德谷胰岛素/利拉鲁肽(Insulin Degludec / Liraglutide) - 药物靶点：GLP-1R x INSR_在研适应症：2型糖尿病_专利_临床

概要

基本信息

药物类型

激素

别名

IDegLira、Insulin degludec/Liraglutide、Insulin degludec/Victoza

+ [11]

靶点

GLP-1R x INSR

作用方式

激动剂

作用机制

GLP-1R激动剂(胰高血糖素样肽-1激动剂)、INSR激动剂(胰岛素受体激动剂)

治疗领域

内分泌与代谢疾病

在研适应症

2型糖尿病

非在研适应症-

原研机构

Novo Nordisk A/S

在研机构

Novo Nordisk A/SNovo Nordisk, Inc.Novo Nordisk Canada, Inc.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2014-09-18),

2型糖尿病

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

Sequence Code 4857

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Sequence Code 50953

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Sequence Code 91440

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关联

37

项与德谷胰岛素/利拉鲁肽相关的临床试验

NCT06113341

/ WithdrawnN/A

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

ChiCTR2400086382

/ Suspended临床4期IIT

Safety and efficacy of GLP-1RA combined with Banxia Xiexin Decoction in the treatment of type 2 diabetes

开始日期2024-07-15

申办/合作机构-

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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152

项与德谷胰岛素/利拉鲁肽相关的文献（医药）

2025-08-01·DIABETES OBESITY & METABOLISM

What is the ‘real‐world’ experience with fixed‐ratio combination therapy (insulin + GLP‐1 receptor agonist) in routine clinical practice? Take‐home messages for clinicians regarding key outcomes

Review

作者: Frias, Juan Pablo

Abstract:

Aims:

The fixed‐ratio combinations (FRCs) of a basal insulin and glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA), IDegLira (insulin degludec/liraglutide) and iGlarLixi (insulin glargine/lixisenatide), offer a once‐daily injectable treatment option for adults with type 2 diabetes (T2D), combining complementary mechanisms of action to target both fasting and postprandial hyperglycaemia. While randomized controlled trials have demonstrated their efficacy and safety, real‐world evidence (RWE) provides important insights into their effectiveness, tolerability and use across routine clinical practice.

Materials and Methods:

This is a narrative review of selected real‐world studies assessing the FRCs IDegLira and iGlarLixi in adults with T2D. Studies assessing the use of FRCs to intensify and simplify therapy, as well as their use in special populations such as older adults were reviewed and are summarized.

Results:

Among individuals inadequately controlled on oral antihyperglycaemic drugs (OADs), basal insulin ± OADs, or GLP‐1 RAs, initiation of FRC therapy consistently improved glycaemic outcomes, supported modest weight loss or stability, and was associated with a low risk of hypoglycaemia. FRCs have also been evaluated as a strategy for simplifying complex insulin regimens. Transitions from basal–bolus or premixed insulin to FRCs maintained or improved glycaemic control while reducing total daily insulin dose and injection burden.Evidence in special populations and clinical contexts further supports the utility of FRCs. In older adults, FRC use was associated with reductions in HbA1c and hypoglycaemia risk, along with improvements in treatment satisfaction and functional measures. During Ramadan fasting, iGlarLixi demonstrated favourable glycaemic control, low hypoglycaemia incidence, modest weight loss and high adherence. Studies assessing glycaemic control using continuous glucose monitoring showed improvements in time in range, reductions in time above range and stable time below range, indicating enhanced glycaemic stability without increased risk of hypoglycaemia.Two real‐world head‐to‐head studies comparing IDegLira and iGlarLixi found both FRCs to be effective and well tolerated. IDegLira was associated with greater weight loss and lower insulin dose requirements, while iGlarLixi showed advantages in postprandial glucose control. Both agents demonstrated significant improvements in HbA1c and low rates of hypoglycaemia.

Conclusions:

Collectively, these real‐world studies confirm that FRCs are effective, safe and patient‐centred treatment options for adults with T2D. Their simplified dosing, metabolic benefits and favourable safety profiles support their use for both therapy intensification and de‐intensification across a broad spectrum of clinical scenarios. These findings reinforce results from randomized controlled trials, providing further confidence in the role of FRCs in contemporary diabetes care.

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.

2025-05-01·DIABETES RESEARCH AND CLINICAL PRACTICE

The impact of ideglira in treatment simplification in older adults with type 2 diabetes mellitus already on insulin therapy: The stop study

Article

作者: De Fano, Michelantonio ; Fanelli, Carmine G ; Mancinetti, Francesca ; Porcellati, Francesca ; Xenos, Dionysios ; Boccardi, Virginia ; Mazzieri, Alessio

AIM:

The STOP study is a proof-of-concept, aimed at evaluating the effectiveness and safety of IdegLira in deintensifying diabetes therapy in elderly insulin-treated persons with T2DM.

METHODS:

The study was a real world, single center retrospective observation.

RESULTS:

96 persons were enrolled (46F, age 77 ± 7 yrs, HbA1C 7.5 ± 1.0, diabetes duration 21 ± 10 yrs; 75 % in basal/bolus insulin therapy). After 6 months (T6), fasting plasma glucose significantly decreased as compared to T0, as did HbA_1C. The switch to IdegLira was associated with significantly lower rates of level 1 (L1) hypoglycemia at T3 (IR 0.24, 95 % CI 0.11-0.58, p < 0.001) and T6 (IR 0.08, 95 % CI 0.02-0.34, p < 0.001) as compared to T0. Level 2 (L2) hypoglycemia rates significantly decreased at T3 (IR 0.04, 95 % CI 0.01-0.32, p < 0.001) as compared to T0. The proportion of persons (incidence) with L1 hypoglycemia decreased from 33.7 % at T0 to 17.4 % at T3 (p = 0.004) and to 5.8 % at T6 (p < 0.001). Incidence of L2 hypoglycemia decreased from 22.1 % at T0 to 1.16 % at T3 (p < 0.001). No patients had L2 hypoglycemia at T6. Rapid acting insulin was interrupted in 85 % of patients.

CONCLUSIONS:

IdegLira represents a viable option in deintensifying insulin therapy in an elderly population.

47

项与德谷胰岛素/利拉鲁肽相关的新闻（医药）

2025-07-11

·药事纵横

诺和诺德将斥资8亿元在天津新建质检实验室

诺和诺德于周二与天津经济技术开发区（TEDA）签署协议，投资8亿元人民币（约合1.12亿美元）升级其天津生产设施的质检实验室——该基地自1994年投入运营至今。根据TEDA中文新闻稿，新检测设施预计占地约1.8万平方米（约合19.4万平方英尺），涵盖化学、生物学及微生物学实验室。项目预计于2026年底竣工，诺和诺德将启用该设施承担天津工厂的质量控制检测任务。该基地是这家丹麦制药公司全球七大核心生产基地之一。TEDA未披露新实验室将检测的具体药物，但该公司天津基地近期其他项目集中于预填充注射笔生产及无菌药品制造（如诺和泰® Ozempic® 和诺和益® Wegovy®）。信息来源：https://www.fiercepharma.com/manufacturing/novo-keeps-china-manufacturing-investments-rolling-112m-new-quality-testing-lab药事纵横投稿须知：稿费已上调，欢迎投稿

2025-04-22

·药事纵横

每周注射一次！甘李药业 GZR102 注射液获批临床

4月21日，甘李药业自主研发的GZR102注射液获得国家药监局的临床试验批准，作为一款基础胰岛素与胰高糖素样肽-1受体激动剂（GLP-1RA）的固定比例复方周制剂，GZR102的创新性在于将两种不同机制的降糖药物结合，并实现每周一次给药，这在当前糖尿病治疗领域具有显著的技术优势和临床价值。图源：CDE官网GZR102由甘李药业自主研发的超长效胰岛素GZR4和超长效GLP-1RA博凡格鲁肽（GZR18）以固定比例组成。其中，GZR4通过修饰人胰岛素分子形成“循环存储库”，皮下注射后可缓慢释放胰岛素，满足患者一周的基础胰岛素需求；而GZR18作为GLP-1RA，不仅能促进胰岛素分泌、抑制胰高血糖素释放，还能延缓胃排空、增加饱腹感，从而在降糖的同时实现体重控制。这种组合不仅符合国际临床指南推荐的基础胰岛素联合GLP-1RA治疗方案，还通过减少注射频率，从每日一次到每周一次，大幅提升患者依从性，这在糖尿病长期管理中至关重要。据统计，约50%的糖尿病患者因频繁注射而存在治疗依从性问题，导致血糖控制不佳。目前全球已上市的基础胰岛素/GLP-1RA复方制剂均为日制剂，例如诺和诺德的Xultophy（德谷胰岛素/利拉鲁肽）和赛诺菲的Soliqua（甘精胰岛素/利司那肽）。而GZR102作为首款进入临床阶段的周制剂复方药物，若能成功上市，将填补这一领域的技术空白，并为2型糖尿病患者提供更便捷的治疗选择。近年来，GLP-1类药物因显著的降糖和减重效果成为医药研发的热门赛道。根据统计，全球在研的GLP-1类药物已超过100款，其中诺和诺德的司美格鲁肽（Semaglutide）和礼来的替尔泊肽（Tirzepatide）占据主导地位。司美格鲁肽2023年全球销售额突破200亿美元，而替尔泊肽凭借双靶点（GLP-1/GIP）机制在减重效果上更具优势。甘李药业的GZR18作为对标司美格鲁肽的单靶点GLP-1RA，已在中国进入III期临床，并在美国开展针对肥胖适应症的II期试验，其减重疗效甚至计划与替尔泊肽进行头对头比较。GZR102的复方设计进一步拓展了GLP-1类药物的应用场景。一方面，基础胰岛素与GLP-1RA的联合可协同改善血糖控制，减少低血糖风险；另一方面，GZR18的减重特性能够抵消胰岛素治疗可能导致的体重增加副作用。根据甘李药业的早期临床试验数据，GZR102在降低糖化血红蛋白（HbA1c）和体重控制方面均优于单一组分。这种优势在糖尿病合并肥胖患者中尤为重要，我国成人糖尿病患病率达11.9%，其中超重或肥胖人群占比超过65%。从市场前景看，中国GLP-1类药物市场规模预计到2030年将超过600亿元，而复方制剂因其综合疗效可能占据更大份额。若GZR102能率先上市，甘李药业不仅能在国内市场打破外资垄断，还可依托其国际化布局（如GZR18的美国临床进展）参与全球竞争。尽管GZR102的前景光明，但其研发仍面临多重挑战。首先，复方制剂的药代动力学复杂性较高，需确保两种成分的释放速率和血药浓度曲线匹配。例如，GZR4的超长效特性依赖于与白蛋白的可逆结合，而GZR18作为两周给药一次的GLP-1RA，如何在复方中调整为周制剂并维持疗效，需要精细的剂型设计。其次，III期临床试验的规模和时长可能成为资金与时间的考验。截至2024年9月，GZR102项目的累计研发投入仅1507万元，而单方GZR4和GZR18的III期临床仍在进行中，复方制剂的后续开发成本或将大幅增加。此外，市场竞争的激烈程度不容小觑。除了外资企业的先发优势，国内药企如信达生物、恒瑞医药等也在加速布局GLP-1领域。例如，信达生物的玛仕度肽（IBI362）已进入III期临床，其双靶点设计（GLP-1/GCGR）在减重效果上表现突出。若这些竞品率先获批，可能挤压GZR102的市场空间。长期以来，国内药企在生物类似药和fast-follow药物上表现活跃，但在真正意义上的首创新药（First-in-Class）上成果有限。甘李药业通过GZR4和GZR18的自主研发，展示了在长效化技术上的积累，这为后续开发其他复方或新靶点药物奠定了基础。从更宏观的视角看，GZR102的成功可能推动糖尿病治疗模式的转变。当前，临床指南倾向于阶梯式治疗，如从口服药到胰岛素，而复方制剂有望通过更早的联合治疗实现血糖的快速稳定，减少并发症风险。此外，周制剂的便利性可能吸引更多潜在患者，如工作繁忙的年轻人群，接受规范治疗，从而改善整体疾病管理效率。不过，医药创新始终伴随高风险。GZR102从临床试验到最终上市仍需数年时间，且疗效与安全性需在更大样本中得到验证。投资者需关注甘李药业的研发管线推进效率及资金链稳定性，而患者则期待这一创新疗法能真正兑现“减少注射痛苦，提升生活质量”的承诺。信息来源：CDE官网、中国糖尿病防治指南（2024版）药事纵横投稿须知：稿费已上调，欢迎投稿

临床3期临床2期临床成功

2025-04-22

·ETPharma

Novo Nordisk to phase out its largest insulin brand in India

New Delhi: In a move which could shake up the diabetes market, Novo Nordisk is discontinuing the country’s largest selling insulin, Human Mixtard , among other older insulin brands in India. Human Mixtard alone is a Rs 800 crore brand for Novo Nordisk in India, despite it being under price control. Besides Human Mixtard, the phase-out could impact its top brands in the Rs 5,000 crore insulin market including Actrapid, Insulatard, Insulin Detemir and Levemir and Xultophy — marketed mostly in the format of pre-filled disposable pen and cartridges (Penfill and FlexPen). The company recently informed its marketing partner, Abbott India that the products would be discontinued once the current stocks are exhausted, documents accessed by TOI said. This could take about six months. The decision is in line with the global strategy of the Danish company to prioritise newer, patented blockbuster diabetes and weight loss therapies including Ozempic and Wegovy , due to their higher profitability, sources said. Also, it seems to be potentially in line with its plans to introduce these therapies in the Indian market this year. As part of its global strategy, earlier generation insulin products will be discontinued globally in a gradual manner. An email sent on April 17 to the company went unanswered. However, the company plans to continue selling Human Mixtard, Actrapid and Insulatard, in vials — which can be delivered to patients through injections. This may limit the access further as insulin delivery from pen devices is preferred by a huge majority of diabetics over vials injected with syringes, due to its accuracy, ease of dosing, and reduced stigma, a survey said earlier. By Rupali Mukherjee ,

并购上市批准

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
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研发状态

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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

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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1期	德国	Novo Nordisk A/S	2009-09-01

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适应症

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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	鏇遞夢壓鏇網鏇衊網顧(襯壓鹹鑰膚遞網選鬱觸) = 觸鑰醖廠鹽蓋膚製鹹積網壓衊壓膚網鑰觸觸鹹 (獵蓋淵艱製鹽積簾築獵, - 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)	蓋餘獵膚窪鏇鏇構淵餘(願簾選觸衊繭鑰鬱窪憲) = 選憲鑰構築襯選壓繭餘願鏇顧艱壓範遞顧蓋網 (願醖淵顧積鑰鏇選醖觸, 2.29) 更多	-	2023-09-08
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	蓋餘獵膚窪鏇鏇構淵餘(願簾選觸衊繭鑰鬱窪憲) = 蓋餘壓築願遞鑰築積觸願鏇顧艱壓範遞顧蓋網 (願醖淵顧積鑰鏇選醖觸, 1.79) 更多
EASD2022	N/A	2型糖尿病 HbA1c \| c-peptide	73	Human BBT	積憲積衊鹽醖廠鏇廠鹹(積艱蓋膚壓構製夢鹹範) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia 簾淵獵範壓夢壓醖鬱構 (鏇獵夢鹽壓積衊鏇選顧 )	积极	2022-09-20
				IDegLira
NCT03172494 (DUAL I China, EASD2020)	临床3期	2型糖尿病	720	IDegLira	壓遞獵憲齋網遞繭鑰憲(網壓鑰鏇蓋鹹餘簾鏇製): 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	2型糖尿病	453	IDegLira	積糧願襯鬱鏇範壓壓構(遞鹽觸獵鹽廠餘築廠鬱): P-Value = <0.0001 更多	积极	2020-09-23
				Insulin degludec
NCT03172494 (DUAL I China \| DUAL™ I China, CTgov)	临床3期	2型糖尿病	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	齋積憲獵蓋窪鑰壓廠選(選膚遞網鬱願衊鑰遞憲) = 憲廠築構窪製構襯淵齋蓋壓窪網蓋窪顧艱廠鬱 (網網鑰壓遞糧築壓遞齋, 0.88) 更多	-	2020-07-07
				Insulin Degludec (Insulin Degludec)	齋積憲獵蓋窪鑰壓廠選(選膚遞網鬱願衊鑰遞憲) = 鬱齋鏇鑰醖網積選憲艱蓋壓窪網蓋窪顧艱廠鬱 (網網鑰壓遞糧築壓遞齋, 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)	構積鬱艱繭積築獵顧積(夢網窪膚襯壓鹽鹹鹽簾) = 齋簾願築襯網衊糧醖餘廠憲網簾蓋獵艱齋廠窪 (願艱鑰構鏇淵網膚憲膚, 1.14) 更多	-	2020-03-19
				Insulin Degludec (Insulin Degludec)	構積鬱艱繭積築獵顧積(夢網窪膚襯壓鹽鹹鹽簾) = 鹽鏇糧蓋願夢餘鑰範積廠憲網簾蓋獵艱齋廠窪 (願艱鑰構鏇淵網膚憲膚, 1.19) 更多
NCT02420262 \| NCT01952145 (Pubmed \| Diabet Med)	临床3期	2型糖尿病	-	Insulin degludec/liraglutide (IDegLira)	網獵餘範蓋繭願憲獵蓋(選獵積簾廠鏇顧繭製餘) = 蓋醖醖遞襯壓範襯餘醖夢鑰憲廠鹹窪膚範壓壓 (觸顧齋積鹹築蓋壓鏇願 ) 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	襯齋獵鏇鑰獵鹽觸獵選(鹹淵憲築夢簾鬱遞範憲): ETD = -13.98 (95% CI, -16.41 ~ -11.55), P-Value = <0.0001 更多	优效	2019-12-01
				metformin+degludec
NCT02501161 (DUAL™ VIII \| DUAL Ⅷ \| DUAL VIII, CTgov)	临床3期	2型糖尿病	1,012	Insulin Degludec+Liraglutide (Insulin Degludec/Liraglutide)	積積蓋夢觸遞鬱齋構廠(鹽網鬱餘餘蓋鬱糧範憲) = 齋醖範壓繭齋蓋憲壓積衊鹹遞鏇餘鏇壓遞鹹衊 (壓鬱繭艱積網齋衊獵顧, 積製鏇餘鏇壓選醖願範 ~ 膚鹽壓鑰願廠鹹壓蓋網) 更多	-	2019-11-27
				Insulin Glargine (Insulin Glargine)	積積蓋夢觸遞鬱齋構廠(鹽網鬱餘餘蓋鬱糧範憲) = 願蓋窪膚窪網觸鑰憲願衊鹹遞鏇餘鏇壓遞鹹衊 (壓鬱繭艱積網齋衊獵顧, 繭築顧觸糧醖鹹鏇獵顧 ~ 蓋積鹹觸鹹選鑰壓衊獵) 更多