A Three-Part, Randomized, Double-Blind (Part A) and Open-Label (Part B and Part C), Multi-Dose, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus

The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.
The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.
The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Degludec given via intravenous (IV) infusion.
The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period.

开始日期2024-05-15

申办/合作机构

Eli Lilly & Co.

NCT06370715 / Recruiting临床4期

A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.
The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

开始日期2024-04-18

申办/合作机构

Eli Lilly & Co.

[+1]

NCT06251635 / RecruitingN/AIIT

Effects of Antipsychotics on Brain Insulin Action in Females: A Randomised Placebo-Controlled, Crossover Multi-Modal Neuroimaging Study

Females treated with antipsychotics have higher rates of comorbid metabolic syndrome than males. Despite this, females have historically been excluded from many mechanistic studies due to confounding effects of menstrual cycles. Recent evidence suggests that brain insulin resistance may be an underlying mechanism through which antipsychotics may exert their metabolic side effects. This study seeks to investigate how brain insulin action differs in females according to their menstrual cycle phase, and how a high metabolic liability agent such as olanzapine might interrupt these differential insulin effects. Young healthy females will be given olanzapine and intranasal insulin to test how these treatment combinations change brain processes. Participants will be tested during both the first half of their menstrual cycle (follicular phase) and the second half of their cycle (luteal phase). We predict that intranasal insulin will change MRI-based measures in females, in a comparable way to males, in the follicular phase only. Adding olanzapine will block these effects of insulin in females in the follicular phase. This investigation has the potential to generate new knowledge in an area of significant unmet need. Demonstrating that antipsychotics disrupt brain insulin action, evidenced by inhibition of recognized effects of insulin on neuroimaging measures, will provide novel insights into currently poorly understood mechanisms.

开始日期2024-02-28

申办/合作机构

Centre for Addiction & Mental Health

100 项与赖脯胰岛素相关的临床结果

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100 项与赖脯胰岛素相关的转化医学

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100 项与赖脯胰岛素相关的专利（医药）

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1,206

项与赖脯胰岛素相关的文献（医药）

2024-01-01·Journal of mass spectrometry : JMS

Chromatographic–mass spectrometric analysis of peptidic analytes (2–10 kDa) in doping control urine samples

Article

作者: Thevis, Mario ; Walpurgis, Katja ; Thomas, Andreas

Abstract:

Peptides with a molecular mass between 2 and 10 kDa that are prohibited in elite sports usually require dedicated sample preparation and mass spectrometric detection that commonly cannot be combined with other (lower molecular mass) substances. In most instances, the physicochemical differences are too significant to allow for a generic analytical procedure. A simplification of established and comparably complex analytical approaches is therefore desirable and has been accomplished in the context of this study. With urine samples representing still the most frequently collected doping control specimens, efficient extraction of peptidic analytes from this matrix was a major goal of this method, as demonstrated for the included compounds such as insulins (human, lispro, aspart, glulisine, tresiba, glargine metabolite, bovine insulin, porcine insulin), growth hormone‐releasing hormones (sermorelin, CJC‐1295, tesamorelin) incl. their respective metabolites, insulin‐like‐growth factors (long‐R3‐IGF‐I, R3‐IGF‐I, des1–3‐IGF‐I), synacthen, gonadorelin and mechano growth factors (human MGF, MGF‐Goldspink). Sample preparation and detection are controlled by five internal standards, covering all five included peptide drug categories. Nearly all requirements of the recent technical documents from the World Anti‐Doping Agency (WADA) considering their minimum required performance levels (MRPL) are fulfilled, and the method was validated for its utilisation as initial testing procedure in doping controls. Finally, the approach was applied to authentic post‐administration study urine samples (for insulins and gonadorelin) in order to provide proof of principle.

2024-01-01·Journal of diabetes and its complications

Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials

Article

作者: Liao, Birong ; Dellva, Mary Anne ; Piras de Oliveira, Carolina ; Chang, Annette M ; Bue-Valleskey, Juliana

AIMS:

To investigate contributions of changes in fasting plasma glucose (FPG) and postprandial glucose (PPG) to changes in hemoglobin A1c (HbA1c) and time-in-range (TIR, 70-180 mg/dL) in people with type 1 diabetes (T1D) and type 2 diabetes (T2D) treated with multiple daily injections (MDI) of insulin lispro (rapid/ultra-rapid formulations).

METHODS:

Multivariate regression models were used to quantify the contributions of FPG and PPG reductions to change in HbA1c and TIR using data from the PRONTO-T1D (N = 1222) and PRONTO-T2D (N = 673) clinical trials. TIR was derived from 10-point self-monitored blood glucose (SMBG) profiles overall, as well as from continuous glucose monitoring (CGM) in the PRONTO-T1D CGM substudy (n = 269/1222).

RESULTS:

A 1 mmol/L FPG reduction corresponded with a 0.09-0.12 % (95 % confidence interval [CI] 0.06-0.15 %) HbA1c reduction in PRONTO-T1D and 0.17-0.26 % (95 % CI 0.13-0.30 %) in PRONTO-T2D (both p < 0.0001). A 1 mmol/L PPG reduction corresponded with a 0.05-0.09 % (95 % CI 0.01-0.12 %) HbA1c reduction in PRONTO-T1D (p < 0.001) and 0.10-0.15 % (95 % CI 0.05-0.19 %) in PRONTO-T2D (p < 0.0001). Reductions in FPG and PPG were significantly associated with increased TIR whether derived from SMBG (7.87-12.95 % [95 % CI 6.81-14.23 %]; all p < 0.0001) or CGM (3.35-4.18 % [95 % CI 2.11-5.39 %]; all p < 0.05).

CONCLUSIONS:

FPG and PPG significantly impact HbA1c and TIR. Balanced management of both FPG and PPG is important to achieve glycemic goals for people with diabetes on MDI insulin therapy.

CLINICAL TRIALS REGISTRATION:

PRONTO-T1D ClinicalTrials.gov identifier: NCT03214367; PRONTO-T2D ClinicalTrials.gov Identifier: NCT03214380.

2024-01-01·Diabetes, obesity & metabolism

Ultra‐rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double‐blind phase 3 study

Article

作者: Pérez Manghi, Federico ; García-Hernández, Pedro ; Liu, Wei ; Wang, Guixia ; Yan, Xiang ; Zhou, Zhiguang ; Feng, Qiong ; Xu, Jianwei ; Ma, Jianhua ; Yuan, Yuan

Abstract:

Aims:

To investigate the efficacy and safety of ultra‐rapid lispro (URLi) versus insulin lispro in predominantly Chinese patients with type 1 diabetes (T1D) in a prospective, randomized, double‐blind, treat‐to‐target, phase 3 study.

Materials and Methods:

Following a lead‐in period, during which insulin glargine U‐100 or insulin degludec U‐100 was optimized, patients were randomly assigned (1:1) to URLi (n = 176) or insulin lispro (n = 178). The primary objective was to test the noninferiority of URLi to insulin lispro in glycaemic control (noninferiority margin = 0.4% for glycated haemoglobin [HbA1c] change from baseline to week 26), with testing for the superiority of URLi to insulin lispro with regard to 1‐ and 2‐hour postprandial glucose (PPG) excursions during a mixed‐meal tolerance test and HbA1c change at week 26 as the multiplicity‐adjusted objectives.

Results:

From baseline to week 26, HbA1c decreased by 0.21% and 0.28% with URLi and insulin lispro, respectively, with a least squares mean treatment difference of 0.07% (95% confidence interval −0.11 to 0.24; P = 0.467). URLi demonstrated smaller 1‐ and 2‐hour PPG excursions at week 26 with least squares mean treatment differences of −1.0 mmol/L (−17.8 mg/dL) and −1.4 mmol/L (−25.5 mg/dL), respectively (p < 0.005 for both) versus insulin lispro. The safety profiles of URLi and insulin lispro were similar.

Conclusions:

In this study, URLi administered in a basal‐bolus regimen demonstrated superiority to insulin lispro in controlling PPG excursions, with noninferiority of HbA1c control in predominantly Chinese patients with T1D.

161

项与赖脯胰岛素相关的新闻（医药）

2024-06-18

·PRNewswire

Gan & Lee Pharmaceuticals to Present Groundbreaking Data on Three Innovative Products at the American Diabetes Association's 84th Scientific Sessions

A phase 1b/2a trial evaluated once- and bi-weekly GZR18, a novel GLP-1 analog, in Chinese subjects with obesity/overweight Pre-clinical studies evaluated the molecular and pharmacological properties of GZR4, an investigational once-weekly insulin analog Pre-clinical studies evaluated and characterized an ultra-long-acting basal insulin, GZR33, and its premixed formulation GZR101 BRIDGEWATER, N.J., June 17, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Shanghai Stock Exchange: 603087) announced today the presentation of three abstracts featuring their investigational products at the American Diabetes Association's (ADA's[1]) 84th Scientific Sessions. The meeting will be held in-person and virtually from June 21-24, 2024, in Orlando, Florida . All abstracts will be published on the journal Diabetes® website. Data from the selected studies will be presented live on June 22, from 12:30-1:30 PM EDT in the Poster Hall. The above abstracts and presentations represent the data that will be showcased or published by Gan & Lee. This press release includes forward-looking statements regarding investigational products currently in development by Gan & Lee. It is important to note that there are risks associated with drug development, and there is no guarantee that future studies will produce results consistent with those presented at the ADA's 84th Scientific Sessions. References: [1]. ADA's 84th Scientific Sessions. [2]. Zhang M, Zhang Y, Peng X, et al. GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models. Eur J Pharmacol. 2022;928:175107. doi:10.1016/j.ejphar.2022.175107 About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®).In China's second Volume Based Procurement (VBP) in 2024, Gan & Lee Pharmaceuticals ranked second overall and first among domestic companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. Further Information [email protected]（Media） [email protected]（Business Development） SOURCE Gan & Lee Pharmaceuticals

上市批准

2024-06-09

·蒲公英Ouryao

【出海新进展】四药企分别出口欧洲、非洲等地

来源：企业公告编辑：wangxinglai2004 近日，4药企分别发布了产品海外上市进展公告，具体为甘李药业通过EMA上市前GMP检查、常山药业制剂获马里注册证书、国药现代API获CEP证书和东亚药业API获韩国注册证书。甘李药业通过EMA检查一、药物基本情况 1. 企业名称：甘李药业股份有限公司 2. 生产地址：北京市通州区漷县镇南凤西一路8号 3. 检查类别：批准前GMP检查（Pre-approval GMP inspection） 4. 涉及产品：甘精胰岛素注射液、赖脯胰岛素注射液、门冬胰岛素注射液 5. 检查车间：A3生产车间、A2库房、A4库房 6. 检查结论：通过批准前检查二、药物其他相情况甘精胰岛素注射液、赖脯胰岛素注射液、门冬胰岛素注射液三款生物类似药分别于2023年8月、10月先后收到欧洲EMA上市许可申请获得受理的通知； 2024 年3月，EMA调查员团队对甘李药业位于北京市通州区厂区内的生产设施进行了为期5天的现场检查；2024年5月，通过EMA上市批准前GMP检查。常山药业制剂获马里注册证书一、药物基本情况药品名称：依诺肝素钠注射液剂型：注射剂规格：0.4mL: 4000AXaIU、0.6mL: 6000AXaIU 药品生产企业：河北常山生化药业股份有限公司批准日期：2024年5月21日有效期：5年二、药物其他相情况依诺肝素钠注射液用于预防静脉血栓栓塞性疾病（预防静脉内血栓形成），特别是与骨科或普外手术有关的血栓形成；治疗已形成的深静脉栓塞，伴或不伴有肺栓塞，临床症状不严重，不包括需要外科手术或溶栓剂治疗的肺栓塞；与阿司匹林合用，治疗不稳定性心绞痛及非Q波心肌梗死；用于血液透析体外循环中，防止血栓形成。国药现代API获CEP证书一、药物基本情况药品名称：Ampicillin Trihydrate/氨苄西林剂型：原料药药品持有人/生产商：国药集团威奇达药业有限公司证书编号：CEP 2022-507 - Rev 00 发证机构：欧洲药品质量管理局（EDQM）二、药物其他相情况氨苄西林主要用于敏感菌所致的泌尿系统、呼吸系统、胆道、肠道感染以及脑膜炎、心内膜炎等。目前，氨苄西林原料药国内主要生产厂商除国药威奇达外，还有华北制药集团先泰药业有限公司、联邦制药（内蒙古）有限公司、珠海联邦制药股份有限公司等。东亚药业API获韩国注册证书一、药物基本情况制造企业名称：浙江东邦药业有限公司企业地址：中国浙江省台州市临海市杜桥镇医化园区产品名称：头孢克洛 DMF注册号：20091125-20-A-229-14(A) 发证机构：韩国食品药品监督管理局（韩国MFDS）二、药物其他相情况头孢克洛为第二代头孢类抗菌药物，可用于治疗敏感菌引起的多种呼吸道感染、泌尿道感染、耳鼻科感染和皮肤及软组织感染等，2021年我国头孢克洛制剂市场销售额约为26.41亿元。

生物类似药上市批准临床1期

2024-05-25

·药时代

「周制剂」降糖时代，GLP-1仍有“盲区”

点击预约直播，观看FDA关于诺和诺德周制剂胰岛素的建议！正文共：2915字 4图预计阅读时间：10分钟2024年5 月 21 日，礼来的替尔泊肽注射液（商品名：穆峰达 ®）获NMPA批准上市，用来改善接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病（T2DM）患者。替尔泊肽由礼来自主研发，是全球首款GLP-1/GIP双靶点受体激动剂，为每周一次皮下注射，早先已被FDA批准降糖和减重两大适应症。此次，替尔泊肽在国内获批上市，周制剂降糖药队伍又添一员猛将。此前，NMPA已经批准包括司美格鲁肽注射液（诺和泰®，诺和诺德）、注射用艾塞那肽微球（百达扬，三生制药）、度拉糖肽注射液（度易达，礼来）、聚乙二醇洛塞那肽注射液（孚来美，豪森药业）、琥珀酸曲格列汀片（DPP-4抑制剂，科伦药业）等在内的周制剂降糖药。从上述产品不难看出，大部分周制剂降糖产品仍是GLP-1类药物。近年来，市场对GLP-1类产品的热情难止，原因在于其表现出的在降糖、减重、心血管疾病及其他一系列慢性疾病或精神类疾病中的积极信号。但是如果单论降糖，GLP-1类药物的整体实力还是不及胰岛素。01胰岛素：最直接，最有效的降糖方式首先，从降糖机制上来讲，GLP-1（胰高血糖素样肽-1）是由肠道L细胞分泌的一种激素，主要通过促进胰岛素分泌、抑制胰高血糖素释放、减缓胃排空和减少食欲等方式达到降低血糖的功效。目前全球范围内上市的GLP-1RA类降糖药主要采用皮下注射和口服两种给药方式。而胰岛素则属于简单粗暴的“直接派”，一般是通过注射（主要是皮下注射，也有特殊情况可采用肌肉/静脉注射）的方式，补充或替代患者体内缺失的胰岛素，直接调节血糖水平。相比之下，胰岛素的适用范围更广，是需要严格控制血糖的1型糖尿病患者以及部分重度2型糖尿病患者的第一选择。尤其是对于本身不能正常分泌胰岛素的1型糖尿病（T1DM）患者而言，其日常的血糖控制通常采用每日多次注射或使用胰岛素泵的方式。事实上，目前获批的GLP-1RA类降糖药也主要被被批准用于T2DM患者。但也有研究表明，对于仍残留有部分β细胞功能的T1DM患者，GLP-1RA联合胰岛素可能有望实现更理想的血糖控制。从理论上讲，GLP-1RA之于T1DM患者虽有可能辅助改善血糖控制，但并不能完全替代胰岛素治疗。此外，并非所有T2DM患者均能使用GLP-1类药物。除了一般的过敏情况，包括糖尿病酮症酸中毒患者、有甲状腺髓样癌病史或家族史的患者，以及一些患有消耗性疾病（结核、肿瘤等）的患者均不能使用GLP-1类药物。对于上述这类患者，GLP-1RA的使用或将带来其他风险，胰岛素仍是最有效的选择。再者，个体差异决定了一部分人需要更精细的血糖管理，比如对于需要餐时剂量调整或面临复杂血糖波动的患者，相比于GLP-1RA，胰岛素能提供更加灵活和精准的治疗方案。02礼来公布III期临床积极数据据悉，胰岛素周制剂的应用预计为患者每年减少胰岛素注射约300余次，将使患者依从性大大改善。但目前全球范围内尚未有胰岛素周制剂产品获批上市。在礼来的替尔泊肽国内上市之前，这家公司还公布另一个值得关注的消息——胰岛素周制剂efsitora alfa（efsitora）在两项III期研究（QWINT-2和QWINT-4）中均达到主要终点。QWINT-2（NCT05362058）研究共入组928名未经胰岛素治疗的T2DM成人患者。试验中，受试者被随机分配到美国、巴西、加拿大、中国、捷克共和国、德国、希腊、日本、韩国、墨西哥和波多黎。其中，试验组每周一次注射efsitora，对照组每日一次注射德谷胰岛素（诺和诺德）。试验的主要终点是，52周时efsitora降低糖化血红蛋白（A1C，可反映过去2-3个月内患者平均血糖控制的情况，一般要求数值在7%或更低）的效果不亚于德谷胰岛素。且试验中纳入了部分使用GLP-1类药物的患者，因此也将评估efsitora在这部分患者中的治疗效果。结果显示，52周时，efsitora降低了1.34%的A1C（6.87%<7%），德谷胰岛素降低了1.26%的A1C（6.95%<7%）。且针对使用/不使用GLP-1类药物的患者，efsitora表现出并不逊色于德谷胰岛素的降低A1C的能力。QWINT-4（NCT05462756）研究共入组730名此前已接受基础胰岛素治疗且每天至少两次餐时胰岛素注射的T2DM成人患者。试验中，受试者被随机分配到美国、阿根廷、德国、印度、意大利、墨西哥、波多黎各和西班牙。其中，试验组治疗方案为：每周一次注射efsitora+赖脯胰岛素（速效胰岛素，通常在餐前使用，有效时间约2~5h），对照组治疗方案为：每日一次甘精胰岛素（赛诺菲）+赖脯胰岛素。试验的主要终点是，26周时efsitora降低A1C的效果不亚于甘精胰岛素。结果显示，26周时，efsitora降低了1.07%的A1C（7.12%），甘精胰岛素同样降低了1.07%的A1C（7.11%），试验达到主要终点。安全性方面，以目前长效胰岛素最普遍也是最难解决的低血糖事件（血糖 <54 mg/dL）发生率来讲，efsitora vs 德谷胰岛素（0.58 vs 0.45），efsitora vs 甘精胰岛素（6.6 vs 5.9），均略高于对照组，但差距并不大。根据礼来官方披露信息，efsitora整个注册性QWINT研究共纳入了五项试验，在今年的欧洲糖尿病研究学会（EASD）年会上（预计9/10月举行）将公布另外三项QWINT-1、QWINT-3和QWINT-5的主要结果和QWINT-2的更多详细结果。其中预估将包括针对T1DM患者数据。目前来看，efsitora的数据可圈可点，那其是否会是全球第一个上市的周制剂胰岛素？03诺和诺德领先深耕胰岛素领域多年的诺和诺德在胰岛素周制剂上又一次领先。美国东部时间2024年5月24日，FDA召开内分泌学和代谢药物咨询委员会，会议的主要议题是：讨论诺和诺德提交的NNC0148-0287注射液（insulin icodec，周制剂胰岛素）的BLA（761326）申请的安全性和有效性。根据诺和诺德官网信息，icodec 的注册性ONWARDS 研究共由6项研究组成。其中，ONWARDS 1~5仅纳入了T2DM患者，ONWARDS 6仅纳入T1DM患者。图片来源：FDA官网此次FDA会议主要围绕ONWARDS 6 研究展开。资料显示，ONWARDS 6共纳入582名T1D患者，试验组患者治疗方案为：每周一次icodec +门冬胰岛素（速效胰岛素，用于餐后血糖控制），对照组患者治疗方案为：每日一次德谷胰岛素+门冬胰岛素。图片来源：FDA官网对于试验结果的有效性，FDA认为26周时icodec组的整体疗效的确与德谷胰岛素组相当，但52周时的结果显示德谷胰岛素组更胜一筹。但无疑的是icodec组在26周、52周时均显著降低了AIC。图片来源：FDA官网目前，FDA对于ONWARDS 6 的质疑主要集中在安全性方面。FDA简报文件中指出，在ONWARDS 6 研究中，与德谷胰岛素组相比，icodec 组的2/3级低血糖事件发作率显著更高。事实上，低血糖事件是外源性胰岛素使用中最大的限制因素，这不只局限于ONWARDS 6研究。Marc-Andre Cornier博士（Medical University of South Carolina大学医学教授）曾在国外媒体VERY WELL的采访中提到：“在使用胰岛素的过程中，注射过量胰岛素的情况并不罕见。周制剂胰岛素的潜在缺点在于短期内更难进行调整，因为这种制剂在体内作用时间很长。如果要使用周制剂胰岛素，建议提供连续血糖监测。”在此次FDA会议上，诺和诺德也提出了相应措施，即在icodec的标签中标识低血糖风险，并要求医院/医师将其仅应用于使用连续血糖监测设备/血糖变异性低的那一部分患者。从多方面信息来看，诺和诺德的这款周制剂胰岛素被FDA批准上市的希望还是很大的，但是否能一下子覆盖到T1DM和T2DM所有患者还有待考量。目前，诺和诺德的这款周制剂胰岛素已通过CHMP（欧洲药品管理局人用药品委员会）的首肯，被其推荐上市用于T2DM患者的血糖控制（基于ONWARDS 3研究，这项研究仅纳入T2DM患者）。在2024年3月21日发布的公告中，诺和诺德表示预计这款产品将在大约两个月内获得欧盟委员会的最终上市授权。图片来源：诺和诺德官网小结对于广大的慢性病患者人群而言，用药需求已经由“有药可用”上升到“需要更长效，更有效的药”。周制剂胰岛素需要解决的问题还有不少，但是若能成顺利上市，必然是降糖领域的又一里程碑。参考资料：1.Lilly Releases Promising Clinical 3 Trial Results for Once-Weekly Insulin (verywellhealth.com)2.各公司官网3.FDA官网4.其他公开资料封面图来源：pixabay版权声明/免责声明本文为药时代原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn一款药物撑起4笔BD，三个经手药企均被并购！2.25亿美元背后，不容忽视的自免风潮398:1！药企CEO与员工薪酬差距TOP 9点击阅读原文，了解更多！

上市批准临床结果

100 项与赖脯胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04477	赖脯胰岛素	A10AB04 A10AD04 A10AC04	DB00046

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
糖尿病	欧盟	Eli Lilly Nederland BV	1996-04-30
糖尿病	冰岛	Eli Lilly Nederland BV	1996-04-30
糖尿病	列支敦士登	Eli Lilly Nederland BV	1996-04-30
糖尿病	挪威	Eli Lilly Nederland BV	1996-04-30

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
高血糖	临床3期	美国	Eli Lilly & Co.	2011-03-01
1型糖尿病	临床3期	中国	Eli Lilly & Co.	2005-03-01
2型糖尿病	临床3期	墨西哥	Eli Lilly & Co.	2002-11-01

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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


NCT04200313 (CTgov)	N/A	1型糖尿病	440	Usual Care (UC)	醖夢遞醖繭鏇範鹹願製(襯鑰齋襯醖築餘膚壓構) = 鏇顧網憲夢襯築鏇窪憲蓋餘顧積艱壓鏇糧齋遞 (鑰觸築膚簾繭壓繭襯繭, 積鑰憲艱鏇淵繭襯襯鬱 ~ 獵淵淵壓選選築廠製觸) 更多	-	2023-11-07
NCT05067270 (CTgov)	临床1期	注射部位反应 \| 1型糖尿病	40	insulin+magnesium chloride+treprostinil+sodium citrate+humalog (Treatment Given to Arm Region)	製窪顧窪蓋網簾鏇衊糧(獵憲壓醖艱鏇鏇鬱憲衊): Geometric Least Squares Mean Ratio = 1.77 (95.0% CI, 1.3 ~ 2.4); Geometric Least Squares Mean Ratio = 1.49 (95.0% CI, 1.09 ~ 2.02); Geometric Least Squares Mean Ratio = 1.49 (95.0% CI, 1.1 ~ 2.03)	-	2023-10-04
				insulin+magnesium chloride+treprostinil (Treatment Given to Thigh)
NCT05262387 (EASD2023)	临床1期	-	-	Ultra rapid lispro (URLi)	鹽艱鹹齋窪範鹽淵繭蓋(壓憲鹽窪蓋鹽遞選製範) = 築艱觸糧觸製鹹選醖築繭壓鹽築網襯願鏇獵壓 (淵鑰願顧鹽淵鹽選鏇構 )	积极	2023-10-03
				Lispro	鹽艱鹹齋窪範鹽淵繭蓋(壓憲鹽窪蓋鹽遞選製範) = 鏇築夢觸構鬱齋積齋鑰繭壓鹽築網襯願鏇獵壓 (淵鑰願顧鹽淵鹽選鏇構 )
NCT04605991 (Pubmed)	临床3期	2型糖尿病	176	Ultra rapid lispro (URLi)	窪顧積壓願積膚醖鏇淵(鏇壓繭觸製糧醖膚選艱) = 餘鑰獵衊艱襯製顧鹽鹹鏇壓夢廠鹽廠淵選艱蓋 (膚餘築鹹襯蓋醖醖願構 ) 更多	-	2023-04-07
NCT04605991 (CTgov)	临床3期	2型糖尿病	187	Insulin Glargine+LY900014	壓齋範窪鏇鏇鏇壓鏇願(鹹蓋夢觸積鹽艱繭願鏇) = 範糧簾築鬱衊簾夢齋壓壓夢鹽醖簾糧夢積積膚 (鬱繭構積簾鬱襯網網觸, 鑰襯願艱膚鏇壓鹽選範 ~ 餘蓋鏇遞選範齋襯廠衊) 更多	-	2023-03-03
NCT03952130 (CTgov)	临床3期	1型糖尿病	354	insulin glargine+Insulin Degludec+Insulin Lispro (Insulin Lispro (Humalog))	糧餘選觸積膚壓鹹繭獵(醖鑰襯範壓顧襯壓糧繭) = 遞選積蓋蓋範鏇製繭範製鏇遞繭願艱鑰構製製 (廠廠積襯獵壓淵鹽蓋獵, 衊鏇繭窪鑰築顧艱願築 ~ 壓積憲積蓋襯願觸淵膚) 更多	-	2023-02-08
				insulin glargine+Insulin Degludec+LY900014 (LY900014)	糧餘選觸積膚壓鹹繭獵(醖鑰襯範壓顧襯壓糧繭) = 積憲築積築壓簾餘範夢製鏇遞繭願艱鑰構製製 (廠廠積襯獵壓淵鹽蓋獵, 鏇衊醖餘製範窪簾壓夢 ~ 壓衊膚遞憲餘壓夢網顧) 更多
NCT03262116 (CTgov)	临床2/3期	1型糖尿病	20	Insulin (Insulin-only Bionic Pancreas With BC222 Lispro)	餘襯繭艱衊遞獵艱齋鹽(糧壓鑰壓夢網憲壓網鬱) = 選醖廠築積窪願襯顧構鹽憲夢憲壓鹽繭艱淵選 (觸鏇觸範獵淵餘鹹蓋遞, 膚網願壓網窪鬱鏇願構 ~ 鬱廠簾製蓋鹽遞鬱膚艱) 更多	-	2022-12-09
				Insulin (Insulin-only Bionic Pancreas With Insulin Lispro)	餘襯繭艱衊遞獵艱齋鹽(糧壓鑰壓夢網憲壓網鬱) = 鹽鏇繭鹽遞獵窪糧簾積鹽憲夢憲壓鹽繭艱淵選 (觸鏇觸範獵淵餘鹹蓋遞, 獵艱遞齋範窪廠衊築夢 ~ 窪憲鹽窪鹹簾淵壓鏇觸) 更多
NCT03214380 (PRONTO-T2D, Pubmed)	临床3期	2型糖尿病	933	Ultra-rapid lispro	範糧簾獵鹹鬱繭製廠製(醖願構遞窪獵夢築願艱) = 積糧鬱鑰範觸憲衊選窪廠鹹鏇憲獵糧鑰範築壓 (憲廠繭夢願遞製夢夢積 )	积极	2022-07-04
				Lispro (Humalog®)	範糧簾獵鹹鬱繭製廠製(醖願構遞窪獵夢築願艱) = 鏇簾鹹窪鏇窪遞醖醖範廠鹹鏇憲獵糧鑰範築壓 (憲廠繭夢願遞製夢夢積 )
NCT01613807 (CTgov)	临床4期	妊娠期糖尿病	40	insulin lispro (Mix 50/50)	鏇鹽鹽醖鹽糧觸襯衊醖(築淵夢淵壓選鏇憲醖鬱) = 糧願淵簾鏇積廠壓願鬱遞醖齋壓觸鑰襯願蓋襯 (齋鏇觸廠淵蓋鹽獵鏇鹽, 餘窪壓製獵遞遞餘繭選 ~ 製廠餘製願襯築積鏇繭) 更多	-	2022-06-08
				Insulin (Usual Insulin Regimen)	鏇鹽鹽醖鹽糧觸襯衊醖(築淵夢淵壓選鏇憲醖鬱) = 築網範獵糧遞窪遞齋獵遞醖齋壓觸鑰襯願蓋襯 (齋鏇觸廠淵蓋鹽獵鏇鹽, 膚製簾餘憲構窪窪獵夢 ~ 衊鹹鏇範醖膚齋夢廠淵) 更多
NCT04585776 (CTgov)	临床2期	1型糖尿病	31	Insulin Degludec+LY900014	顧顧觸糧膚廠窪鬱鹽艱(艱蓋獵襯積範遞憲顧窪) = 選憲鹽壓醖遞鑰築鹽餘廠鑰積築鏇製淵鏇蓋範 (憲艱鬱廠窪構醖觸壓壓, 顧範齋鹽繭鏇觸鑰餘糧 ~ 簾齋鑰願淵鏇蓋選簾鑰) 更多	-	2022-06-03