance of combining exercise with GLP-1 RA treatment for bone health," the authors write. Novo Nordisk supplied the liraglutide and placebo pens; Cambridge Weight Plan supplied low-calorie meal replacement products. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

2024-06-26

·药时代

一年少打300多针！全球首款胰岛素周制剂在华获批

正文共：3692字 8图预计阅读时间：9分钟胰岛素周制剂，意味着什么？对患者而言，最直观的感受就是“可以少打针”。保守估计，胰岛素周制剂可将全年基础胰岛素注射次数从365次降低至52次，一年便可少打300多针，极大减轻了患者负担。 2024年6月24日，国家药品监督管理局（NMPA）正式批准了诺和诺德依柯胰岛素注射液（商品名：诺和期®）的上市申请，用于治疗成人2型糖尿病患者。（见图1）图1：诺和期®获批上市（图片来源：NMPA官网）诺和期®是截止目前全球首个且唯一获批的胰岛素周制剂，通过替换长链脂肪酸和氨基酸，使其能够高效可逆地结合白蛋白，从而将半衰期延长至196小时，实现一周仅需一针的给药频率。 “一针一周”，不仅标志着全球胰岛素周制剂治疗时代的开启，还意味着对当前胰岛素治疗困境的破冰。胰岛素治疗困境一直以来，胰岛素作为糖尿病治疗的基石性药物，其重要性不言而喻。尤其是在面对1型糖尿病及口服药物疗效不佳等复杂情况时，胰岛素治疗就是实现快速控制血糖的“最后一道防线”。即便近年来出现了SGLT-2抑制剂、GLP-1受体激动剂等新型降糖药物，胰岛素的地位依然稳固。然而，玉无完玉。胰岛素在实际运用中，患者常会因注射恐惧、临床惰性等因素，最终导致延迟治疗。一项纳入500例患者，200名内分泌医生，100名护士的横断面调查研究显示[1]，无论对于患者还是医务人员，注射相关问题都是起始胰岛素治疗的最常见临床负担。（见图2）图2：该试验评估了注射降糖疗法在患者关注、患者满意度、需要改进的地方及培训负担方面未满足的临床需求根据第十版IDF糖尿病地图显示，我国成人糖尿病患者人数已居世界各国之首，高达1.4亿[2]。然而血糖控制达标的患者仅占16.5%[3]，这一部分原因是由于对糖尿病和胰岛素的错误认知，另一部分原因则与胰岛素治疗下的低依从性密切相关。鉴于注射方式带来的不便，探寻新型给药路径自然而然便成为了科研前沿的焦点，即新型胰岛素主要研发方向之一。（见图3）图3：新型胰岛素的六大研发方向可遗憾的是，在新型胰岛素中，口服胰岛素面临极端pH条件下失活、酶促降解和渗透性不足的挑战，难以跨越胃酸、肠粘膜屏障，且生物利用度较低[4]。而吸入式胰岛素也显露出黏膜纤毛清除效应活跃、大分子穿透能力差等局限性[5]，新型给药途径目前仍需大量时间探索和临床积累。如此困境下，延长胰岛素作用时间，减少注射频率不失为另一条破解之道。而诺和期®的获批，恰是对这一思路的成功实践，为患者提供了更为高效、便捷的治疗选择。长效问题解决后，稳定性呢？针对诺和期®的开发，诺和诺德启动了6项3期ONWARDS系列研究，其中ONWARDS 1～5研究分别针对初治与既往使用胰岛素的2型糖尿病患者（见图4），ONWARDS 6研究则针对1型糖尿病患者。目前所有研究均已完成，且全部达到了主要临床终点[6]。图4：ONWARDS 1～5研究：HbA1c达标率和安全达标率在今年的ADA大会上，诺和诺德对ONWARDS 1～5研究进行了详尽的事后分析，探索了包括不同年龄段、体力活动（PA）相关低血糖的发生概率、不同族裔和种族、GLP-1RA使用情况、肾功能状态等不同层次的患者亚组在内的一系列复杂变量[7]。分析总结得出，诺和期®在对比每日给药的基础胰岛素（OD对照）时，其显著的治疗效果和较低的低血糖发生风险，具有高度的一致性和普遍适用性。总体而言，诺和期®的疗效与安全性不受患者年龄、种族背景、是否合用GLP-1RA治疗、或是肾功能状态的影响，有力证明了该药物在多样患者群体中的稳定性。而“稳定”，就是诺和期®最重要的“必杀技”。一是药物持续释放的稳定，二是面对患者多样性时的疗效稳定。首先是药物持续释放的稳定。一项开放标签、多剂量的1期药理学研究显示[8]，在药代动力学（PK）方面，诺和期®通过每周一次给药方案，患者在连续给药3至4周后可达到稳定的血药浓度平台期。值得一提的是，当首次剂量提升50%可加速稳态形成，患者只需2至3周便可达到稳态。（见图5）图5：诺和期®达到稳态的时间至于药效动力学（PD）方面，诺和期®在达稳态时降糖疗效日间分布接近平均（每日葡萄糖输注率曲线下面积占比为12.0%~16.1%），即血糖控制作用在全天分布均匀。（见图6）图6：诺和期®达到稳态时的降糖疗效分布诺和诺德大中国区医药质量部企业副总裁张克洲认为，胰岛素周制剂的意义并非简单的拉长周期，而是“模拟人体自身胰岛素的分泌状态”，持续且稳定的控糖恰好是诺和期®的特点之一。其次是面对患者多样性时的疗效稳定。在ONWARDS系列研究中，有一项研究尤为瞩目，它也是此次诺和期®在华获批的关键证据之一，ONWARDS 3。这项研究共入组588例T2DM患者，其中，来自中国（大陆13个研究中心和台湾5个研究中心）的患者共145例，构成了研究中最大的患者群体[9]。基于中国患者的高比例基数，诺和诺德对ONWARDS 3中国亚组进行了事后分析，旨在进一步确证在起始胰岛素治疗的中国2型糖尿病患者中，每周一次诺和期®相较于每日一次德谷胰岛素在控糖疗效与安全性的优势[10]。分析结果印证了主要终点的一贯性，即第26周时与德谷胰岛素相比，诺和期®促使HbA1c水平显著降低，差异值为-0.28%（95%置信区间-0.5至-0.05），统计学意义显著（P=0.0152）。（见图7）图7：主要终点（HbA1c自基线至26周的变化）在次要终点上，诺和期®与德谷胰岛素在降低空腹血糖（FPG）方面效果相当，差异微乎其微（ETD为-0.03mmol/L，95%CI-0.55至0.48），P值显示无显著差异（P=0.8965），且两组患者的空腹血糖随访期间的平均变化趋势相似。（见图8）图8：FPG和平均空腹SMPG自基线至第26周的变化在安全性终点上，诺和期®与德谷胰岛素的2级或3级低血糖事件发生率无显著差异，估计率比为1.34（95%CI 0.25,7.27），P值同样表明无统计学意义（P=0.7331），且两组均未报告严重低血糖事件。长期以来，基础胰岛素的研发导向始终围绕“更平缓、更持久、更安全”的目标前进，而诺和期®的上市，不仅是对该目标的显著提升，更是开启了糖尿病治疗的新篇章。获批背后的大“彩蛋” 在诺和期®获批的背后，还有一个“大彩蛋”。即，诺和期®是诺和诺德“中国同创”项目的首个落地成果。首次实现在中国、欧盟和美国同步开展临床试验，同步递交上市申请，欧盟获批仅1个月后就在中国获批，并提前于FDA获批，实现了全球同步获批。让中国患者更早获益于全球创新药。 “中国同创”计划启动于2020年，诺和诺德矢志在2025年后，实现90%以上的全球创新药在中国同步提交审批。这在以往，可是中国医药行业难以触及的梦想。在中国加入ICH之前的很长一段时间里，不说同步研发，仅是想要实现进口药物的同步引进，都是困难重重。受制于当时政策划定的红线，包括必须在海外进入二期临床后方能在中国开展国际多中心研究，海外批准后方可提交国内上市申请，以及国际多中心试验完成后还需重新申报临床，这一系列繁复的“三报三批”流程，导致了新药境内外上市的时间差，一度长达5年以上。面对“重重阻碍”，中国医药改革迅猛且高效，自2015年起逐步废除不合理审评程序，强化政策引导，特别是随着2023年《药审中心加快创新药上市许可申请审评工作规范（试行）》的发布，审批流程显著提速，为诺和期®实现全球同步研发与上市铺就了夯实的政策基石。此外，本土创新能力和丰富的临床资源也为“中国同创”计划的成功实施添砖加瓦。 ONWARDS 3研究的主要研究者母义明教授分享了研究过程中遭遇的艰辛，“尤其是研究的实施阶段，2021年3月至2022年6月，恰逢新冠疫情流行，中国研究者积极克服疫情所导致的各种难以想象的困难，使得试验能顺利推进。” 30多年前，潘长玉教授等糖尿病领域的前辈，开启了内分泌领域中国临床研究的新纪元。如今，接力棒已传递给了更多科研人员手中。诺和期®的获批，不仅仅是诺和诺德“中国同创”计划结出的首个硕果，标志着跨国药企与本土创新生态深度融合的里程碑；也是我国医疗改革深化进程中，推动医药创新与国际接轨、加速新药上市审批制度改革成效的集中体现；更是广大中国糖尿病患者迈向更加高效、便捷治疗新时代的象征。结语自1921年胰岛素被首次发现至今，已有百年历史。历经世纪更迭，胰岛素从最初的动物源形态，逐步演进至人胰岛素、合成胰岛素、胰岛素类似物，直至今日的新型胰岛素革命。可以说，每一次胰岛素的迭代，都深刻推动了糖尿病治疗理念与实践的飞跃。从单一的血糖控制目标，扩展至注重心血管健康与长期生存质量的综合考量，最终迈入以患者为中心，多维度综合管理的的新纪元，诺和诺德一直在为之努力。就在今年1月，诺和诺德公布了诺和期®联用司美格鲁肽周制剂（700U/2毫克/毫升）组合IcoSema的三期COMBINE研究结果。结果显示，在679名使用每日一次基础胰岛素控制不佳的2型糖尿病患者中，每周一次的IcoSema与每日注射一次的甘精胰岛素 U10和门冬胰岛素（每日餐时注射2～4次）相比，在降低HbA1c上显示具非劣效性[11]。此外，诺和诺德旗下亦有多款新一代胰岛素，包含Tresiba、Xultophy、Ryzodeg、Fiasp。 “驱动改变，为世代健康”，相信未来，会有更多慢病领域的患者从不断改变中获益。封面图来源：Pixabay 参考资料： [1]Chen T, et al. Clin Ther. 2020 Aug;42(8):1549-1563. [2]2021 IDF 糖尿病地图; IDF Diabetes Atlas 2021 [3]Wang L, et al. JAMA. 2021, 326(24):2498-2506. [4]Xiao Y,et al. Angew Chem Int Ed Engl. 2020 Nov 2;59(45):19787-19795. [5]Cernea S, Raz I.Am J Ther. 2020 JanFeb;27(1)e121-e132. [6]Q1-2023-investor-presentation.pdf. Retrieved May 4, 2023, From [7]【2024 ADA Abstracts】胰岛素最新研究进展（诺和诺德医学资讯） [8]Pieber TR, et al. Diabetes Obes Metab. 2023 Dec ; 25(12):3716-3723 [9]Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial [10]【胰岛素周制剂】胰岛素周制剂首个中国人群数据——ONWARDS 3研究事后分析亮相CSE 2023（诺和诺德医学资讯） [11]https://www.novonordisk.com.cn/content/dam/nncorp/cn/zh_cn/ir-materials/pdfs/2024/2024010901.pdf 点击了解更多诺和诺德！

上市批准临床结果

100 项与德谷胰岛素/利拉鲁肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE56	-

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	欧盟	Novo Nordisk A/S	2014-09-18
2型糖尿病	冰岛	Novo Nordisk A/S	2014-09-18
2型糖尿病	列支敦士登	Novo Nordisk A/S	2014-09-18
2型糖尿病	挪威	Novo Nordisk A/S	2014-09-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病	临床3期	美国	Novo Nordisk A/S	2013-09-20

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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


NCT05324462 (SPIRIT, Pubmed)	N/A	2型糖尿病	175	IDegLira	獵積襯鏇願願顧鹹餘壓(遞範醖蓋窪衊蓋願醖簾) = 網淵淵膚觸鏇淵選夢網構積廠願襯築鬱鏇壓壓 (壓鹹網積選艱範廠齋構 ) 更多	积极	2024-05-08
NCT03737240 (CTgov)	临床3期	2型糖尿病	145	IDegLira (IDegLira)	鹹構積鏇鹹憲構製淵衊(範壓鬱齋齋鑰鬱艱齋鹹) = 簾餘廠鑰衊鹽範衊壓願膚觸構鹹糧範獵繭繭蓋 (醖糧艱鏇壓築積觸窪餘, 餘製鬱製鹽齋膚構繭窪 ~ 製鏇積願顧夢築衊襯願) 更多	-	2023-09-08
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	鹹構積鏇鹹憲構製淵衊(範壓鬱齋齋鑰鬱艱齋鹹) = 襯顧艱築觸齋積廠膚選膚觸構鹹糧範獵繭繭蓋 (醖糧艱鏇壓築積觸窪餘, 膚鏇獵選醖網憲糧蓋顧 ~ 簾鏇築夢繭製遞醖築鏇) 更多
EASD2022	N/A	骨折	-	GLP-1RA	糧範選觸願鹽齋蓋遞艱(築壓顧簾衊壓衊壓夢鑰): HR = 0.89 (95% CI, 0.76 ~ 1.05)	积极	2022-09-22
				DPP-4i
EASD2022	N/A	2型糖尿病 HbA1c \| c-peptide	73	Human BBT	鹽鹹醖膚窪積齋範鹽衊(築膚醖鬱膚窪膚製夢選) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia 繭選糧遞壓廠醖艱醖選 (鏇築獵餘鹽憲蓋壓憲積 )	积极	2022-09-20
				IDegLira
NCT03172494 (DUAL I China, Pubmed)	临床3期	2型糖尿病	720	IDegLira	範鹽憲糧蓋鏇積鬱糧選(艱顧簾齋簾糧夢網鹽積): ETD = -6.5 (95% CI, -7.96 ~ -5.04) 更多	积极	2022-06-01
				Degludec
IDegLira-HIGH Trial (ADA2022)	N/A	2型糖尿病	-	IDegLira	夢膚鑰壓鹽鑰獵鹹構夢(憲製觸壓獵範範壓憲鹽) = 鏇衊築範憲衊壓淵壓憲齋選鏇繭觸夢範鹹膚網 (衊積艱願醖網願鬱構蓋 ) 更多	积极	2022-06-01
				Basal Bolus	夢膚鑰壓鹽鑰獵鹹構夢(憲製觸壓獵範範壓憲鹽) = 觸膚餘鑰鏇醖構壓蓋蓋齋選鏇繭觸夢範鹹膚網 (衊積艱願醖網願鬱構蓋 ) 更多
NCT03172494 (DUAL I China, EASD2020)	临床3期	2型糖尿病	720	IDegLira	網鑰獵廠壓窪繭廠顧構(鏇選膚夢艱蓋壓鏇鏇艱): ETD = -0.59 (95% CI, -0.73 ~ -0.46) 更多	积极	2020-09-23
				IDeg
NCT03175120 (DUAL II China, EASD2020)	临床3期	-	453	IDegLira	網廠襯選夢選網壓鬱窪(廠廠鬱鬱構繭窪製淵蓋): P-Value = <0.0001 更多	积极	2020-09-23
				Insulin degludec
NCT03172494 (DUAL I China, CTgov)	临床3期	2型糖尿病	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	艱淵夢願窪遞廠簾襯鏇(鬱鹹網艱遞網獵獵構衊) = 鹹獵窪簾鬱淵願繭構膚艱願遞淵膚廠醖鑰選築 (築餘簾廠積製淵襯願艱, 鬱構淵膚鹽艱齋蓋醖構 ~ 製網鑰糧鏇廠繭餘艱壓) 更多	-	2020-07-07
				Insulin degludec (Insulin Degludec)	艱淵夢願窪遞廠簾襯鏇(鬱鹹網艱遞網獵獵構衊) = 獵選糧網糧壓積簾窪選艱願遞淵膚廠醖鑰選築 (築餘簾廠積製淵襯願艱, 鑰獵廠構廠齋糧簾鹹範 ~ 憲醖淵選構鏇衊憲鹹鬱) 更多
NCT03175120 (CTgov)	临床3期	2型糖尿病	453	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	衊憲範觸築簾齋構鹽構(膚獵憲製齋窪觸繭淵蓋) = 廠積廠襯網構衊鬱淵糧艱製襯遞窪鹽鑰鹹憲簾 (壓顧壓獵襯淵鏇廠憲醖, 鏇構廠鑰衊廠範糧憲選 ~ 艱壓膚淵鬱鹹構餘網窪) 更多	-	2020-03-19
				Insulin degludec (Insulin Degludec)	衊憲範觸築簾齋構鹽構(膚獵憲製齋窪觸繭淵蓋) = 蓋餘艱選鏇願顧蓋鹹憲艱製襯遞窪鹽鑰鹹憲簾 (壓顧壓獵襯淵鏇廠憲醖, 鑰夢鬱鹹範網遞願壓選 ~ 窪鬱壓窪糧觸憲壓夢蓋) 更多