主要目的：通过评估第24周糖化血红蛋白A1c（HbA1c）较基线的变化，证实iGlarLixi与IDegAsp相比在HbA1c控制方面的非劣效性。次要目的：与IDegAsp相比，证明iGlarLixi对治疗24周后HbA1c和体重变化、达到HbA1c目标的受试者比例、达到HbA1c目标且体重未增加的受试者比例以及在此基础上未发生低血糖的受试者比例方面的治疗效果的优效性；与IDegAsp相比，进一步评估iGlarLixi治疗24周后对其他血糖控制参数的治疗效果；评估24周治疗期间的胰岛素总剂量和需要补救治疗的受试者百分比；与IDegAsp相比，评估iGlarLixi的安全性和耐受性。

开始日期2022-07-07

申办/合作机构

Sanofi-Aventis Deutschland GmbH

[+2]

NCT05413369 / Completed临床3期

A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)

This is a parallel-group treatment, Phase 3, randomized, 2-arm study to assess the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s).
Study details include:
Study duration per participant: approximately up to 27 weeks
Treatment duration: 24 weeks
Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There will be 14 visits including 7 phone call and 7 on-site visits in total during screening and treatment periods. There will be a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment.
Health measurement/Observation: change in HbA1c as the primary endpoint.
Intervention name: iGlarLixi and IDegAsp
Participant sex: male and female
Participant age range: adults at least 18 years of age
Condition/disease: Type 2 diabetes mellitus
Study hypothesis: Compared to IDegAsp, iGlarLixi will demonstrate a similar therapeutic effect on glycemic control assessed by change in HbA1c from baseline to Week 24 in the study participants.

开始日期2022-07-07

申办/合作机构

Sanofi SA

NCT05114590 / Completed临床4期

A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes Mellitus

The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs [OADs] with or without a glucagon-like peptide 1 receptor agonist [GLP1 RA]), as measured by continuous glucose monitoring (CGM).
The total study duration per participant was approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts were scheduled.
A screening period of up to 2 weeks
A run-in period of up to 2 weeks, including the baseline period
A 16-week, open-label treatment period
A 2-week post-treatment safety follow-up period

开始日期2022-01-27

申办/合作机构

Sanofi

100 项与甘精胰岛素利司那肽相关的临床结果

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100 项与甘精胰岛素利司那肽相关的转化医学

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100 项与甘精胰岛素利司那肽相关的专利（医药）

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115

项与甘精胰岛素利司那肽相关的文献（医药）

2023-12-01·Diabetes therapy : research, treatment and education of diabetes and related disorders

Budget Impact Analysis of Intensification with iGlarLixi Compared to Alternative Treatment Strategies Among Patients with Type 2 Diabetes Mellitus.

Article

作者: Revel, Andrew ; Shah, Tejaswinee ; Samnaliev, Mihail ; Srinivas, Sistla S S ; Jain, Divya ; Charland, Scott ; Dex, Terry ; Ken-Opurum, Jennifer ; Preblick, Ronald

INTRODUCTION:

The clinical benefits of treating patients with type 2 diabetes mellitus (T2DM) with fixed-ratio combination of insulin iGlar (iGlar) plus lixisenatide (iGlarLixi) were demonstrated in clinical trials and real-world evidence studies; however, its cost impact to healthcare payers is unknown.

METHODS:

A budget impact model was developed from a United States (US) payer's perspective for a hypothetical healthcare plan of 1 million people over a 1-year time horizon. In scenario analysis, patients with uncontrolled glycated hemoglobin (HbA1c) treated with 60 units or less of daily insulin (insulin cohort) or oral antidiabetic drugs (OADs) only (OAD cohort) were intensified to iGlarLixi/rapid-acting insulin (RAI)/glucagon-like peptide 1 receptor agonists (GLP-1RA) or iGlarLixi/iGlar/GLP-1RA, respectively. Model inputs from real-world data (RWD) included baseline market shares, proportion of patients intensifying to respective treatments, and dosing inputs; unit costs were obtained from published literature. One-way sensitivity analyses assessed the impact of individual parameters.

RESULTS:

Intensification with iGlarLixi resulted in the lowest incremental per member per month (PMPM) budget impact compared to other intensifying drugs (iGlar, RAI, and GLP-1RA). In the insulin cohort, the incremental PMPM cost for intensification with iGlarLixi ($0.03) was the lowest among intensifying drugs; GLP-1RA ($72.20) and RAI ($4.81). Similarly, the incremental PMPM cost for intensification with iGlarLixi was the lowest ($1.25) in the OAD cohort among intensifying drugs; GLP-1RA ($321.65) and iGlar ($114.82). In scenario analyses, when equal market intensification shares for iGlarLixi and GLP-1RA were explored, the incremental PMPM cost for iGlarLixi ($0.03) remained lower than GLP-1RA ($2.28) and RAI ($10.44) in the insulin cohort.

CONCLUSIONS:

Intensification with iGlarLixi was associated with lower costs compared to other treatment intensifications, as well as overall budget reductions compared to pre-intensification when considering cost savings attributable to reduction in HbA1c; therefore, its inclusion for the treatment of T2DM would represent a budget saving.

2023-10-01·EClinicalMedicine

Glucometabolic outcomes of GLP-1 receptor agonist-based therapies in patients with type 2 diabetes: a systematic review and network meta-analysis

Article

作者: Caruso, Irene ; Perrini, Sebastio ; Laviola, Luigi ; Palmer, Suetonia Cressida ; Strippoli, Giovanni F M ; Cignarelli, Angelo ; Giorgino, Francesco ; Natale, Patrizia ; Di Molfetta, Sergio ; Natalicchio, Annalisa ; Di Gioia, Ludovico

Background:

Innovative GLP-1 receptor agonist (GLP-1RA)-based treatment strategies-such as tirzepatide, GLP-1RA plus basal insulin fixed-ratio combinations [FRC], GLP-1RA plus sodium glucose cotransporter-2 inhibitors [SGLT-2i] combinations, and high-dose GLP-1RA-have been listed among the most efficacious options for type 2 diabetes management. However, differences in their glucometabolic effects have not been assessed in dedicated head-to-head trials. In the absence of such trials, we aimed to provide a useful comparison among these treatment strategies to guide clinical practice.

Methods:

In this network meta-analysis, we searched PubMed, MEDLINE, and Web of Science (from database inception to June 24, 2023) for randomised controlled studies, published in English, that enrolled individuals with type 2 diabetes treated with tirzepatide, iGlarLixi, iDegLira, GLP-1RA plus SGLT-2i combination, or high-dose GLP-1RA (dulaglutide 3 mg and 4.5 mg, semaglutide 2 mg) compared with placebo or active comparators. Eligible studies reported change from baseline in HbA1c as an outcome, which was the primary outcome of this analysis. Secondary outcomes were changes in fasting and post-prandial glucose, bodyweight, LDL-cholesterol, blood pressure and risk of hypoglycaemia. We assessed risk of bias through the Cochrane Collaboration's tool (RoB2 tool), publication bias through visual inspection of funnel plots and Egger's test, and heterogeneity by comparing the magnitude of the common between-study variance (τ²) for each outcome with empirical distributions of heterogeneity variances. This network meta-analysis was registered in PROSPERO (CRD42022329878).

Findings:

40 trials were included. Tirzepatide 15 mg ranked first in terms of HbA1c reduction compared to other GLP-1RA-based strategies, even those including insulin (vs. iDegLira MD -0.40%, 95% CI [-0.66; -0.14], low certainty; vs. iGlarLixi MD -0.48%, 95% CI [-0.75; -0.21], low certainty), without increasing the risk of hypoglycaemia (vs. iDegLira OR 0.35, 95% CI [0.16; 0.79], high certainty; vs. iGlarLixi OR 0.31, 95% CI [0.20; 0.48], high certainty). Tirzepatide 15 mg was also the most efficacious on weight lowering, even compared to high-dose GLP-1RA (eg, semaglutide 2 mg MD -6.56 kg, 95% CI [-7.38; -5.73], low certainty) and GLP-1RA plus SGLT-2i combination (MD -4.61 kg, 95% CI [-5.29; -3.93], low certainty). Risk of bias and publication bias were generally low throughout studies, while high levels of heterogeneity were detected for most outcomes.

Interpretation:

Aiming to support clinicians in tailoring treatment to patients' needs, we suggest that a hierarchy among treatment strategies be devised considering the best options for type 2 diabetes. Tirzepatide, followed by GLP-1RA plus basal insulin FRC and GLP-1RA plus SGLT-2i combination, was associated with greater benefit on HbA1c than high-dose GLP-1RA.

Funding:

Fondazione per la Ricerca Biomedica "Saverio e Isabella Cianciola" and Next Generation EU, in the context of the National Recovery and Resilience Plan, Investment PE8-Project Age-It: Ageing Well in an Ageing Society.

2023-09-01·PharmacoEconomics - open

A Relative Cost of Control Analysis of IDegLira versus Other Forms of Basal Insulin Intensification in Mexico.

Article

作者: Sekharan, Manisha ; Morales-Villegas, Enrique ; Pariti, Bhrugu ; García-Appendini, Ida Caterina ; López-Forero, Carmen Alicia ; Osorio-Hernández, Mariana ; Deshwal, Swati ; Garnica-Cuellar, Juan Carlos ; Monroy-Cruz, Bárbara

OBJECTIVES:

Achieving glycemic control in patients with type 2 diabetes is important as it reduces the risk of complications and their related clinical and economic burden. Yet therapeutic inertia due to the fear of hypoglycemia, complex treatment regimens, weight gain, and therapy costs, among others, limits achieving glycemic control. This analysis aims to assess the short-term cost of control (cost per patient achieving treatment goals) with insulin degludec/liraglutide (IDegLira) versus other forms of basal insulin intensification (insulin glargine titration, basal-bolus therapy, and the combination of insulin glargine and lixisenatide: IGlarLixi) in type 2 diabetes patients not controlled with basal insulin in the Mexican private setting.

METHODS:

The proportion of patients achieving treatment goals was obtained from DUAL V and DUAL VII studies (full trial population) and a indirect treatment comparison analyzing IDegLira versus IGlarLixi. Annual cost of treatment was estimated using unitary costs from IQVIA's Pharmaceutical Market Mexico (PMM) audit and wholesale acquisition costs (both from December 2021). The cost of control was estimated by dividing the annual cost of treatment by the proportion of patients achieving the corresponding treatment goal: glycated hemoglobin (HbA1C) < 7.0%, HbA1C < 7.0% without weight gain, HbA1C < 7.0% without hypoglycemia, and HbA1C < 7.0% without hypoglycemia and weight gain. One-way sensitivity analyses were conducted to assess how variations in the model inputs impacted cost-effectiveness outcomes.

RESULTS:

The proportion of patients achieving treatment goals was higher for IDegLira versus other forms of basal insulin intensification in all endpoints assessed. The annual cost of treatment with IDegLira was similar to the cost of treatment versus IGlarLixi or versus basal-bolus therapy ($54,659 versus $55,831 MXN and $51,008 versus $52,987 MXN, respectively), and higher in comparison with insulin glargine titration ($52,186 versus $40,194 MXN). The cost of controlling one patient with IDegLira was lower than any other form of basal insulin intensification, for all treatment goals.

CONCLUSION:

When integrating the greater clinical efficacy of IDegLira with its annual cost, it can be shown that within 1 year, IDegLira is the best option in terms of value for money for payers in a private healthcare setting in Mexico in comparison with other forms of basal insulin intensification. Thus, investing in IDegLira not only represents a greater clinical benefit, but also an economical one for payers.

137

项与甘精胰岛素利司那肽相关的新闻（医药）

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

2024-06-26

·echemi

Novo Nordisk's Semaglutide - A Breakthrough in Obesity Management

Semaglutide, the active ingredient in Novo Nordisk's Wegovy®, is a GLP-1 receptor agonist that works by binding to and activating the GLP-1 receptor, thereby exerting its effects in the treatment of obesity. Given that the GLP-1 receptor is involved in the specific brain regions that regulate appetite, the application of Wegovy® in obese patients can significantly reduce hunger, enhance satiety, and decrease food cravings, thereby assisting patients in reducing caloric intake and achieving weight loss. Moreover, through genetic engineering, Wegovy® has been successful in extending its half-life to 7 days, allowing for a once-weekly dosing regimen, providing Chinese patients with a safe and convenient weight management solution. Zhangkezhou, the Corporate Vice President of Pharmaceutical Quality at Novo Nordisk Greater China, stated that Novo Nordisk's research in the field of obesity treatment has spanned over 25 years, and the company has established a solid scientific foundation based on GLP-1RA therapy. The company is committed to comprehensively addressing the overall health of obese patients and aims to provide them with an integrated treatment plan. Looking ahead, Novo Nordisk will continue to lead the innovative breakthroughs in the field of obesity treatment to meet the diverse medical needs of Chinese patients. Zhou Xiaping, the Global Senior Vice President and President of Novo Nordisk Greater China, emphasizes that as a global leader in the field of obesity treatment, Novo Nordisk is dedicated to changing the world's perception, prevention, and treatment of obesity. Coinciding with Novo Nordisk China's 30th anniversary, Wegovy® as the company's latest innovative drug introduced to China will effectively address the unmet medical needs in the field of obesity treatment in China. The company is grateful for the support and guidance from the National Medical Products Administration and relevant government departments in accelerating the introduction of innovative drugs to China, as well as the contributions of researchers and participants in the clinical trials. Novo Nordisk will uphold its mission of "driving change and working together to overcome serious chronic diseases" and focus on patient-centricity, accelerating innovation, and diversifying and comprehensively contributing to the prevention and treatment of chronic diseases in China, supporting the "Healthy China 2030" initiative. It is hereby declared that the approved Wegovy® (for long-term weight management in adults) and the already marketed Ozempic® (for the treatment of type 2 diabetes in adults) are both prescription drugs, targeting different diseases and cannot be substituted for each other. About Wegovy® (semaglutide injection for long-term weight management) Wegovy® is the world's first and currently the only once-weekly GLP-1RA for long-term weight management, providing not only significant weight loss but also multiple health benefits. Wegovy® has been launched in over 10 countries and regions globally. Wegovy® is indicated for long-term weight management in adults with an initial body mass index (BMI) of: - BMI ≥ 30 kg/m² (obesity) - BMI 27 kg/m² to < 30 kg/m² (overweight) with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Wegovy® can achieve an average weight loss of 17% (16.8 kg) and provide multiple health benefits, including reduced waist circumference, decreased visceral fat, improved lipid profile, and delayed progression to type 2 diabetes. In the global STEP clinical trial series covering over 25,000 overweight and obese participants, as well as real-world data studies, Wegovy® has demonstrated good safety and tolerability. Its active ingredient, semaglutide, has up to 94% structural homology with human GLP-1 and has been extensively validated for its safety, used by 5.4 million patients globally. The most common adverse reactions of Wegovy® are mild to moderate transient gastrointestinal events. About the STEP Clinical Trial Series The STEP clinical trial series for Wegovy® (semaglutide injection for long-term weight management) started in June 2018 and has completed 14 trials to date, including 12 global Phase 3 trials, 1 regional Phase 3 trial in East Asia, and 1 regional Phase 3 trial primarily in China. These trials have study durations of 11-24 months, with an average maximum treatment period of 34 months, aiming to evaluate the efficacy, safety, and other health benefits of Wegovy® in the long-term weight management of adults. Overall, the STEP clinical trial data have shown that Wegovy® can significantly reduce the weight of adult overweight and obese patients across different regions, ethnicities, ages, and genders, with or without type 2 diabetes, with an average weight loss of 17% (16.8 kg), and has demonstrated good safety and tolerability.

临床3期上市批准临床结果

100 项与甘精胰岛素利司那肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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	瑞士	Sanofi-Aventis U.S. LLC	2002-05-16

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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


NCT05413369 (SoliD, ADA2024) 人工标引	临床3期	2型糖尿病	582	iGlarLixi	範築壓窪簾構憲築觸餘(窪糧艱艱築遞醖夢鬱艱): Difference = -0.20 (95% CI, -0.33 ~ -0.07), P-Value = <0.001 更多	非劣	2024-06-21
				IDegAsp
NCT05114590 (CTgov)	临床4期	2型糖尿病	124	Insulin glargine/Lixisenatide	簾膚蓋窪範襯築遞膚淵(製蓋鏇窪遞淵襯觸願糧) = 觸醖鏇範醖襯網蓋鑰淵遞廠範獵築夢顧醖壓蓋 (窪遞鑰憲選齋獵夢壓網, 廠憲廠鹽築選選簾鬱構 ~ 廠鏇餘遞廠壓艱壓夢獵) 更多	-	2024-05-24
CHANCE (ADA2023)	N/A	2型糖尿病	70	iGlarLixi	艱鹹淵醖壓夢鹽膚獵顧(顧夢廠鏇網廠廠壓獵鏇) = 築襯簾壓廠構壓簾艱簾製鹽廠構製糧膚襯網顧 (築獵衊積淵範齋網糧積 ) 更多	积极	2023-06-20
LixiLan-L (ADA2023)	N/A	2型糖尿病	366	iGlarLixi	顧夢襯襯鬱網築積積淵(築壓廠網糧遞鬱壓鬱齋) = 範壓觸網衊範獵憲觸鹽鹹繭醖壓鹽製餘餘範積 (齋繭窪鹹構窪艱窪淵簾 )	-	2023-06-20
ADA2023	N/A	2型糖尿病	1,317	iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (Insulin naïve)	淵積鏇鏇壓醖網網鏇網(膚選醖構顧遞鏇鹹壓鹽) = 願膚觸鹹淵鹹獵鹽築製積襯醖蓋艱鏇獵製獵醖 (鏇蓋遞簾鏇醖顧製襯艱 ) 更多	-	2023-06-20
				Insulin treated	淵積鏇鏇壓醖網網鏇網(膚選醖構顧遞鏇鹹壓鹽) = 憲選衊蓋鹽觸齋艱膚遞積襯醖蓋艱鏇獵製獵醖 (鏇蓋遞簾鏇醖顧製襯艱 ) 更多
Pubmed	临床3期	2型糖尿病	-	iGlarLixi	齋窪糧顧願簾餘鑰鹽餘(願醖鹽艱鹹餘壓簾壓壓): P-Value = 11.45	-	2023-03-30
				Glargine 100 U/mL
EASD2022	N/A	骨折	-	GLP-1RA	願簾願鏇窪顧夢膚網獵(觸鏇鑰願窪夢鏇憲艱衊): HR = 0.89 (95% CI, 0.76 ~ 1.05)	积极	2022-09-22
				DPP-4i
NCT03798080 (LixiLan-L-CN, Pubmed) 人工标引	临床3期	2型糖尿病	426	iGlarLixi	膚觸鏇壓顧夢膚醖觸鏇(獵鹹遞鹽鏇製鏇範鹹鹹) = 艱簾鑰衊膚衊繭衊艱選窪鹹餘鑰構夢襯醖製衊 (範簾獵蓋範製艱廠鏇膚 ) 更多	优效	2022-06-28
				insulin glargine	膚觸鏇壓顧夢膚醖觸鏇(獵鹹遞鹽鏇製鏇範鹹鹹) = 築範簾窪鏇構衊夢網鑰窪鹹餘鑰構夢襯醖製衊 (範簾獵蓋範製艱廠鏇膚 ) 更多
NCT03767543 (LixiLan ONE CAN, Pubmed)	临床3期	2型糖尿病	265	Daily titration of iGlarLixi	獵觸窪遞餘艱鏇築襯鏇(鹽鹹鬱蓋齋觸鹽膚淵積) = 糧鏇構艱窪繭選顧衊衊鏇觸襯齋繭醖淵鑰觸鹽 (淵築鬱鏇積積鹽鏇遞蓋 ) 更多	积极	2022-06-07
				Weekly titration of iGlarLixi	獵觸窪遞餘艱鏇築襯鏇(鹽鹹鬱蓋齋觸鹽膚淵積) = 膚構鑰簾蓋夢夢鏇獵襯鏇觸襯齋繭醖淵鑰觸鹽 (淵築鬱鏇積積鹽鏇遞蓋 ) 更多
ADA2022	N/A	2型糖尿病	1,303	iGlarLixi (Pre-Breakfast)	窪淵蓋鏇鑰壓壓膚齋繭(憲繭獵築淵顧艱鑰製齋) = 襯壓襯艱窪顧顧積顧積獵簾築憲醖製糧製憲艱 (衊淵範積廠願範糧構鏇 )	-	2022-06-01