A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

Primary Objective:
To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose
Secondary Objectives:
* To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
* To assess the safety and tolerability of the test and the reference formulation of insulin lispro

开始日期2019-03-26

申办/合作机构

Sanofi

NCT02603510

/ Completed临床1期

A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

Primary Objective:
* Assess the safety of SAR342434 and Humalog when used in external pumps.
Secondary Objectives:
* Intervals for infusion set changes.
* Incidence of insulin pump alarms for infusion set occlusion.
* Patient observation of infusion set occlusion.
* Adverse events including bruising at the infusion site and injection site reactions.

开始日期2015-11-01

申办/合作机构

Sanofi

NCT02294474

/ Completed临床3期

Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

Primary Objective:
To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) also using insulin glargine.
Secondary Objectives:
To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; To assess the relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c <7.0% and <=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose.
To assess safety of SAR342434 and Humalog.

开始日期2015-01-01

申办/合作机构

Sanofi

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项与赖脯胰岛素生物类似药(Sanofi) 相关的文献（医药）

2025-07-01·DIABETES OBESITY & METABOLISM

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups—Sharing Canadian perspectives

Review

作者: Chu, L. ; Abitbol, A.

Abstract:

Background:

The rising cost of insulins are significantly impacting health care expenditure, thereby limiting access to treatment for more people affected by diabetes. Fear and misunderstanding of insulin therapy have worsened with the emergence of biosimilar insulins. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference.

Results:

There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty ™. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins.

Conclusion:

Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. Tailoring effective conversations to patient needs ensures the best possible therapeutic outcomes.

Plain Language Summary:

This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost‐effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials, comparative studies evaluating efficacy and safety and manufacturing quality control. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Health care providers are encouraged to stay up to date on the latest guidelines and recommendations regarding biosimilar insulin interchangeability to ensure safe and cost‐effective use of these products. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins. A summary of adults with diabetes from this registry showed 3.8% of individuals with T1D were prescribed Basaglar® before April 2023 compared to 12.0% after January 2024. For the T2D cohort, the use of basal biosimilar insulins, Basaglar® and Semglee®, similarly increased by approximately 10% and 2% after January 2024, respectively. The use of bolus biosimilar insulins also increased after January 2024 by approximately 28% in the T1D cohort and 60% in the T2D cohort using insulin therapy. Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. People living with diabetes must have access to safe and effective treatment options, and they should be able to obtain appropriate medications at an affordable price and in a fair and timely manner.

2022-06-01·Clinical pharmacology in drug development

Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan‐Approved Humalog Insulin Lispro in Healthy Japanese Subjects

Article

作者: Schmider, Wolfgang ; Nowotny, Irene ; Yoshihara, Tatsuya ; Takahashi, Yoshinori ; Kajiwara, Miyuki ; Shiramoto, Masanari ; Muto, Hideya

Abstract:

This phase 1 study compared the pharmacokinetic (PK) and glucose pharmacodynamic (PD) characteristics of biosimilar SAR342434 insulin lispro and Japan‐reference Humalog insulin lispro. This was a randomized, double‐blind, 2‐period, crossover study. Thirty‐six healthy Japanese male subjects underwent a 10‐hour euglycemic clamp following a single subcutaneous 0.3‐U/kg dose of SAR342434 or Humalog. Insulin lispro concentration and blood glucose were measured, and the glucose infusion rate (GIR) was adjusted to maintain the target blood glucose level. Primary PK end points were maximum plasma insulin lispro concentration and area under the plasma insulin concentration–time curve (AUC) from time 0 to the last quantifiable concentration. Primary PD end points were area under the GIR–time curve from time 0 to 10 hours and maximum GIR. PK exposure (maximum plasma concentration and AUC from time 0 to the last quantifiable concentration) and PD activity (GIR‐AUC from time 0 to 10 hours and maximum GIR) were similar between treatments. Geometric mean ratios were close to 1, and the corresponding 90% and 95%CIs (PK and PD activity, respectively) were within the 0.80 to 1.25 equivalence range. SAR342434 and Humalog were well tolerated. In healthy Japanese males, SAR342434 and Humalog showed similar PK exposure profiles and PD potency, in support of SAR342434 use as a biosimilar product.

2020-08-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy3区 · 医学

Update on Biosimilar Insulins: A US Perspective

3区 · 医学

Review

作者: Puri, Ritika ; McGill, Janet B ; Zhang, Rong M

The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar^® (insulin glargine) and Admelog^® (insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option to apply for interchangeability of the biosimilar insulin with the reference product. This abbreviated clinical testing may open the doors for numerous follow-on insulin products, with unknown supply-chain and fiscal ramifications. This review will highlight the development process of biosimilar insulin in the US and the recent regulatory changes that can aid this process. We will also discuss challenges for prescribers and patients who are navigating this ever-changing landscape. These new regulations for biosimilar insulins will have ramifications for patients, healthcare providers, and third-party payers, though the direction and scope of these changes is unclear.

项与赖脯胰岛素生物类似药(Sanofi) 相关的新闻（医药）

2025-04-25

·GBIHealth

赛诺菲2025Q1财报：全球增长9.7%，中国市场下滑1.7%

药械追踪No.1 / 康方生物PD-1单抗安尼可在美获批，治疗鼻咽癌2025年4月25日，康方生物（9926.HK）宣布，派安普利单抗（商品名：安尼可）已获得美国食品药品监督管理局（FDA）批准上市，用于治疗复发或转移性鼻咽癌的一线治疗，以及以铂类为基础的至少一线化疗治疗失败后的治疗两项适应证。派安普利单抗是一款新型差异化PD-1单抗，由康方生物自主研发、并由康方生物与中国生物旗下正大天晴药业集团合资的天晴康方负责后续开发和商业化。其用于晚期鼻咽癌一线和二线后线治疗此前已在中国获得批准。Ⅲ期AK105-304研究和AK105-202研究的积极结果支持了FDA此次批准，此前FDA曾授予派安普利单抗治疗鼻咽癌的1项突破性疗法认定（BTD）、1项孤儿药资格认定（ODD）和1项快速通道资格（FTD）。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 赛诺菲退还Innate CD123靶向ANKET药物相关权益2025年4月25日，Innate Pharma SA（（以下简称“Innate”）宣布，已与赛诺菲协商，对双方于2016年1月签署的研究合作与许可协议（以下简称“2016年协议”）进行重要调整，同时2022年研究合作与许可协议（以下简称“2022年协议”）保持不变。2016年协议允许赛诺菲利用Innate专有的多特异性抗体平台ANKET研发SAR’579/IPH6101，这是一款CD123 ANKET药物。本次协议调整后，赛诺菲将SAR’579/IPH6101的完整权益退还Innate。2024年4月，赛诺菲将SAR’579/IPH6101推进至II期临床阶段，双方后续将就正在进行的研究制定过渡计划。基于2016年协议，赛诺菲自Innate获得的另一项目SAR’514/ IPH6401（BCMA ANKET）将继续推进。赛诺菲计划提前终止SAR’514/ IPH6401用于复发或难治性多发性骨髓瘤患者的I/II期临床试验（临床试验登记号：NCT05839626），并将重新聚焦其用于自身免疫适应证的开发。此外，根据双方协商结果，赛诺菲可能通过增发新股的方式对Innate进行潜在投资，投资金额最高可达1500万欧元；股权投资的具体规模和价格将根据当前市场条件确定。ANKET是Innate的专有平台，用于开发下一代多特异性NK细胞衔接器。目前除了SAR’514/ IPH6401，赛诺菲和Innate还在合作开发B7-H3靶向的ANKET项目IPH62。根据2022年协议，赛诺菲仍保留选择一个新的ANKET靶点的权利。->点击文末阅读原文，解锁完整双语新闻No.2 / 甘李药业2024财报：增收16.77%至30.45亿元2025年4月25日，甘李药业（603087.SH）发布2024年财务业绩。公司全年实现营业收入30.45亿元，同比增长16.77%；归母净利润为6.15亿元，同比增长80.75%。期内研发投入6.46亿元，占营收比重21.20%报告期内，甘李药业国内外营业收入稳健增长。在中国市场，作为国产胰岛素领军企业，甘李药业在首轮集采中实现销量持续增长，接续集采申报的六款胰岛素产品全数中选，且所有参加组别均有A类中选产品，获得更高协议量的同时价格也适当回调。全年国内销售收入达25.18亿元，同比增长15.38%。在国际市场，公司通过了欧盟EMA上市批准前GMP检查，这也是国产胰岛素类似物注射液首次通过EMA的GMP检查，标志着公司已具备甘精胰岛素注射液、赖脯胰岛素注射液、门冬胰岛素注射液及预填充注射笔的欧盟商业化生产条件。报告期内，公司出口额持续攀升，国际收入达5.28亿元，同比增长23.89%。甘李药业在研管线中，博凡格鲁肽（GZR18）注射液已顺利完成中国II期临床研究并达到主要终点，在2型糖尿病患者及肥胖/超重受试者中均取得良好数据。另一款核心产品GZR4注射液（胰岛素周制剂）在中国2型糖尿病患者中开展的II期临床试验也达到了主要终点，在降低HbA1c方面优于德谷胰岛素（诺和达）；目前GZR4已启动3项中国III期临床研究，分别为SUPER-1（胰岛素初治）、SUPER-2（基础胰岛素经治）及SUPER-3（基础胰岛素联合餐时胰岛素强化治疗）。->点击文末阅读原文，解锁完整双语新闻No.3 / 德国默克拟以35亿美元收购SpringWorks近日，《华尔街日报》报道称，德国默克拟以35亿美元收购美国生物制药公司SpringWorks Therapeutics（简称“SpringWorks”）。SpringWorks股价周四下午上涨9.03%，至44.93美元。据知情人士透露，两家公司已就接近每股47美元的定价达成一致。如果谈判顺利，协议最早可能在下周一完成。SpringWorks于2023年底推出了第一款药物Ogsiveo（nirogacestat），这是一种口服γ分泌酶抑制剂，也是FDA批准的首个成人硬纤维瘤治疗药物。2024年，SpringWorks营收1.91亿美元，其中Ogsiveo贡献1.72亿美元。2025年初，SpringWorks第二款新药Gomekli（mirdametinib）获得FDA批准，这是一种口服小分子MEK抑制剂，用于治疗无法完全切除的患有1型神经纤维瘤病（NF1）且伴有症状性丛状神经纤维瘤（PN）的成人和儿童患者。->点击文末阅读原文，解锁完整双语新闻No.4 / 赛默飞世尔未来四年将在美追加20亿美元投资2025年4月25日，赛默飞世尔（Thermo Fisher Scientific Inc.，NYSE: TMO）宣布，未来四年将在美国追加20亿美元投资，以强化美国在生命科学领域的创新、制造与经济竞争力。投资计划具体包括：投入15亿美元资本支出，用于提升和扩大美国本土的制造业务；配套投入5亿美元研发资金，聚焦高影响力创新领域。目前，赛默飞世尔在美国37个州拥有64家制造工厂，提供生产分析仪器、专科诊断产品以及生命科学解决方案，并为制药创新企业提供合同研发与制造服务。未来四年，赛默飞世尔将继续扩大其在美国的影响力。->点击文末阅读原文，解锁完整双语新闻No.5 / 赛诺菲2025Q1财报：全球增长9.7%，中国市场下滑1.7%赛诺菲（纳斯达克代码：SNY）近日公布2025年第一季度财报（2025Q1）。公司全球净销售额达98.95亿欧元（约112.5亿美元，GBI计算），同比增长9.7%（按固定汇率计算，下同）。在成熟药物表现方面，过敏与哮喘重磅炸弹药物达必妥（度普利尤单抗）持续强劲增长，销售额同比增长20.3%至34.8亿欧元（39.6亿美元）。长效胰岛素来得时（甘精胰岛素）同比增长24.4%，达4.5亿欧元（5.12亿美元）。8款新上市药物合计贡献8.47亿欧元销售额，同比增长43.8%，其中：血友病疗法Altuviiio（重组凝血因子VIII）销售额达2.51亿欧元（2.85亿美元），同比增长100%，CEO保罗·哈德森称其有望成为公司下一款重磅炸弹药物。疫苗业务方面，销售额同比增长11.4%至13.3亿欧元（15.1亿美元）。其中，呼吸道合胞病毒（RSV）疫苗乐唯初（尼塞韦单抗）销售额2.84亿欧元（3.23亿美元），同比激增54.9%。从地区来看，美国市场为主要增长驱动力，收入同比增长15.4%至46.6亿欧元（53亿美元）；欧洲市场收入微增0.5%至20.4亿欧元（23亿美元）；世界其他地区收入达32亿欧元（36亿美元），同比增长8.4%；但中国市场（计入世界其他地区）收入同比下滑1.7%至7.01亿欧元（7.97亿美元）。公司财报电话会内容亮点之一是首席财务官Francois Rodger巧妙回避了针对美国加征关税潜在影响的提问，他表示：“目前公司对于美国加征关税的问题尚无具体信息可分享，但公司已考虑了所有可能的情景，必要时将适时通报进展”。赛诺菲2025年的业绩指引保持不变，预计全年收入将实现中高个位数百分比增长。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ xujingou@baidu.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报孤儿药突破性疗法临床3期临床1期

2023-03-03

·BioSpace

Sanders Calls on Sanofi, Novo to Follow Lilly in Cutting Insulin Prices

Courtesy of Gage Skidmore, Creative Commons Wednesday, Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices. The letter follows Eli Lilly’s announcement, made the day it reduced its widely used insulin products by 70%. The Indianapolis pharma is also expanding its Insulin Value Program to cap patients’ out-of-pocket costs at $35 per month. The 70% price cut will include Humalog (insulin lispro injection), Lilly’s most commonly prescribed insulin, and Humulin (insulin human). These will be effective in the fourth quarter of 2023. On May 1, the cost of Lilly’s non-branded product Insulin Lispro Injection will drop to $25 per vial, making it the “lowest list-priced mealtime insulin available,” according to the company’s announcement. “We know that 7 out of 10 Americans don't use Lilly insulin,” David Ricks, CEO, Lilly, said in a statement. Ricks urged “policymakers, employers and others” to also take steps to make insulin more affordable. "Sanofi believes that no one should struggle to pay for their insulin, regardless of their insurance status or income level, which is why we have a suite of innovative and patient-centric savings programs to help people reduce their prescription medicine costs," said Olivier Bogillot, head of U.S. General Medicines, Sanofi in a statement. In an email to BioSpace, Bogillot said the company’s copay assistance programs are available to all commercially insured consumers, regardless of income level and insurance plan. For most participating patients, Sanofi’s copay program limits out-of-pocket expenses for diabetes medicines to $15. In identical letters sent to Paul Hudson and Lars Fruergaard Jørgensen, CEOs of Sanofi and Novo, respectively, the independent policymaker called on both companies to substantially lower their insulin prices. Together with Lilly, Sanofi and Novo control around 90% of the insulin market in the U.S. In the letters, Sanders detailed how insulin prices in the U.S. have increased by more than 1,000% since 1996 due to what he called “unacceptable corporate greed.” In 2019, the drug cost an average of $58 per 30-day fill, according to a U.S. Department of HHS report. For 24% of consumers, insulin fills cost more than $70. Insulin was discovered by Canadian scientists in 1921, who sold the patent for $1. “People with diabetes should not be forced to pay $98 for a vial of insulin that costs just $8 to manufacture and can be purchased in Canada for just $12,” Sanders said. Sanders also plans to introduce legislation to put a $20 cap on insulin prices per vial.

2023-03-03

·BioSpace

Sanders Calls on Sanofi, Novo to Follow Lilly in Cutting Insulin Prices

Sen. Bernie Sanders/Courtesy of Gage Skidmore, Cre Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices. Sen. Bernie Sanders/Courtesy of Gage Skidmore, Creative Commons Wednesday, Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices. The letter follows Eli Lilly’s March 1 announcement that it would reduce the cost of its widely used insulin products by 70%. The Indianapolis pharma is also expanding its Insulin Value Program to cap patients’ out-of-pocket costs at $35 per month. The 70% price cut will include Humalog (insulin lispro injection), Lilly’s most commonly prescribed insulin, and Humulin (insulin human). These will be effective in the fourth quarter of 2023. On May 1, the cost of Lilly’s non-branded product Insulin Lispro Injection will drop to $25 per vial, making it the “lowest list-priced mealtime insulin available,” according to the company’s announcement. “We know that 7 out of 10 Americans don’t use Lilly insulin,” David Ricks, CEO, Lilly, said in a statement. Ricks urged “policymakers, employers and others” to also take steps to make insulin more affordable. “Sanofi believes that no one should struggle to pay for their insulin, regardless of their insurance status or income level, which is why we have a suite of innovative and patient-centric savings programs to help people reduce their prescription medicine costs,” said Olivier Bogillot, head of U.S. General Medicines, Sanofi in a statement. In an email to BioSpace , Bogillot said the company’s copay assistance programs are available to all commercially insured consumers, regardless of income level and insurance plan. For most participating patients, Sanofi’s copay program limits out-of-pocket expenses for diabetes medicines to $15. For its part, Novo is also running several programs to make insulin more accessible to patients, Natalia Salomao, senior director, Corporate Reputation & Brand, told BioSpace in an email. The company has an offering through Walmart that provides insulin at around $25 per vial, she said. In identical letters sent to Paul Hudson and Lars Fruergaard Jørgensen, CEOs of Sanofi and Novo, respectively, the independent policymaker called on both companies to substantially lower their insulin prices. Together with Lilly, Sanofi and Novo control around 90% of the insulin market in the U.S. In the letters, Sanders detailed how insulin prices in the U.S. have increased by more than 1,000% since 1996 due to what he called “unacceptable corporate greed.” In 2019, the drug cost an average of $58 per 30-day fill, according to a U.S. Department of HHS report. For 24% of consumers, insulin fills cost more than $70. Insulin was discovered by Canadian scientists in 1921, who sold the patent for $1. “People with diabetes should not be forced to pay $98 for a vial of insulin that costs just $8 to manufacture and can be purchased in Canada for just $12,” Sanders said. Sanders also plans to introduce legislation to put a $20 cap on insulin prices per vial.

100 项与赖脯胰岛素生物类似药(Sanofi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04477	-	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
1型糖尿病	美国	Sanofi-Aventis U.S. LLC	2017-12-11
2型糖尿病	美国	Sanofi-Aventis U.S. LLC	2017-12-11
糖尿病	欧盟	Sanofi Winthrop Industrie SA	2017-07-19
糖尿病	冰岛	Sanofi Winthrop Industrie SA	2017-07-19
糖尿病	列支敦士登	Sanofi Winthrop Industrie SA	2017-07-19
糖尿病	挪威	Sanofi Winthrop Industrie SA	2017-07-19

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
妊娠期糖尿病	临床2期	美国	Sanofi	2013-04-01

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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


NCT02603510 (Pubmed)	临床1期	1型糖尿病	27	SAR-Lis	願衊膚廠夢繭壓願糧簾(餘鹽鹹願製醖蓋衊簾簾) = 齋繭願積鏇鏇淵淵鹹蓋構鏇艱襯製獵壓構構範 (糧選廠鑰膚壓憲餘積淵 ) 更多	-	2018-05-01
				Ly-Lis	願衊膚廠夢繭壓願糧簾(餘鹽鹹願製醖蓋衊簾簾) = 鬱鹹繭蓋膚範築醖蓋遞構鏇艱襯製獵壓構構範 (糧選廠鑰膚壓憲餘積淵 ) 更多
NCT02273180 (SORELLA1 \| SORELLA-1 \| SORELLA 1, CTgov)	临床3期	1型糖尿病	507	Insulin glargine HOE901+SAR342434 (SAR342434)	範鏇鑰糧積簾齋構遞製(構鬱鹹鏇構窪積鹹餘獵) = 艱選鹹簾襯壓糧網觸夢遞遞網衊膚製築鏇構鬱 (鏇蓋築窪願壓範鹽範餘, 0.051) 更多	-	2018-01-18
				Insulin glargine HOE901+Humalog (Humalog)	範鏇鑰糧積簾齋構遞製(構鬱鹹鏇構窪積鹹餘獵) = 範遞蓋壓獵選願齋膚網遞遞網衊膚製築鏇構鬱 (鏇蓋築窪願壓範鹽範餘, 0.05) 更多
NCT02294474 (SORELLA 2 \| SORELLA2, CTgov)	临床3期	2型糖尿病	505	insulin glargine HOE901+SAR342434 (SAR342434)	繭艱鬱餘選積積繭鹹餘(鬱壓鏇膚繭膚製製觸糧) = 糧遞鹹製醖簾構窪餘膚淵鹹積網積夢積鹽築觸 (鑰憲構構壓獵糧淵鹹製, 0.051) 更多	-	2018-01-18
				insulin glargine HOE901+Humalog (Humalog)	繭艱鬱餘選積積繭鹹餘(鬱壓鏇膚繭膚製製觸糧) = 壓簾壓繭鏇鏇夢願繭網淵鹹積網積夢積鹽築觸 (鑰憲構構壓獵糧淵鹹製, 0.051) 更多
NCT02294474 (SORELLA 2, Pubmed \| Diabetes Technol Ther)	临床3期	2型糖尿病	505	SAR342434 Insulin Lispro	廠繭製製鹽齋淵襯鹹構(鹹選顧製蓋築構繭繭觸) = 餘壓構鹽蓋憲製餘壓鬱築繭鑰遞積範蓋鏇艱觸 (夢鏇顧廠襯憲艱積網壓 )	积极	2018-01-01
				Insulin Lispro (U100; Humalog®; Ly-Lis)	廠繭製製鹽齋淵襯鹹構(鹹選顧製蓋築構繭繭觸) = 簾鑰鬱齋鑰蓋廠窪繭網築繭鑰遞積範蓋鏇艱觸 (夢鏇顧廠襯憲艱積網壓 )
NCT02273180 (SORELLA-1, Pubmed \| Diabetes Technol Ther) 人工标引	临床3期	1型糖尿病	507	SAR342434	築鹽窪鏇衊憲築獵蓋壓(壓積願蓋淵淵鑰繭鑰範) = 觸鑰齋醖獵鹹夢襯構鏇構選鹽膚夢襯憲艱艱鹽 (製鹹願醖築窪鏇網齋蓋 )	相似	2017-09-01
				insulin lispro-Humalog	築鹽窪鏇衊憲築獵蓋壓(壓積願蓋淵淵鑰繭鑰範) = 鹹餘製鏇襯衊餘憲願糧構選鹽膚夢襯憲艱艱鹽 (製鹹願醖築窪鏇網齋蓋 )
NCT02273180 (SORELLA 1, EASD2016)	临床3期	1型糖尿病	507	SAR342434 insulin lispro	憲構願範鑰鹽積簾鏇鹹(簾廠網蓋蓋顧壓鬱壓蓋) = 蓋齋憲鏇糧窪齋醖鹹製鏇醖簾廠廠範顧鑰憲壓 (蓋積網夢膚鹹選醖鑰築, 0.78)	积极	2016-09-15
				Insulin lispro U100	憲構願範鑰鹽積簾鏇鹹(簾廠網蓋蓋顧壓鬱壓蓋) = 願鏇襯廠艱糧廠憲衊壓鏇醖簾廠廠範顧鑰憲壓 (蓋積網夢膚鹹選醖鑰築, 0.64)
NCT02273258 (EASD2015)	临床1期	1型糖尿病	30	SAR342434 solution	廠顧鏇鑰膚築製製糧繭(簾選鹹壓窪夢網鏇遞夢) = similar for SAR342434 solution, US-approved insulin lispro solution, and EU-approved insulin lispro solution 憲糧構廠簾獵範壓廠膚 (鑰蓋鏇鏇遞淵構簾觸築 ) 更多	积极	2015-09-16
				US-approved insulin lispro solution
NCT00607087 (PUMP, CTgov)	临床4期	1型糖尿病	289	Insulin (Insulin Glulisine)	顧襯獵築廠餘觸選構獵 = 願構鏇壓鹹顧構簾夢糧網齋廠窪艱觸憲積糧願 (壓襯餘夢壓鏇膚艱範窪, 窪積願築繭壓鏇製膚艱 ~ 淵糧淵顧製窪壓淵積憲) 更多	-	2010-07-30
				Insulin Aspart (Insulin Aspart)	顧襯獵築廠餘觸選構獵 = 齋鏇衊艱鹽憲艱蓋蓋願網齋廠窪艱觸憲積糧願 (壓襯餘夢壓鏇膚艱範窪, 構艱構獵鏇遞鑰壓艱齋 ~ 糧鹹襯夢糧觸選鏇淵襯) 更多