EFFICACY OF EARLY GLARGINE PLUS STANDARD IV INSULIN VERSUS STANDARD IV INSULIN IN PATIENTS WITH DIABETIC KETOACIDOSIS: A RANDOMISED CONTROLLED TRIAL - NIL

开始日期2024-09-30

申办/合作机构-

NCT06881264

/ Active, not recruiting临床3期

A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)

The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents

开始日期2024-04-29

申办/合作机构

江苏恒瑞医药股份有限公司

NCT06340854

/ Active, not recruiting临床3期

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

开始日期2024-04-19

申办/合作机构

Novo Nordisk A/S

100 项与甘精胰岛素相关的临床结果

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100 项与甘精胰岛素相关的转化医学

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100 项与甘精胰岛素相关的专利（医药）

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3,320

项与甘精胰岛素相关的文献（医药）

2025-05-01·DIABETES OBESITY & METABOLISM

Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin‐naive adults with suboptimally controlled type 2 diabetes

Article

作者: Dex, Terry ; Meneghini, Luigi ; Polonsky, William H. ; Rodrigues, Amélie ; Shah, Viral N.

Abstract:

Aims:

In Soli‐CGM, treatment with iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL) in insulin‐naive adults with suboptimally controlled type 2 diabetes (T2D; haemoglobin A1c 9%–13% on ≥2 oral antihyperglycaemic agents (OADs) ± glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) therapy) increased time in range (TIR; primary endpoint) from 26.4% at baseline to 52.7% at Week 16. This exploratory analysis examined the impact of treatment with iGlarLixi on patient‐reported treatment satisfaction.

Materials and Methods:

Soli‐CGM was a single‐arm, 16‐week, multicentre, interventional, open‐label, phase 4 study using blinded continuous glucose monitoring (CGM; FreeStyle Libre Pro) to assess glycaemic metrics (N = 124). CGM data were collected for a 2‐week period before initiation of iGlarLixi, and after treatment with iGlarLixi (Weeks 14–16). Treatment satisfaction was assessed using the Diabetes Medication Treatment Satisfaction Tool (DM‐SAT, which comprises four domains: well‐being, medical control, lifestyle and convenience), at baseline and end‐of‐treatment. Association of TIR and overall satisfaction (sum of all items) was also assessed.

Results:

Overall, 118 (95.9%) and 107 (87.0%) participants completed the DM‐SAT at baseline and Week 16, respectively. Mean overall score increased by 0.18, from 0.59 (baseline) to 0.78 (Week 16). A trend in improvement in score was observed in all domains. Improvement in TIR had a positive, but weak, trend of association with improvement in overall treatment satisfaction (mean r = 0.14).

Conclusions:

In people with T2D suboptimally controlled on ≥2 OADs ± GLP‐1 RA, 16 weeks' treatment with iGlarLixi resulted in a trend of improvement in treatment satisfaction.

2025-05-01·Value in Health Regional Issues

Cost-Effectiveness Analysis of Pharmacological Treatment With Insulin and Insulin Analogs for Type 1 and Type 2 Diabetes Mellitus in Colombia

Article

作者: Arango, Luz Karime Osorio ; Ibáñez, Diego Fernando Ávila ; Ramirez, Luis Esteban Orozco ; Plazas, Merideidy ; Escobar, Ivan Darío ; Morales, Christian Camilo Anzola

OBJECTIVES:

This study aimed to estimate the cost-effectiveness relationship of insulins and insulin analogs in diabetes mellitus type 1 (DM1) and 2 (DM2), from the perspective of the Colombian health system.

METHODS:

A short-term decision tree model (SM) was built, the outcome of which was severe/nocturnal hypoglycemia, and a long-term Markov model for quality-adjusted life-years. The probabilities were calculated through a literature review of effectiveness and safety. The costs are estimated from official databases. Deterministic and probabilistic sensitivity analyses were performed.

RESULTS:

For DM1, in prandial insulins, and for both models, the cost-effective interventions (CEIs) are aspartate and lispro. In basal insulins, the CEIs are NPH and glargine U-100 in both models. In the comparison of detemir and NPH, detemir generates lower nocturnal hypoglycemia and higher quality-adjusted life-years; however, in the long-term Markov model, the incremental cost-effectiveness ratio exceeds the threshold. For DM2, in the prandial insulin, and for both models, aspartate is a CEI and the glargine U-300 is also a CEI in the SM. In basal insulin, the CEIs are glargine U-100 and detemir (for nocturnal hypoglycemia) in both models and glargine U-300 is also a CEI in the SM. Finally, in the group of combinations, iGlarLixi is dominant over IDegLira.

CONCLUSIONS:

The results favor the use of analog insulins over human insulins, the former reducing the possibility of acute events and chronic complications to a greater extent.

2025-05-01·DIABETES OBESITY & METABOLISM

iGlarLixi provides improved early glycaemic control after 12 weeks of treatment compared with basal insulin in Asian people with type 2 diabetes: A post hoc analysis of the LixiLan‐O‐AP and LixiLan‐L‐CN studies

Article

作者: Du, Qin ; Huang, Shan ; Zhang, Yawei ; Lauand, Felipe ; Yuan, Xiaoyong ; Song, Lulu ; Guo, Xiaohui ; Zhang, Jie ; Yang, Wenying ; Kang, Lei ; Wang, Zhini

Abstract:

Aims:

To evaluate early glycaemic control (glycated haemoglobin [HbA1c] < 7.0% [<53.0 mmol/mol], fasting plasma glucose [FPG] ≤ 7.0 mmol/L or postprandial glucose [PPG] ≤ 10.0 mmol/L) with iGlarLixi versus insulin glargine 100 U/mL (Gla‐100) in Asian people with suboptimally controlled type 2 diabetes (T2D) on oral antidiabetic drugs (OADs) in LixiLan‐O‐AP or basal insulin (BI) ± OADs in LixiLan‐L‐CN.

Materials and Methods:

This post hoc analysis evaluated changes from baseline to Week 12 in HbA1c, FPG and PPG, hypoglycaemia incidence and the rates of target HbA1c achievement at Weeks 8 and 12. Median time to glycaemic control (i.e., time to 50% achieving target HbA1c, FPG or PPG) was also assessed.

Results:

At Week 12, mean HbA1c reductions were greater with iGlarLixi versus Gla‐100 in LixiLan‐O‐AP (−1.6% vs. −1.1% [−17.0 vs. −12.0 mmol/mol]) and LixiLan‐L‐CN (−1.3% vs. −0.5% [−13.9 vs. −5.4 mmol/mol]). PPG reductions were greater with iGlarLixi, while FPG reductions and hypoglycaemia incidence were similar. At Weeks 8 and 12, more participants had achieved target HbA1c or PPG with iGlarLixi versus Gla‐100 in both studies. Median time to achieve HbA1c and PPG targets was shorter with iGlarLixi versus Gla‐100 in LixiLan‐O‐AP (85 vs. 126 days and 84 vs. 167 days) and LixiLan‐L‐CN (85 vs. 239 days and 85 days vs. not estimable); median time to achieve FPG target was similar in LixiLan‐O‐AP (57 vs. 57 days) and LixiLan‐L‐CN (29 vs. 30 days).

Conclusions:

In Asian people with T2D suboptimally controlled on OADs or BI, iGlarLixi provided comprehensive earlier glycaemic control than Gla‐100.

318

项与甘精胰岛素相关的新闻（医药）

2025-04-14

·生物制品圈

探秘生物制药：大肠杆菌的神奇 “制药” 之旅

摘要：自重组 DNA 技术出现以来，大肠杆菌在生物制药领域发挥了重要作用。它具有诸多优势，如遗传背景清晰、生产成本低、产量高，但也存在一些局限性，比如无法进行某些特定的蛋白质翻译后修饰。本文对大肠杆菌生产且经美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准的生物制药进行了综述，涵盖了激素、酶、肽、疫苗、融合蛋白、抗体片段及其他生物制药等类别，介绍了这些药物的治疗用途、生产公司及研发进展等信息。一、大肠杆菌在生物制药中的角色20 世纪 70 年代，随着重组 DNA 技术的出现，大肠杆菌因其能高效且低成本地生产重组蛋白而备受关注。1982 年，由大肠杆菌生产的重组胰岛素获 FDA 批准，这一里程碑事件开启了生物制药的新时代，也为更多重组药物的生产奠定了基础。尽管大肠杆菌在生产复杂蛋白质时存在一定局限，如缺乏某些翻译后修饰能力，但它依然是生物制药中极具吸引力的宿主菌，其遗传特性明确，拥有多种成熟的克隆技术和表达系统（原文 Figure 1，展示在大肠杆菌中生产重组生物制药的一般方法，帮助读者理解生产流程）。二、大肠杆菌生产的各类生物制药1.激素：大肠杆菌在激素生产方面成果丰硕。1982 年，礼来公司生产的重组人胰岛素（Humulin）获 FDA 批准，用于治疗糖尿病。之后，赛诺菲 - 安万特公司生产的长效胰岛素类似物甘精胰岛素（Lantus）、礼来公司的赖脯胰岛素（Lyumjev）等多种胰岛素类似物相继获批。此外，生长激素、干扰素、甲状旁腺激素等多种激素也由大肠杆菌生产并获批用于临床治疗不同疾病。例如，生长激素用于治疗生长激素缺乏症，干扰素用于治疗多种癌症和肝炎，甲状旁腺激素用于治疗骨质疏松症和控制低钙血症等（原文 Table 1，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组激素及其作用机制，使信息更直观）。当下，还有许多新型胰岛素类似物处于临床研究阶段，旨在提升疗效和控制血糖的速度。2.酶：多种治疗用酶也可由大肠杆菌生产。比如，2010 年获批用于治疗慢性痛风的培戈洛酶（Pegloticase），2012 年获批用于降低肾功能受损患者血浆中甲氨蝶呤（MTX）含量的羧肽酶（Voraxaze），2018 年获批用于治疗急性淋巴细胞白血病的培门冬酶（Calaspargase pegol）等（原文 Table 2，呈现经 FDA 和 EMA 批准的大肠杆菌生产的重组酶及其作用机制）。目前，科研人员还在评估大肠杆菌生产的酶在临床应用中的新潜力，期望开发出更有效的治疗药物。3.肽：大肠杆菌生产的肽类生物制药在多种疾病治疗中发挥着重要作用。如用于治疗急性失代偿性心力衰竭的奈西立肽（Natrecor）、治疗生长发育障碍的胰岛素样生长因子 - 1（Increlex）、治疗骨质疏松症的降钙素（Fortical）等（原文 Table 3，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组肽及其作用机制）。这些肽类药物通过与特定受体结合，调节生理过程，从而发挥治疗作用。4.疫苗：在疫苗生产领域，大肠杆菌也有重要贡献。例如，中国研发的重组戊型肝炎疫苗（Hecolin）是全球首个基于病毒样颗粒的戊型肝炎疫苗，由大肠杆菌生产并于 2011 年获批。还有人乳头瘤病毒（HPV）L1 VLPs 疫苗（Cecolin）、针对马链球菌的 Strangvac 疫苗、预防肺炎球菌感染的肺炎球菌结合疫苗等，以及多种脑膜炎球菌疫苗如 Trumenba 和 Bexsero 等，均由大肠杆菌生产并获批用于人类或动物疾病的预防（原文 Table 4，列举经 FDA 和 EMA 批准的大肠杆菌生产的重组疫苗）。此外，还有一些基于大肠杆菌生产的疫苗正处于研发阶段。5.融合蛋白和抗体片段：许多融合蛋白和抗体片段类生物制药由大肠杆菌生产并获批用于治疗多种疾病。例如，用于治疗年龄相关性黄斑变性的雷珠单抗（Ranibizumab）及其生物类似药 Byooviz 和 Susvimo，治疗 HER2 阳性乳腺癌的曲妥珠单抗（虽最初在仓鼠卵巢细胞生产，但也有在大肠杆菌生产的相关研究），治疗克罗恩病和类风湿关节炎的赛妥珠单抗（Certolizumab pegol）等（原文 Table 5，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组抗体和融合蛋白及其作用机制）。近年来，还有多种在研的大肠杆菌生产的抗体和融合蛋白处于不同临床研究阶段，用于治疗癌症等疾病。6.其他生物制药：除上述类别外，大肠杆菌还用于生产其他多种生物制药。如用于治疗中性粒细胞减少症的非格司亭（Filgrastim）及其聚乙二醇化形式（Neulasta），治疗软组织肉瘤的他索纳明（Beromun），治疗类风湿关节炎的阿那白滞素（Anakinra）等。这些药物在各自的治疗领域发挥着重要作用，为患者提供了有效的治疗选择。三、总结与展望大肠杆菌在生物制药领域具有重要地位，凭借其遗传背景清晰、易于操作、生产成本低和产量高等优势，生产出了众多经 FDA 和 EMA 批准的生物制药，广泛应用于多种疾病的治疗。尽管它存在无法进行某些翻译后修饰等局限性，但随着生物技术的不断发展，这些问题有望得到解决，其在生物制药中的应用潜力将进一步提升。未来，大肠杆菌生产的生物制药可能会在疾病治疗中发挥更重要的作用，占据更大的市场份额。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗微生物疗法

2025-04-13

·蒲公英Ouryao

【出海新进展】4药品出口海外！

来源：企业公告编辑：wangxinglai2004近日，四药企分别发布了产品海外上市进展公告，具体为甘李药业制剂获巴基斯坦注册批件、浙江奥翔药业原料药获CEP证书、健友生化制剂获FDA批件和浙江东邦药业原料药获韩国注册证书。甘李药业制剂获巴基斯坦注册批件一、药物基本情况药品名称：BASAGINE 药品通用名：甘精胰岛素注射液适应症：糖尿病剂型：注射剂规格：3ml：100IU/ml（卡式瓶）批件号：Reg. No. 120504申请人：甘李药业股份有限公司二、药物其他相情况甘精胰岛素注射液属于长效胰岛素类似物产品，又称基础胰岛素类似物，每天注射一次，注射起效后作用时间可持续24小时。甘精胰岛素具有作用时间长、血药浓度无峰值、平稳地降低患者血糖的作用，有较好的疗效和安全性，因此甘精胰岛素注射液成为糖尿病治疗中尤为重要的基础胰岛素类似物。截至公告发布日，在巴基斯坦境内甘精胰岛素注射液的主要供货商为赛诺菲。赛诺菲作为原研厂家，其甘精胰岛素产品2024年的全球销售额约17.6 亿美元，截至2024 年9月30日，甘李药业在甘精胰岛素项目中累计投入研发费用9.06亿元人民币。浙江奥翔药业原料药获CEP证书一、药物基本情况药品名称：盐酸毛果芸香碱剂型：原料药持有人：浙江奥翔药业股份有限公司证书编号：CEP 2023-367-Rev 00 发证机构：欧洲药品质量管理局（EDQM）二、药物其他相情况盐酸毛果芸香碱最早用于治疗口干症，剂型为片剂。随后盐酸毛果芸香碱被开发为其它剂型，如凝胶剂、滴眼液等，用于治疗开角型青光眼、闭角型青光眼以及高眼压症等。 2021年，艾伯维（Abbvie）旗下公司艾尔建研制的盐酸毛果芸香碱滴眼液（规格1.25%）获美国FDA批准上市，是全球首款用于治疗老视的药物。盐酸毛果芸香碱是M-胆碱受体激动剂，可激活平滑肌的毒蕈碱受体，通过虹膜括约肌的收缩，使瞳孔收缩，以增加焦深，改善近中视力，同时保持瞳孔对光的反应，另外其还可收缩睫状肌，增强适应力，从而达到治疗成人老视的效果。健友生化制剂获FDA批件一、药物基本情况药品名称：利拉鲁肽注射液适应症：作为饮食和运动的辅助手段，改善成人和10岁及以上的儿童2型糖尿病患者的血糖控制。降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件的风险。剂型：注射液规格：18 mg/3 mL (6 mg/mL) ANDA号：218115 申请人：南京健友生化制药股份有限公司二、药物其他相情况利拉鲁肽注射液原研药品，由NOVO NORDISK INC持有，2010年01月25日前经FDA批准在美国上市。经查询，除原研厂家以外，美国境内仅有1家HIKMA PHARMACEUTICALS USA INC同规格的利拉鲁肽注射液获批上市。截至目前公司在利拉鲁肽注射液研发项目上已投入研发费用约人民币5,737.31万元。浙江东邦药业原料药获韩国注册证书一、药物基本情况企业名称：浙江东邦药业有限公司地址：中国浙江省台州市临海市台州湾经济技术开发区东海第五大道21号产品名称：头孢妥仑匹酯 DMF注册号：20250326-209-J-1841 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妥仑匹酯为第三代头孢类抗菌药物，用于治疗敏感菌引起的呼吸道、泌尿系统、胆道、皮肤软组织感染等。据相关数据显示，2023年度头孢妥仑匹酯制剂全国销售额约为1.36亿元。

上市批准

2025-04-10

·PipelineReview

Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 10, 2025 I Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: “The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It’s pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly Twitter ): @BioconBiologics and LinkedIn : Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

上市批准免疫疗法

100 项与甘精胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03250	甘精胰岛素	A10AE04	DB00047

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	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	冰岛	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	列支敦士登	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	挪威	Sanofi-Aventis Deutschland GmbH	2000-06-09
1型糖尿病	美国	Sanofi-Aventis U.S. LLC	2000-04-20
2型糖尿病	美国	Sanofi-Aventis U.S. LLC	2000-04-20

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
急性心肌梗塞	临床3期	美国	Sanofi	2008-04-01
急性心肌梗塞	临床3期	阿根廷	Sanofi	2008-04-01
急性心肌梗塞	临床3期	巴西	Sanofi	2008-04-01
急性心肌梗塞	临床3期	加拿大	Sanofi	2008-04-01
急性心肌梗塞	临床3期	墨西哥	Sanofi	2008-04-01
糖尿病昏迷	临床3期	美国	Sanofi	2008-04-01
糖尿病昏迷	临床3期	阿根廷	Sanofi	2008-04-01
糖尿病昏迷	临床3期	巴西	Sanofi	2008-04-01
糖尿病昏迷	临床3期	加拿大	Sanofi	2008-04-01
糖尿病昏迷	临床3期	墨西哥	Sanofi	2008-04-01

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临床结果

适应症

分期

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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


NEWS 人工标引	N/A	2型糖尿病	568	甘精胰岛素U300 (初治)	鑰鏇鏇艱簾願顧製繭繭(範衊壓繭製蓋遞範餘襯) = 願餘獵願齋艱膚繭構窪構憲鬱簾選獵艱網廠遞 (鬱積窪鏇鑰築醖齋鹹願 ) 更多	积极	2024-11-19
				甘精胰岛素U300 (基础胰岛素转换)	鑰鏇鏇艱簾願顧製繭繭(範衊壓繭製蓋遞範餘襯) = 鬱餘簾觸憲淵選襯窪繭構憲鬱簾選獵艱網廠遞 (鬱積窪鏇鑰築醖齋鹹願 ) 更多
NCT03406000 (TOP1, Pubmed)	临床4期	1型糖尿病	-	Twice-daily basal insulin	襯夢鬱窪壓積艱衊齋選(糧願築鏇糧鹽築膚鹹簾) = 製鬱艱鑰蓋簾選廠鏇艱築蓋鏇鑰衊獵鬱顧餘觸 (艱鬱鬱蓋觸壓鬱窪襯範 ) 更多	积极	2024-07-09
ISN WCN2024	N/A	2型糖尿病 \| 终末期肾脏病	11	NPH insulin	觸窪觸獵醖築糧製遞鹽(廠鑰範繭繭遞鑰鬱廠廠) = 積鹽齋艱廠膚鏇鬱醖遞製壓簾窪遞醖壓顧襯選 (網願壓顧繭鏇鑰顧淵夢, ±76.9)	积极	2024-04-01
				Glargine insulin	觸窪觸獵醖築糧製遞鹽(廠鑰範繭繭遞鑰鬱廠廠) = 觸繭製膚膚簾壓醖簾積製壓簾窪遞醖壓顧襯選 (網願壓顧繭鏇鑰顧淵夢, ±60.6)
NCT03703869 (Pubmed \| Diabetes Ther)	N/A	2型糖尿病	412	Insulin Glargine U300 (Gla-300)	憲簾鏇憲憲觸繭獵餘築(築廠齋糧積糧選網壓齋) = PROs improved 齋壓鑰選襯選夢築膚鏇 (膚夢範膚遞選襯壓顧鏇 ) 更多	积极	2024-03-01
NCT01524705 (FLAT-SUGAR, CTgov)	临床4期	2型糖尿病	102	Insulin Glargine+Metformin+Exenatide	艱網齋艱糧艱艱範網繭(鑰遞餘鬱獵淵網襯鹹選) = 願糧廠憲窪憲衊鑰膚製艱範選襯壓積獵願顧艱 (蓋獵襯願壓醖顧憲獵糧, 7.89) 更多	-	2023-12-29
EASD2023	N/A	2型糖尿病	-	Insulin glargine 300 U/mL (Gla-300)	鬱淵餘選遞齋遞蓋衊醖(衊積憲淵繭構壓願壓顧) = 遞鹹衊齋餘築糧衊獵顧膚築壓繭簾衊餘顧願鹹 (構構簾襯廠鹽餘艱構鏇 )	-	2023-10-05
				Long-acting basal insulins (BIs)/NPH insulin	鬱淵餘選遞齋遞蓋衊醖(衊積憲淵繭構壓願壓顧) = 壓觸鏇選襯蓋築積製顧膚築壓繭簾衊餘顧願鹹 (構構簾襯廠鹽餘艱構鏇 )
NCT00069784 (ORIGIN, ESC2023)	临床3期	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	繭鹽齋築積築積衊製製(衊簾蓋繭艱獵夢廠夢鏇) = 衊願選夢膚構醖鹽餘遞醖餘觸獵糧鏇網膚襯淵 (鏇鹹鹽選積糧積製鑰鏇 )	-	2023-08-26
				Glargine	繭鹽齋築積築積衊製製(衊簾蓋繭艱獵夢廠夢鏇) = 窪餘蓋鬱遞選獵選鏇鑰醖餘觸獵糧鏇網膚襯淵 (鏇鹹鹽選積糧積製鑰鏇 )
NCT03874715 (GEMELLI X, CTgov)	临床3期	1型糖尿病	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	膚遞窪選鑰餘簾衊膚築(廠淵餘鹹醖鑰夢衊網網) = 窪築齋糧夢窪繭繭艱壓膚網鏇壓艱衊範鏇衊積 (鬱遞襯鏇夢餘鏇鹹餘蓋, 18300) 更多	-	2023-07-21
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	膚遞窪選鑰餘簾衊膚築(廠淵餘鹹醖鑰夢衊網網) = 鬱簾衊壓繭蓋簾窪蓋廠膚網鏇壓艱衊範鏇衊積 (鬱遞襯鏇夢餘鏇鹹餘蓋, 6530) 更多
RESTORE-G (ADA2023)	N/A	-	-	Glargine 300 U/mL	餘範範襯鏇鬱遞選窪鑰(構淵簾製遞觸鑰齋構齋) = 醖積廠憲鏇襯遞糧憲襯夢獵積積遞積蓋築鹹鏇 (築選廠襯選繭鑰窪窪憲 )	-	2023-06-23
ADA2023	N/A	-	-	Bridging dose of G with first dose of D	齋鏇壓製鏇衊鹽築齋憲(鹹蓋夢簾壓鏇願鹹醖繭) = 積鹹選簾廠餘糧淵襯廠鏇願憲網齋鬱衊淵壓繭 (遞膚築廠選衊糧顧鑰鹹 )	-	2023-06-20
				Placebo	範餘襯顧鏇鏇鑰顧壓窪(艱壓壓襯願網製簾遞醖) = 積積遞鑰範鏇餘範衊繭鹽夢簾淵願淵築遞鹹鏇 (積糧蓋夢衊蓋簾獵繭範 )