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）

2026-06-01·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

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.

项与德谷胰岛素/利拉鲁肽相关的新闻（医药）

2026-04-02

·米内网

糖尿病药王遭“围攻”！2大超10亿品牌领跑，扬子江、甘李上榜，恒瑞、君圣泰1类新药来袭

精彩内容近期，糖尿病用药（化+生，下同）新品捷报频传。北京双鹭药业的西格列汀二甲双胍片(Ⅰ)/(Ⅱ)、正大天晴药业集团的恩格列净二甲双胍缓释片(Ⅳ)等先后获批。今年以来，糖尿病用药已有28个品种（55个受理号）获批上市。米内网数据显示，糖尿病用药在2025年Q1-Q3中国零售药店终端销售额同比增长14.67%。从TOP20品牌来看，2大超10亿品牌领跑，4个国产品牌上榜。截至目前，糖尿病用药1类新药有5个品种（15个受理号）报产在审，其中，江苏恒瑞医药的舒地胰岛素诺利糖肽注射液、深圳君圣泰生物的熊去氧胆小檗碱胶囊均在今年报产。畅销糖尿病药国产第2家诞生，东阳光药、先为达亮眼日前，国家药监局官网显示，北京双鹭药业的西格列汀二甲双胍片(Ⅰ)/(Ⅱ)获批上市。在此之前，安徽金太阳生化药业的吡格列酮二甲双胍片(15mg/500mg)、北京圣永制药的二甲双胍恩格列净片(Ⅰ)、湖南华纳大药厂的二甲双胍恩格列净片(Ⅴ)、正大天晴药业集团的恩格列净二甲双胍缓释片(Ⅳ)、云鹏医药集团的二甲双胍恩格列净片(Ⅰ)、湖南迪诺制药的磷酸西格列汀片、辽宁鑫善源药业的达格列净片同日获批。今年以来糖尿病用药（化+生）新药获批情况来源：米内网中国申报进度（MED）数据库今年以来，糖尿病用药（化+生）已有28个品种（55个受理号）获批上市，其中，3个为新药，宜昌东阳光长江药业的奥洛格列净胶囊、杭州先为达生物的埃诺格鲁肽注射液为1类新药，珠海联邦生物医药的德谷胰岛素注射液为国产第2家。珠海联邦生物医药的德谷胰岛素注射液用于成人糖尿病的治疗，可单独使用或与口服降糖药、餐时胰岛素联合用药，全面满足临床长期血糖管理需求。联邦制药表示，此次获批是公司在糖尿病领域实现关键技术突破的又一重要成果。未来，将持续致力于新产品研发，并重点提升在生物医药行业的竞争力及创造力，深耕慢病治疗领域，以更优质的产品、更完善的管线服务临床、惠及患者。3月25日，联邦制药再传捷报，其全资附属公司联邦生物科技自主研发的1类创新药UBT251注射液已完成在中国2型糖尿病患者中的II期临床研究。奥洛格列净胶囊是东阳光药自主研发的1类创新药，用于单药或联合二甲双胍改善成人2型糖尿病患者的血糖控制。东阳光药表示，此次新品获批将进一步丰富集团在糖尿病产品线的布局，集团将依托成熟的生产体系与营销网络，快速推进该产品的商业化落地，同时持续开展该产品在糖尿病并发症等领域的临床探索，进一步拓展适应症范围，为糖尿病患者提供更全面的治疗解决方案。截至目前，东阳光药在糖尿病用药领域拥有18款产品生产批文。埃诺格鲁肽注射液是先为达生物自主研发的1类创新药，今年1月获批上市，用于成人2型糖尿病患者的血糖控制，是全球首个获批上市的cAMP偏向型GLP-1受体激动剂。3月，埃诺格鲁肽注射液新适应症获批，用于在控制饮食和增加体力活动基础上对成人超重/肥胖患者的长期体重管理，这标志着该药物已完成减重与2型糖尿病双适应症的布局。资料显示，先为达生物建立以核心资产（埃诺格鲁肽注射液等）为基石的强大产品管线，拥有偏向型激动剂发现平台、口服肽给药平台、半衰期延长平台，并基于这三大核心技术平台确立一系列候选药物，构建覆盖GLP-1及其协同机制的全面的产品管线，为代谢性疾病患者提供注射和口服等可持续且高质量的治疗方案。 2大超10亿品牌领跑，扬子江、甘李、华领上榜近年中国零售药店终端糖尿病用药（化+生）销售情况（单位：万元）来源：米内网格局数据库米内网数据显示，糖尿病用药（化+生）在近年中国零售药店（城市实体药店+网上药店）终端销售规模持续扩容，2025年Q1-Q3同比增长14.67%。其中，城市实体药店是主力销售渠道；网上药店则保持快速增长，2025年Q1-Q3销售额已接近2024年全年。从治疗小类来看，GLP-1受体激动剂（化+生）、SGLT2抑制剂（化）、胰岛素及其类似药（化+生）位居前三，合计市场份额占比超过50%。从增速来看，GLP-1受体激动剂（化+生）最快，其次是口服降糖药复方（化），增速均超过30%。从剂型来看，片剂和注射剂为两大主流剂型，合计市场份额占比超过95%。从在销品种数量来看，涉及150个产品，超过700个品牌。 2025年Q1-Q3中国零售药店终端糖尿病用药（化+生）一级集团TOP10 来源：米内网格局数据库集团TOP20中，跨国药企依旧占据前列，诺和诺德、阿斯利康、默克、默沙东、礼来位居前五，前十仅有远大健康和扬子江药业2家国内药企上榜。此外，多家国内药企表现亮眼，恒瑞医药凭借超过200%增速晋身集团TOP20，远大健康、甘李药业、华领医药、正大制药等均有双位数增速。 2025Q1-Q3中国零售药店终端糖尿病用药（化+生）品牌TOP20 来源：米内网格局数据库注：增长率低于10%用*表示品牌TOP20中，诺和诺德的司美格鲁肽注射液和阿斯利康的达格列净片销售额均超10亿元，礼来的替尔泊肽注射液挺进TOP4品牌；4个国产品牌上榜，杭州中美华东制药的吡格列酮二甲双胍片(15mg/500mg)、扬子江南京海陵药业的依帕司他片销售额均超过2亿元，华领医药(上海)的多格列艾汀片、甘李药业的甘精胰岛素注射液增速均超过20%。正增长品牌中，诺和诺德的司美格鲁肽注射液、默克的盐酸二甲双胍片、默沙东的西格列汀二甲双胍片(Ⅱ)、诺和诺德的德谷胰岛素利拉鲁肽注射液等均有双位数增速。从集团层面来看，诺和诺德最多，有7个品种上榜，默沙东和赛诺菲各有2个品种上榜。近年中国零售药店终端司美格鲁肽注射液销售情况（单位：万元）来源：米内网格局数据库司美格鲁肽注射液在2024年中国零售药店终端销售额首次突破20亿元大关，2025年Q1-Q3同比增长10.23%，是糖尿病用药（化+生）TOP1产品。日前，司美格鲁肽在中国核心化合物专利到期，意味着国内药企将加速入场。目前国内仅诺和诺德拥有生产批文，杭州九源基因、石药百克(山东)生物制药、惠升生物制药等10家国内企业报产在审，太极集团重庆涪陵制药、山东新时代药业、海南中和药业等超过20家国内企业获批临床。4月1日，成都倍特生物制药的司美格鲁肽注射液再有10个受理号报产获CDE受理。近年中国零售药店终端多格列艾汀片销售情况（单位：万元）来源：米内网格局数据库多格列艾汀片是华领医药(上海)研发的1类新药，用于改善成人2型糖尿病患者的血糖控制。该产品在近年中国零售药店终端销售规模快速扩容，2023年销售额突破1亿元大关，2024年-2025年Q1-Q3同比增长均超过20%，成为糖尿病用药（化+生）TOP18品牌。不久前，华领医药发布公告，其全球首创新药葡萄糖激酶启动剂（GKA）多格列艾汀已获中国香港特别行政区政府卫生署药物办公室批准上市。公司表示，此次获批不仅为香港2型糖尿病患者带来全新治疗选择，更标志着公司以香港为枢纽，从中国正式进军东南亚及全球市场的战略布局已迈出关键一步。重磅新品不断！恒瑞、君圣泰1类新药来袭今年3月糖尿病用药（化+生）产品报产在审情况来源：米内网中国申报进度（MED）数据库在刚过去的3月，南通联亚药业的利格列汀二甲双胍缓释片、烟台鲁银药业的达格列净二甲双胍缓释片(Ⅰ)、安徽万邦医药科技的氢溴酸替格列汀片等多个糖尿病用药报产获CDE受理。其中，江苏恒瑞医药的舒地胰岛素诺利糖肽注射液、深圳君圣泰生物的熊去氧胆小檗碱胶囊2个为1类新药，而深圳君圣泰生物的熊去氧胆小檗碱胶囊则是公司提交的首个新药上市申请。来源：米内网项目进度数据库截至目前，糖尿病用药（化+生）1类新药有5个品种（15个受理号）报产在审，其中，恒瑞医药最多，有舒地胰岛素诺利糖肽注射液、HRS9531注射液、舒地胰岛素注射液3个品种报产在审。资料来源：米内网数据库、公司公告等注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准

2026-03-30

·allsci.com

FDA approves Novo Nordisk’s Awiqli, the first once-weekly basal insulin for type 2 diabetes

The US FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL, developed by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The decision makes Awiqli the first and only once-weekly basal insulin approved by the US FDA, reducing the injection frequency from seven times per week to one. It is also the first change to basal insulin dosing frequency in more than two decades, since the introduction of once-daily long-acting analogs such as insulin glargine around the year 2000. Awiqli is already approved in the EU and 13 additional countries. The approval covers use of the weekly insulin in combination with mealtime insulin or with common oral anti-diabetic agents and GLP-1 receptor agonists. It is administered via the Awiqli FlexTouch pen on the same day each week. The product is not approved for use in children or adolescents. Novo Nordisk said Awiqli will be available nationwide in the US in the coming months. The insulin icodec FDA approval is supported by the ONWARDS Phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials enrolling approximately 2,680 adults with uncontrolled type 2 diabetes. These trials evaluated once-weekly Awiqli against daily basal insulins, including insulin glargine U-100 (ONWARDS 1) and insulin degludec (ONWARDS 2, ONWARDS 3), across both insulin-naive patients and those switching from daily basal or basal-bolus regimens (ONWARDS 4). The primary endpoint across the program was reduction of HbA1c, and the company reported that Awiqli demonstrated efficacy on this measure. The safety profile was described as consistent with the daily basal insulin class. Common adverse events included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, peripheral edema, and weight gain. The approval of Novo Nordisk insulin icodec addresses a long-recognized gap in type 2 diabetes management. Despite the availability of effective daily basal insulins, adherence remains a persistent challenge. Injection fatigue, missed doses, and what clinicians term “psychological insulin resistance” — reluctance among patients and providers to initiate insulin therapy — contribute to suboptimal glycemic control in a substantial proportion of the estimated 37 million Americans living with type 2 diabetes. Research has indicated that weekly injectable diabetes medications may be associated with improved adherence, and Awiqli’s once-weekly dosing is designed to reduce the burden that daily injections impose. The weekly insulin for type 2 diabetes enters a treatment landscape that has been reshaped in recent years by the arrival of GLP-1 receptor agonists such as semaglutide and dual GIP/GLP-1 agonists such as tirzepatide, both of which offer HbA1c reduction alongside weight loss and cardiovascular benefits. Awiqli occupies a distinct niche as a basal insulin rather than an incretin-based therapy, targeting patients who require insulin but may benefit from a less frequent dosing schedule. Eli Lilly is developing insulin efsitora alfa, another once-weekly basal insulin currently in late-stage clinical development, which would make this a directly competitive space if approved. For Novo Nordisk, securing the first-mover position with Awiqli adds to a diabetes portfolio that already includes insulin degludec (Tresiba), insulin aspart (NovoLog), and the combination product Xultophy. The approval does not resolve all unmet needs in basal insulin therapy. Hypoglycemia risk remains present, weight gain is listed among common side effects, and the US approval does not include type 1 diabetes. Whether the reduction in injection frequency translates into measurable improvements in real-world adherence and long-term glycemic outcomes will require post-marketing data. Nonetheless, the availability of a once-weekly basal insulin option represents a structural shift in how insulin therapy can be delivered to the large population of adults with type 2 diabetes who need it. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

上市批准临床3期

2026-03-18

·百度百家

GLP-1复方制剂之后

（来源：动脉新医药）近日，恒瑞医药发布公告，其自主研发的舒地胰岛素诺利糖肽注射液，上市申请正式获国家药监局受理。这是一款由长效基础胰岛素类似物和胰高血糖素样肽-受体激动剂（GLP-1RA）组成的固定比例复方制剂。拟定适应症指向血糖控制不佳的成人2型糖尿病患者，在饮食和运动基础上联合其他口服降糖药物，改善血糖控制。业界的第一反应是：恒瑞医药又在糖尿病领域落下一子，继瑞格列汀、恒格列净和二甲双胍之后，代谢板块即将迎来一款重磅药物。但是这款产品的受理，似乎更像是一场守卫战的开端，而非冲锋号。上海市卫生和健康发展研究中心主任金春林向动脉网表示，总体而言，恒瑞医药的战略意图仍是守住代谢病领域，这款产品更可能作为基石产品，巩固恒瑞在糖尿病治疗领域的防线，此次受理的复方制剂可视为“前菜”，后续的多靶点口服减重产品或许才是真正的主力。 “尽管挑战巨大，但凭借全面布局代谢病的决心和现有深厚积累，恒瑞有望成为国内乃至全球代谢病领域强劲的竞争者。” 01. 先守城：为后续管线“抢时间” 舒地胰岛素诺利糖肽注射液（HR17031）的价值，体现在两项关键Ⅲ期临床研究的数据里。北京大学人民医院纪立农教授牵头HR17031-301研究，以及天津医科大学朱宪彝纪念医院陈莉明教授牵头HR17031-302研究，分别针对口服降糖药控制不佳、基础胰岛素控制不佳的两类患者。结果显示，在主要终点上，舒地胰岛素诺利糖肽均显著优于试验对照组，且长期安全性与耐受性良好。据了解，这款产品的机制其实很清晰：把两种机制互补的药物——长效胰岛素和GLP-1RA——合二为一。胰岛素能有效降糖，但伴随低血糖和体重增加的风险；GLP-1RA则刚好弥补这方面不足，还能额外增强降糖效果，实现“1+1>2”的治疗增益。在金春林看来，这类药物的核心价值在于直击临床痛点——将每日需分别注射的两种药物合二为一，每天少打一次针，患者依从性自然提高。但这并非全新的赛道，全球范围内，同类药品早已上市——诺和诺德的德谷胰岛素利拉鲁肽注射液（诺和益）和赛诺菲的甘精胰岛素利司那肽（赛益宁）注射液，根据EvaluatePharma数据库，2025年这两款产品的全球销售额约为10.18亿美元。在中国市场，据梳理，德谷胰岛素利拉鲁肽注射液于2021年10月获批，2022年正式上市。诺和诺德方面数据显示，该药物在中国区的销售收入从2022年的0.45亿元飙升至2024年的14.26亿元，年均复合增长率高达463%。 2023年1月，赛诺菲的甘精胰岛素利司那肽注射液获批上市，被写入《中国2型糖尿病防治指南》等国内外多个权威指南与共识。面对这两大巨头，国内药企并未缺席。除了恒瑞医药，根据摩熵医药数据，通化东宝、联邦制药、正大天晴、惠升生物、东阳光生物、华领医药等企业均在布局糖尿病复方制剂，其中通化东宝和联邦制药均已进入III期临床阶段。竞争似乎会越来越激烈拥挤，金春林分析称，尽管恒瑞医药在糖尿病市场已有较好布局，但这款产品能否改变市场格局仍需审慎看待。目前GLP-1赛道的竞争核心已转向减重效果和多靶点创新药，市场竞争非常拥挤。恒瑞医药的舒地胰岛素诺利糖肽注射液更偏向组合优化策略，旨在通过简化治疗流程，在现有市场中进行渗透和替代，而非开辟全新赛道。 “这款产品更可能作为基石产品，巩固恒瑞在糖尿病治疗领域的防线，守住阵地，为其后续开发更具颠覆性的创新药争取时间，总体而言，它对市场格局的影响有限，更多是一种防守型布局。”金春林向动脉网表示。 02. 再亮剑：三款“王牌”藏在后方真正的主角，或许藏在恒瑞医药的管线深处。据梳理，在代谢性疾病领域，恒瑞医药已有恒格列净、瑞格列汀等5款产品获批上市，但真正让外界瞩目的，是三款处于后期研发阶段的减重创新药。第一款是瑞普泊肽（HRS9531），GLP-1/GIP双受体激动剂，同时开发每周一次皮下注射和每日一次口服片剂，拟用于肥胖和超重治疗。 2026年2月，瑞普泊肽片在中国肥胖成人中的Ⅱ期临床试验公布顶线数据：治疗第26周时，参与者较基线平均体重下降最高达12.1%，且未观察到平台期，同时呕吐发生率不超过11.4%。目前，每日一次的口服瑞普泊肽片即将进入Ⅲ期试验，瑞普泊肽注射液的上市申请已获国家药监局受理。第二款是HRS-7535，一款口服小分子GLP-1受体激动剂，目前已在降糖和减重开展Ⅲ期注册临床研究，预计将于2026年陆续公布研究结果。口服减重药物当前市场正热，高盛预测，全球减肥药物市场规模在2030年有望突破1000亿美元，到2030年和2035年，口服减重药将分别占据减重药市场24%和32%。第三款是HRS-4729，一款GLP-1R/GIPR/GCGR三靶点受体激动剂。与双靶点相比，增加GCG靶点激活后，可促进能量消耗、降低血脂，更好地发挥减重效果。该药已于2024年12月获得临床试验批准，用于超重/肥胖适应症，目前在中国已推进Ⅰ期；2025年，用于代谢相关脂肪性肝病/代谢相关脂肪性肝炎适应症获批临床。目前国内外尚无同类产品获批上市，但值得一提的是，礼来的三靶点药物Retatrutide目前正在开展肥胖、2 型糖尿病、心血管事件二级预防、阻塞型睡眠呼吸暂停等适应症的 III 期临床。恒瑞的这三款产品，构成了其GLP-1减重领域的“主力梯队”。金春林向动脉网分析，恒瑞医药在代谢领域的布局体现了清晰的策略：一方面通过现有产品巩固市场防线，另一方面积极布局前沿技术，构建护城河。其产品线覆盖了从口服到注射的多种剂型，以及从双靶点到三靶点的多种作用机制，占据了代谢领域的多个技术高地。 “这种广撒网的策略，能够有效分散单一药物研发失败的风险，确保未来拥有多个增长点。通过这样的布局，恒瑞旨在对标诺和诺德、礼来等国际巨头，在庞大的代谢病市场中构建一个覆盖糖尿病、肥胖及潜在心血管获益的完整产品矩阵，从而提升产品推向市场的效率。” 与此同时，一场全球化的布局已然展开。恒瑞医药已将包括瑞普泊肽、HRS-7535、HRS-4729在内的GLP-1类创新药组合相关权益授权给美国Kailera Therapeutics公司，交易总额可达60亿美元，恒瑞医药还获得了Kailera 19.9%的股权。完成交易后，Kailera已拿到两笔共10亿美元融资，Kailera正在完成“从中国临床起步—资产剥离—独立融资与全球开发”的路径演化。由此来看，恒瑞医药的意图很明确：把产品送出去，把资本引进来，把战场铺向全球。 03. 接着闯关：“卷王”赛道里的持久战对于恒瑞医药来说，代谢减重领域前方的道路似乎并不平坦，2026年的减重药物市场，已是硝烟弥漫。 2026年1月，诺和诺德的口服减重药Wegovy于在美国上市，瑞银预计第一季度处方量可达40万张。 2026年2月，诺和诺德的司美格鲁肽与礼来的替尔泊肽上演“药王”之争——2025年替尔泊肽凭借超365亿美元收入反超司美格鲁肽（361亿美元），登顶全球畅销药榜首。 2026年3月，翰森制药的奥莱泊肽在Ⅲ期研究中交出亮眼成绩单：治疗48周，平均体重降幅最高达19.3%，且恶心发生率不到10%，呕吐不到5%。同是3月，礼来宣布计划投资30亿美元，全面扩展在华供应链产能，布局口服小分子GLP-1受体激动剂orforglipron的本土生产。跨国巨头正加速本土化布局，将竞争推向纵深。面对这样的竞争格局，金春林告诉动脉网，恒瑞的优势与挑战同样显著。据金春林分析，恒瑞医药的核心优势首先在于研发与临床的长期积累：首先，在糖尿病患者中已积累大量安全性与有效性数据，为减重适应症的开发提供了坚实基础和信心。其次，其内代谢管线拥有强大的销售网络和长期的医生合作关系，产品获批后能够借助现有渠道迅速触达核心市场，营销能力强劲。此外，恒瑞的管线组合具备差异化潜力，双靶点、三靶点产品在临床数据上呈现出同类最优的潜力，为未来市场竞争提供了差异化底气。然而挑战同样严峻。在金春林看来，一方面，减重赛道竞争已白热化，诺和诺德、礼来等巨头开始降价，叠加司美格鲁肽专利到期及国内众多仿制药的冲击，恒瑞医药产品一旦上市就可能面临价格大幅向下、竞争白热化的市场格局。另一方面，诺和诺德的司美格鲁肽和礼来的替尔泊肽已在全球建立强大的品牌认知和医生患者教育基础，品牌壁垒较高，竞争难度大。 “此外，作为后来者，恒瑞的减重产品将面临艰难的医保谈判，市场预期需相应调整。为了进入医保，定价策略至关重要，若缺乏优于竞争对手的临床疗效数据支撑，医保谈判压力将非常大。”金春林向动脉网表示。恒瑞的这场代谢“守卫战”将是一场持久战。由此看来，舒地胰岛素诺利糖肽的受理，可能只是恒瑞代谢战役中的一役，真正的主力——瑞普泊肽、HRS-7535、HRS-4729——还在后方蓄力。面对巨头的围堵、仿制药的冲击、医保谈判的压力，恒瑞的底气来自二十余年深耕代谢领域的积累，来自多靶点管线的差异化布局，也来自全球化授权的战略眼光。这场守卫战的终局，或许不是一举夺魁，而是在群雄环伺中，守住自己的阵地，成为中国乃至全球代谢病领域不可忽视的竞争者。

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	鏇鹽選鹹製蓋艱壓網夢(醖艱艱醖鬱願願遞積積) = 鬱構築衊構繭夢簾壓簾鑰簾鬱選遞積積鹹繭艱 (夢網餘艱獵窪鹽鬱餘鏇, - 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)	窪鬱壓範鏇齋齋衊齋遞(鬱獵衊壓觸遞廠繭願餘) = 夢淵鹽願窪糧襯憲簾鬱築觸餘觸壓憲蓋觸範顧 (壓顧鹹艱鹹糧壓築鬱簾, 2.29) 更多	-	2023-09-08
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	窪鬱壓範鏇齋齋衊齋遞(鬱獵衊壓觸遞廠繭願餘) = 網顧膚蓋餘壓艱蓋網衊築觸餘觸壓憲蓋觸範顧 (壓顧鹹艱鹹糧壓築鬱簾, 1.79) 更多
EASD2022	N/A	2型糖尿病 HbA1c \| c-peptide	73	Human BBT	鬱齋襯構鏇淵獵窪淵鬱(醖餘積淵糧餘齋範廠鏇) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia 夢鬱網鏇窪鹽艱築製構 (積廠網蓋艱壓鏇簾鹽製 )	积极	2022-09-20
				IDegLira
DUAL I China (Pubmed \| J Diabetes)	临床3期	2型糖尿病	-	IDegLira	構鑰夢網糧選選選憲鹽(窪製範積鑰網餘獵獵繭): 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	壓醖憲餘夢製觸餘餘窪(壓鏇鏇襯鬱願鹹範鹽膚): 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	鬱觸簾鏇願鑰構壓繭選(繭獵淵廠鑰構範壓鬱繭): 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)	壓餘醖範鬱範淵淵願衊(艱鏇鹹簾觸窪艱齋醖鹹) = 蓋鬱醖築鑰糧衊膚網範顧淵鹽蓋網蓋遞窪鹽淵 (鬱夢構餘憲繭鹹衊艱鑰, 0.88) 更多	-	2020-07-07
				Insulin Degludec (Insulin Degludec)	壓餘醖範鬱範淵淵願衊(艱鏇鹹簾觸窪艱齋醖鹹) = 鹹選獵製顧壓衊獵網鏇顧淵鹽蓋網蓋遞窪鹽淵 (鬱夢構餘憲繭鹹衊艱鑰, 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)	憲艱蓋齋網構顧構簾鏇(遞憲範願範繭鬱鏇鏇鑰) = 鑰醖淵艱衊蓋簾鹽衊淵衊窪窪觸艱醖膚醖蓋蓋 (遞遞範壓願醖蓋顧壓築, 1.14) 更多	-	2020-03-19
				Insulin Degludec (Insulin Degludec)	憲艱蓋齋網構顧構簾鏇(遞憲範願範繭鬱鏇鏇鑰) = 醖網廠願壓願鏇鏇壓簾衊窪窪觸艱醖膚醖蓋蓋 (遞遞範壓願醖蓋顧壓築, 1.19) 更多
NCT02420262 \| NCT01952145 (Pubmed \| Diabet Med)	临床3期	2型糖尿病	-	Insulin degludec/liraglutide (IDegLira)	繭廠鏇網壓蓋鹽遞夢鏇(製觸鏇醖膚蓋廠糧鏇憲) = 齋窪鹽醖鏇衊窪蓋窪製鬱願廠範膚膚築鬱範膚 (鹹膚憲膚齋蓋醖觸簾醖 ) 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	鏇顧衊壓鏇遞簾獵餘膚(蓋艱醖膚製鑰餘築襯鹽): ETD = -13.98 (95% CI, -16.41 ~ -11.55), P-Value = <0.0001 更多	优效	2019-12-01
				metformin+degludec