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2024-11-07

申办/合作机构

Novo Nordisk A/S

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

JPRN-UMIN000052156

/ RecruitingN/AIIT

Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels - Conparison of IDegLira vs IDeg in multiple daily injection therapy

开始日期2023-09-05

申办/合作机构-

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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项与德谷胰岛素/利拉鲁肽相关的文献（医药）

2025-09-11·CURRENT DIABETES REVIEWS

Efficacy and Safety of IDegLira in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Article

作者: Liu, Delong ; Yang, Zhiyong ; Su, Ning ; Zhang, Lina ; Bai, Lexie

Introduction::

Clinical trials indicate that IDegLira is effective in treating type 2 diabetes mellitus (T2DM). This study aims to assess the efficacy and safety of IDegLira in type 2 diabetes mellitus (T2DM) comprehensively.

Methods::

To identify relevant randomized controlled trials, we searched PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov. Risk Ratios (RR) and 95% Confidence Intervals (CI) were calculated using the Mantel-Haenszel approach for dichotomous outcomes. Mean Difference (MD) and 95% CI calculated by the inverse variance approach were applied to continuous outcomes.

Results::

Twelve randomized controlled trials involving 7628 participants were included in this study. Compared with control groups, IDegLira has a significant hypoglycemic effect in reducing hemoglobin A1c (MD = −0.66; 95% CI [−0.85, −0.47]; p < 0.00001), fasting plasma glucose (MD = −0.90; 95% CI [−1.40, −0.41]; p = 0.0003), self-measured plasma glucose (MD = −0.82; 95% CI [−1.22, −0.42]; p < 0.0001) and achieving the hemoglobin A1c level of < 7.0%(RR = 1.66; 95% CI [1.44, 1.92]; p < 0.00001) or < 6.5% (RR = 2.13; 95% CI [1.76, 2.57]; p < 0.00001). IDegLira outperforms insulin in achieving the target of HbA1c < 7.0 or < 6.5% without hypoglycemia and weight gain. Besides, IDegLira did not increase the incidence of adverse events and serious adverse events.

Discussion::

In this section, IDegLira's benefits on simultaneously achieving glycemic control, weight loss, and reduced hypoglycemia risk were summarized. The statistical results were carefully interpreted in conjunction with clinical concerns regarding T2DM complications, adverse effects, and cost-effectiveness differences. An expanded discussion was conducted on integrating individualized HbA1c goals as a dual endpoint, without increasing body weight or the risk of hypoglycemia. Finally, the limitations of the present study are indicated.

Conclusions::

IDegLira exhibits a favorable glycemic control effect and acceptable adverse effects in Type 2 Diabetes Mellitus (T2DM). Superior performance in the target glycemic control, particularly suitable for T2DM patients who do not reach the target hemoglobin A1c and have comorbid CVD or obesity.

2025-09-01·DIABETOLOGIA

Insulin DEgludec/LIraglutide versus multiple daily insulin injections in the transition from hospital to outpatient management assessed by continuous glucose monitoring: the DELI transition trial

Article

作者: Gómez-Medina, Ana M ; Pertuz-Noriega, Carlos E ; Gómez-Quesada, Yaline ; Villamil-Castañeda, Lina P ; Muñoz-Velandia, Oscar M ; Chaim, Salma N ; Aschner, Pablo ; Yepes, Carlos A ; Henao-Carillo, Diana C

Abstract:

Aims/objective:

The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels <3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting.

Methods:

The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8–10 mmol/l), the time below range (TBR <3.0 or <3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring.

Results:

Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA1c of 103 ± 11.6 mmol/mol (11.6 ± 1.7%) and age of 58 ± 12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose <3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; p<0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; p<0.001), TBR <3.8 mmol/l (0.9% vs 2.9%; p=0.019) and TBR <3.0 mmol/l (0.6% vs 1.3%, p=0.008). The TIR 3.8–10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; p=0.008). The findings were consistent regardless of baseline HbA1c.

Conclusions/interpretation:

IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care.

Trial registration:

Clinicaltrials.gov NCT05767255

Funding:

This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).

Graphical Abstract:

2025-08-01·DIABETES OBESITY & METABOLISM

An overview of randomized clinical trials of fixed‐ratio combinations of basal insulin plus GLP ‐ 1RA (injectable therapy): Lessons for advancing therapy in people with type 2 diabetes

Review

作者: Fanelli, Carmine G. ; Porcellati, Francesca ; Bolli, Geremia B. ; Horowitz, Michael ; Perseghin, Gianluca ; Owens, David R. ; Lucidi, Paola

Abstract:

Advancing therapy in T2DM with injectables, i.e., basal insulin (BI) and GLP‐1 receptor agonists (GLP‐1RAs) is recommended after the failure of oral glucose lowering agents (OGLAs), BI alone, or BI in combination with OGLAs, especially in persons with, or at high risk of atherosclerotic cardiovascular disease (ASCVD). BI and GLP‐1RAs can be administered separately or as fixed‐ratio combinations (FRCs) for daily use (degludec+liraglutide, IDegLira, glargine‐100 + lixisenatide iGlarLixi) or weekly use (icodec+semaglutide, IcoSema). The currently available FRCs IDegLira and iGlarLixi differ in their respective BI as well as GLP‐1RA components. Liraglutide predominantly stimulates glucose‐dependent endogenous insulin secretion in response to nutrient challenges. In contrast, the rapid‐acting lixisenatide primarily delays gastric emptying over a few hours post‐dosing with little or no impact on insulin secretion. IDegLira in DUAL studies and iGlarLixi in LixiLan studies appear to have equivalent lowering effects on HbA1c, although IDegLira achieves a greater reduction in body weight. The weekly FRC IcoSema is superior to weekly insulin icodec (COMBINE 1), to semaglutide (COMBINE 2), and non‐inferior to basal‐bolus insulin therapy (COMBINE 3). Comparison of IcoSema with glargine‐100 is ongoing (COMBINE 4). However, all FRCs are limited by the low GLP‐1RA dose relative to the insulin delivered. Whenever higher GLP‐1RA doses are required (i.e., in obese people), the option of separate dosing of BI and GLP‐1RA with independent titration of each component should be considered.

项与德谷胰岛素/利拉鲁肽相关的新闻（医药）

2025-12-01

·国际糖尿病idiabetes

德谷胰岛素利拉鲁肽中国真实世界研究更多新数据于CDS 2025公布

2025年11月19~22日，中华医学会糖尿病学分会（CDS）第二十七次学术会议在陕西西安隆重举办。会议期间公布了德谷胰岛素利拉鲁肽中国真实世界研究两项新的亚组分析结果，为这种创新联合制剂在中国2型糖尿病（T2DM）患者中的应用提供了更多数据支持，对于指导临床实践具有重要意义。这项大规模中国真实世界研究的主要研究者是天津医科大学朱宪彝纪念医院的陈莉明教授，主要结果已于2025年9月在欧洲糖尿病研究协会（EASD）年会上首次公布，引发广泛关注，此次CDS会议新数据亦备受瞩目。为帮助临床医生更好地了解德谷胰岛素利拉鲁肽在真实临床情境中的实际应用效果，本刊特邀天津医科大学朱宪彝纪念医院的陈莉明教授和孙蓓教授进行访谈，深度解读研究数据。一整体研究概览：德谷胰岛素利拉鲁肽显著改善中国T2DM患者血糖控制《国际糖尿病》请您介绍一下这项中国真实世界研究的总体情况？陈莉明教授：德谷胰岛素利拉鲁肽是德谷胰岛素与利拉鲁肽的固定比例复方制剂，用于成人T2DM的治疗[1]。3期临床研究结果已证实德谷胰岛素与利拉鲁肽在T2DM患者中的疗效和安全性，显示出增强降糖疗效的同时减少不良反应。国际上的真实世界研究也进一步印证了这种创新联合制剂在临床实践中的疗效和安全性[2]。然而，目前关于德谷胰岛素利拉鲁肽在中国真实临床中实际应用效果的研究有限。因此，这是本研究提出的核心问题，也是临床关注的焦点。德谷胰岛素利拉鲁肽中国真实世界研究是一项利用区域性电子健康档案进行的回顾性、单臂、队列研究，纳入2022年3月~2024年6月处方德谷胰岛素利拉鲁肽治疗的12,103例成人T2DM患者，分析德谷胰岛素利拉鲁肽持续治疗180天后各项临床指标相较基线的变化[3]。主要研究终点为糖化血红蛋白（HbA1c）的变化，次要研究终点为空腹血糖（FPG）、餐后血糖（PPG）及胰岛素日剂量的变化，并按基线时的治疗方案、HbA1c水平及胰岛素日剂量进行亚组分析，探索不同亚组HbA1c的变化。研究结果显示，在主要研究终点上，在接受德谷胰岛素利拉鲁肽持续治疗的1159例患者中，第180天时，患者HbA1c水平从基线8.45%降至7.38%，降幅达1.08%（P<0.001）；HbA1c<7%的患者比例从基线17.3%显著增至41.2%（P<0.001，图1）。在次要终点上，治疗180天时，患者FPG从基线9.90 mmol/L显著降至7.56 mmol/L，降幅为2.34 mmol/L（P<0.001）；PPG从基线11.91 mmol/L显著降至9.81 mmol/L，降幅为2.10 mmol/L（P<0.001）；胰岛素日剂量从34.54 U/d显著降至29.63 U/d，减少4.95 U/d（P<0.001）。图1. 德谷胰岛素利拉鲁肽显著降低HbA1c，提高HbA1c达标率亚组分析显示，无论患者既往治疗方案如何，包括仅使用口服降糖药、基础胰岛素、预混胰岛素、基础-餐时胰岛素、GLP-1RA的患者，各亚组患者治疗后HbA1c均显著下降（P<0.001）。无论胰岛素用量如何，按照基线胰岛素剂量<20 U/d、20~30 U/d、30~40 U/d以及>40 U/d进行分层分析，各亚组患者治疗后HbA1c均显著下降（P<0.001）。而且，基线HbA1c水平越高，HbA1c降幅越大（趋势P<0.001）。《国际糖尿病》基于上述整体研究的结果，请您谈谈这项研究的意义？陈莉明教授：该研究纳入较大样本（12,103例）的成人T2DM患者，广泛评估了德谷胰岛素利拉鲁肽在实际临床中的血糖控制情况，并且评估了多维度的临床指标，同时进行了具有临床意义的亚组分析，这对于指导临床实践具有重要意义。二亚组分析新数据：德谷胰岛素利拉鲁肽满足中国T2DM患者个体化治疗需求《国际糖尿病》本届CDS会议上公布了一项亚组分析，针对既往接受基础胰岛素治疗的T2DM患者，评估其转换为德谷胰岛素利拉鲁肽治疗后的血糖控制情况。请您介绍一下这项亚组分析的结果？孙蓓教授：这项亚组分析旨在评估既往基础胰岛素日制剂治疗转换为德谷胰岛素利拉鲁肽治疗的T2DM患者，第180天HbA1c相较于基线的变化[4]。共纳入224例既往基础胰岛素治疗转换为德谷胰岛素利拉鲁肽治疗的T2DM患者，其中，转换自甘精胰岛素U300、甘精胰岛素U100、德谷胰岛素和地特胰岛素的患者分别为89例、78例、15例和16例。结果显示，在既往接受基础胰岛素治疗的整体人群中，转换为德谷胰岛素利拉鲁肽治疗180天后，HbA1c从基线的8.17%显著降至第180天的7.45%，降幅为0.72%（P<0.001）。其中，甘精胰岛素U300亚组中，HbA1c从基线的8.19%显著降至第180天的7.37%，降幅为0.82%（P<0.001，图2）；甘精胰岛素U100亚组中，HbA1c从基线的8.09%显著降至180天的7.35%，降幅为0.74%（P<0.001，图2）；由于样本量不足，德谷胰岛素组和地特胰岛素组未能进行统计学分析。该亚组分析结果显示，在真实世界中，既往接受基础胰岛素治疗的中国成人T2DM患者，转换为德谷胰岛素利拉鲁肽治疗可以显著改善血糖控制。图2. 甘精胰岛素U300/U100转换为德谷胰岛素利拉鲁肽治疗，HbA1c显著降低《国际糖尿病》本届CDS会议上还公布了另一项亚组分析，基于基线C肽水平评估德谷胰岛素利拉鲁肽治疗T2DM患者的血糖控制情况。请您介绍一下这项亚组分析的结果？孙蓓教授：这项亚组分析旨在探讨基于不同基线空腹C肽水平德谷胰岛素利拉鲁肽治疗T2DM患者的HbA1c控制情况[5]。本分析纳入了307例具有基线C肽记录的患者，平均基线C肽水平为0.74 nmol/L，基于基线C肽的四分位数分为4个亚组，分别为Q1组（< 0.45 nmol/L，n=78）、Q2组（0.45~0.67 nmol/L，n=75）、Q3组（0.67~0.97 nmol/L，n=78）及Q4组（≥0.97 nmol/L，n=76）。评估不同亚组HbA1c从基线到第180天的变化。结果显示，各亚组的HbA1c在180天后均较基线显著下降，降幅分别为-1.25%、-1.49%、-1.60%、-1.31%（所有亚组均P<0.001，图3）。各组间HbA1c降幅差异无统计学意义（P=0.747，图3）。该结果证实，在真实世界临床实践中，德谷胰岛素利拉鲁肽治疗中国T2DM患者可显著改善血糖控制，在不同基线C肽亚组中HbA1c均显著下降，且HbA1c降幅不受患者基线C肽水平影响。图3. 基线不同C肽水平的T2DM患者，德谷胰岛素利拉鲁肽治疗HbA1c均显著降低《国际糖尿病》结合“德谷胰岛素利拉鲁肽中国真实世界研究”的主要结果及其两项新的亚组分析结果，请您谈谈这对于临床实践有哪些重要启示？孙蓓教授：该研究结果补充了德谷胰岛素利拉鲁肽中国真实世界数据，对于指导临床实践具有重要意义。结果显示，在中国真实临床实践中，德谷胰岛素利拉鲁肽能够显著降低HbA1c、FPG及PPG水平，提高HbA1c达标率，同时减少胰岛素用量。这体现出德谷胰岛素利拉鲁肽作为基础胰岛素和GLP-1RA联合制剂的优势，在机制上覆盖T2DM的多重发病机制，在临床效果上增强降糖疗效并减少不良反应。这项研究进行了多项具有临床意义的亚组分析，为临床医生提供了重要参考。按既往使用的基础胰岛素的亚组分析：从基础胰岛素（包括甘精胰岛素U300和U100）转换为德谷胰岛素利拉鲁肽治疗，HbA1c显著下降，血糖进一步改善。按基线空腹C肽的亚组分析：在不同基线C肽亚组中，HbA1c均显著下降，且德谷胰岛素利拉鲁肽改善血糖控制不受基线C肽水平的影响，这为临床实践提供了有价值的参考。按基线HbA1c水平的亚组分析：各组HbA1c均显著下降，且基线HbA1c水平越高，降幅越大，其中HbA1c>10%人群中HbA1c降幅达3.46%，表明对于基线HbA1c水平较高的T2DM患者，德谷胰岛素利拉鲁肽同样可以带来获益。按照既往降糖治疗方案的亚组分析：既往仅使用口服降糖药、基础胰岛素、预混胰岛素、基础-餐时胰岛素、GLP-1RA的患者，转换为德谷胰岛素利拉鲁肽治疗后，血糖控制均得到改善，表明既往治疗方案血糖控制不佳的患者，可考虑转换为德谷胰岛素利拉鲁肽治疗以改善血糖控制。三结语德谷胰岛素利拉鲁肽中国真实世界研究的主要结果及其亚组分析，补充了该创新联合制剂在中国的真实世界证据，进一步丰富并完善了其循证证据体系。其结果充分验证了德谷胰岛素利拉鲁肽可显著改善中国T2DM患者的血糖控制，满足不同临床特征患者的个体化治疗需求，为临床实践提供重要参考。参考文献（上下滑动可查看） 1. Bolli GB, et al. Diabetes Obes Metab. 2025; 27 Suppl 7(Suppl 7): 14-25. 2. Frias JP. Diabetes Obes Metab. 2025; 27 Suppl 7(Suppl 7): 26-41. 3. Liming Chen. Improved glycaemic control with IDegLira in Chinese adults with type 2 diabetes in a real-world setting: a retrospective cohort study. Short Oral presented at EASD 2025. PRESENTATION ID 927. 4. 王珊珊, 等. 既往基础胰岛素治疗转换为德谷胰岛素利拉鲁肽治疗的2型糖尿病患者血糖控制情况. 中华医学会糖尿病学分会第二十七次学术会议 (CDS2025). 5. 孙蓓, 等. 基于基线C肽水平评估德谷胰岛素利拉鲁肽治疗2型糖尿病患者的血糖控制情况：一项中国真实世界回顾性研究的亚组分析. 中华医学会糖尿病学分会第二十七次学术会议 (CDS2025). 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果临床3期

2025-11-22

·百度百家

诺和益：糖尿病治疗的历史突破与未来展望

在1874年，古埃及学家埃伯斯（Georg Ebers）发现了一本记载于纸莎草上的古埃及医书。经过考证，该书创作于公元前1500年前后。书中，古埃及医生们描述了一种“ 多饮多尿”的病症，并详细记录了利用谷物、水果和甜酒进行治疗的方法。这一发现揭示了糖尿病的古老历史。历经三千多年的探索，人类与糖尿病的斗争始终未能取得决定性胜利。直至近百年，随着医学的重大突破，糖尿病才逐渐从“ 不治之症”转变为可治的慢性疾病。目前，人类已开发出近10大类治疗糖尿病的药物，但糖尿病仍未被彻底根治，其危害依然存在。 ▲ 现代糖尿病治疗发展随着医学的进步，糖尿病治疗需求依然巨大。以胰岛素为例，尽管其已走过百年历程，依然稳坐对抗糖尿病的主战场。胰岛素的发现为糖尿病患者的预后带来了显著改变。然而，这并非根治方法，而是为患者提供了更稳定的治疗选择。早期的胰岛素来源于牛和猪，但因纯度问题，常引发过敏反应。随着第一代胰岛素制剂的出现，其局限性也逐渐显现，如作用时间短，导致患者需频繁注射。尽管胰岛素治疗在过去的百年中取得了显著进展，但目前仍无法完全模拟正常胰岛素分泌模式。 ▲ 胰岛素的历史与现状为了更接近生理性胰岛素分泌，胰岛素治疗通常包括基础胰岛素替代和餐时或短效胰岛素替代两部分。下一代胰岛素的发展目标是缩小与正常胰岛素分泌模式的差距。21世纪初，德谷胰岛素这一创新药物终于问世。德谷胰岛素的42小时持久作用，让“注射几秒，控糖一整天”成为可能，但其研发之路充满挑战。 ▲ 糖尿病治疗的挑战糖尿病治疗药物的长期安全性和依从性仍是一个难题。由于2型糖尿病的发病机制涉及全身多个组织器官，单一靶点的药物往往难以长期保持疗效和安全性。皮下注射作为某些糖尿病药物的主要给药途径，相较于口服药物，其使用并不那么便捷。对于初次尝试的患者来说，长时间的注射过程往往需要克服心理障碍，进而影响血糖的控制。针对这一挑战，创新性的药物研发成为了关键。 ▲ 诺和益的创新诺和益（德谷胰岛素利拉鲁肽注射液）的推出，为糖尿病患者带来了更多的治疗选择。诺和益结合德谷胰岛素与利拉鲁肽，不仅作用机制独特，更代表着“多靶点”治疗的新方向。其创新的双组分设计能够更全面地调节血糖水平，直击T2DM发病机制的本源。这种药物的上市标志着糖尿病治疗的新进展，改善了胰岛素抵抗和β细胞功能障碍，为患者带来了更好的治疗效果。 ▲ 诺和益的研发历程与上市意义 2022年3月5日，诺和诺德公司迎来了一个重大里程碑，其研发的全球首个基础胰岛素GLP-1RA注射液—— 诺和益，正式在中国上市。这个突破不仅为糖尿病治疗提供了新的选择，也标志着糖尿病治疗的新进展。 ▲ 诺和益的临床研究证据在 DUAL项目中，经过8年努力，9项研究验证了诺和益的安全性和有效性。对于血糖控制不佳的T2DM患者，无论之前接受何种治疗，联合或转换为德谷胰岛素利拉鲁肽注射液后，均展现出一致的临床有效性和安全性。这一系列研究不仅进一步验证了诺和益治疗的优点，同时也为医生提供了有力的用药参考。 ▲ 诺和益的市场与社会责任诺和诺德积极应对未满足的市场需求，承担社会责任。据张克洲博士透露，诺和诺德目前致力于研发“周制剂”胰岛素，该药物一旦完成全球临床试验并获得批准，将进一步巩固公司在糖尿病治疗领域的地位。此外，诺和诺德积极与“周制剂”GLP-1RA司格美鲁肽的联合应用进行探索。 ▲ 诺和诺德的研发策略与创新诺和诺德以其稳健的步伐在研发领域保持创新。为了促进合作与科研成果转化，公司创立了开放创新平台INNOVO。该平台已取得显著进展，涵盖了20余个项目，不仅推动了糖尿病、肥胖症等领域的发展，还促进了非酒精性脂肪性肝炎以及人工智能辅助的新药研发等前沿领域的探索。 ▲ 诺和诺德在中国市场的前景面对中国糖尿病患者群体的大幅增加及治疗需求，诺和诺德凭借强大的研发与创新能力，将继续领先糖尿病治疗领域。在中国市场，诺和诺德不仅提供创新的糖尿病治疗方案，还积极承担社会责任，为患者的健康管理提供支持与贡献。展望未来，诺和诺德将继续推动行业变革，为患者带来更好的治疗选择和希望。

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

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,

后查看更多信息

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,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
糖尿病	临床1期	德国	Novo Nordisk A/S	2009-09-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05324462 (SPIRIT, Pubmed) 人工标引	N/A	2型糖尿病	175	IDegLira	遞網鬱夢鏇製膚鹹衊製(鑰鹽鹽淵夢艱窪壓顧網) = 鑰壓憲餘蓋憲網鏇壓顧鹽糧廠顧壓積鬱顧獵淵 (築鏇鏇鏇範築餘鬱選鬱, - 1.6 ~ - 1.0) 更多	积极	2024-05-08
NCT03737240 (CTgov)	临床3期	2型糖尿病	145	IDegLira (IDegLira)	顧願淵遞膚鹽夢窪窪築(齋鹽齋糧鏇顧網醖淵淵) = 艱網積蓋鏇選獵餘製觸壓齋膚簾壓鏇繭艱積襯 (蓋選觸淵鑰築積襯衊觸, 2.29) 更多	-	2023-09-08
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	顧願淵遞膚鹽夢窪窪築(齋鹽齋糧鏇顧網醖淵淵) = 鹽餘簾網壓鬱醖餘選顧壓齋膚簾壓鏇繭艱積襯 (蓋選觸淵鑰築積襯衊觸, 1.79) 更多
EASD2022	N/A	2型糖尿病 HbA1c \| c-peptide	73	Human BBT	鬱蓋製膚構餘憲襯鑰鹽(齋廠築蓋鬱獵憲願廠衊) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia 淵鏇艱願繭繭構獵憲鏇 (選夢遞醖鏇餘餘鏇製簾 )	积极	2022-09-20
				IDegLira
DUAL I China (Pubmed \| J Diabetes)	临床3期	2型糖尿病	-	IDegLira	衊夢願構餘選艱壓鬱廠(淵鹽鹽衊築醖壓獵衊簾): ETD = -6.5 (95% CI, -7.96 ~ -5.04) 更多	积极	2022-06-01
				Degludec
NCT03175120 (DUAL II China, EASD2020)	临床3期	2型糖尿病	453	IDegLira	觸襯鬱顧鹽醖壓築廠遞(醖窪製蓋築壓簾鏇膚簾): P-Value = <0.0001 更多	积极	2020-09-23
				Insulin degludec
NCT03172494 (DUAL I China, EASD2020)	临床3期	2型糖尿病	720	IDegLira	蓋範獵窪繭觸壓繭淵顧(積鏇衊遞築醖襯構壓鹽): ETD = -0.59 (95% CI, -0.73 ~ -0.46) 更多	积极	2020-09-23
				IDeg
NCT03172494 (DUAL I China \| DUAL™ I China, CTgov)	临床3期	2型糖尿病	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	願糧齋獵觸願鏇廠遞窪(築鑰淵構衊鹹獵鹹選鏇) = 繭觸齋憲簾膚蓋憲憲淵積鹹網築範憲獵鹹網鏇 (蓋繭繭繭簾構蓋簾淵選, 0.88) 更多	-	2020-07-07
				Insulin Degludec (Insulin Degludec)	願糧齋獵觸願鏇廠遞窪(築鑰淵構衊鹹獵鹹選鏇) = 憲積鏇壓窪憲窪齋膚衊積鹹網築範憲獵鹹網鏇 (蓋繭繭繭簾構蓋簾淵選, 0.99) 更多
NCT03175120 (DUAL™ II China \| DUAL II China, CTgov)	临床3期	2型糖尿病	453	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	憲範願淵範鹽遞齋築淵(網構艱艱淵齋糧襯襯鬱) = 鏇製選淵衊齋選鹽選艱膚網範衊齋鹽鏇築壓鏇 (積鹹鬱壓蓋膚顧構醖觸, 1.14) 更多	-	2020-03-19
				Insulin Degludec (Insulin Degludec)	憲範願淵範鹽遞齋築淵(網構艱艱淵齋糧襯襯鬱) = 選鏇膚鏇願鹽繭衊襯網膚網範衊齋鹽鏇築壓鏇 (積鹹鬱壓蓋膚顧構醖觸, 1.19) 更多
NCT02420262 \| NCT01952145 (Pubmed \| Diabet Med)	临床3期	2型糖尿病	-	Insulin degludec/liraglutide (IDegLira)	構構膚製鏇繭選餘艱選(繭襯鏇獵夢鬱構選蓋願) = 衊膚願鑰構鹽蓋襯簾積醖鑰繭鏇簾壓獵範壓簾 (鹹鹹鑰積艱繭顧遞蓋鏇 ) 更多	-	2020-02-01
NCT02911948 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	210	metformin+degludec/liraglutide	鑰窪衊膚膚獵憲夢衊築(餘鏇壓壓積簾壓顧鹹觸): ETD = -13.98 (95% CI, -16.41 ~ -11.55), P-Value = <0.0001 更多	优效	2019-12-01
				metformin+degludec