The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.

开始日期2023-08-30

申办/合作机构-

CTRI/2019/05/019416 / Recruiting临床3期

A 26-week, Randomized, Open-label, Parallel-groupComparison of SAR341402 Mix 70/30 to NovoMixÂ®30 inAdult Patients with Diabetes Mellitus using Pre-mixInsulin Analogs - GEMELLI M

开始日期2019-09-05

申办/合作机构

Sanofi-Synthelabo (India) Pvt Ltd.

NCT03874715 / Completed临床3期

Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Primary Objective:
To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
To compare the effects of alternating administration of SAR341402 and NovoLog with continuous use of NovoLog on immunogenicity.
To evaluate the safety of alternating administration of SAR341402 and NovoLog versus continuous use of NovoLog.
To compare other PK parameters between the two treatment arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog).

开始日期2019-03-11

申办/合作机构

Sanofi

100 项与门冬胰岛素生物类似药(Sanofi) 相关的临床结果

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项与门冬胰岛素生物类似药(Sanofi) 相关的文献（医药）

2024-02-01·Diabetes, obesity & metabolism

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial

Article

作者: Barnes, Cathy ; Nakhle, Samer ; Shah, Viral N ; Bailey, Timothy S ; Wernicke-Panten, Karin ; Al-Karadsheh, Amer ; Pierre, Suzanne ; Teichert, Lenore ; Mandry, Jose ; Rotthaeuser, Baerbel ; Mukherjee, Bhaswati ; Kramer, Daniel ; Schmider, Wolfgang

Abstract:

Aim:

To assess whether multiple switches between SAR341402 biosimilar insulin aspart (SAR‐Asp) and the insulin aspart reference product (NovoLog; NN‐Asp) leads to equivalent pharmacokinetic (PK) exposure compared with continuous use of NN‐Asp in adults with type 1 diabetes (T1D).

Materials and Methods:

This multicentre, open‐label, phase 3 study randomized (1:1) 210 subjects with T1D treated with once‐daily insulin glargine U100 as basal insulin to four 4‐week periods of alternating multiple daily injections of SAR‐Asp and NN‐Asp (NN‐Asp for the first 4 weeks, SAR‐Asp in the last 4 weeks; switching group) versus 16 weeks of continuous NN‐Asp (non‐switching group). At week 16, a single dose (0.15 U/kg) of SAR‐Asp in the switching group (n = 95) or NN‐Asp in the non‐switching group (n = 105) was given in the morning before breakfast. Primary PK endpoints were area under the plasma concentration curve (AUC) and maximum plasma concentration (Cmax) of SAR‐Asp versus NN‐Asp after the single dose at week 16.

Results:

The extent of PK exposure was similar between the two treatments (SAR‐Asp in the switching group and NN‐Asp in the non‐switching group) at week 16, with point estimates of treatment ratios close to 1. The 90% confidence intervals for AUC treatment ratios were contained within 0.8‐1.25. For Cmax in the primary analysis set, the upper confidence limit was 1.32. This was because of the profiles of three participants with implausible high values. A prespecified sensitivity analysis excluding implausible values showed results contained within 0.8‐1.25.

Conclusions:

PK exposure of SAR‐Asp (switching group) and reference NN‐Asp (non‐switching group) were similar, supporting interchangeability between these two insulin aspart products.

2024-01-01·Diabetes, obesity & metabolism

Associations of bolus insulin injection frequency and smart pen engagement with glycaemic control in people living with type 1 diabetes

Article

作者: Møller, Jonas Bech ; Hartvig, Niels Vaever ; Jendle, Johan ; Sørensen, Mads Reinholdt ; Kaas, Anne ; Hellman, Jarl

Abstract:

Aim:

To evaluate whether both bolus insulin injection frequency and smart pen engagement were associated with changes in glycaemic control, using real‐world data from adults with type 1 diabetes (T1D).

Materials and Methods:

Adults using a smart pen (NovoPen 6) to administer bolus insulin (fast‐acting insulin aspart or insulin aspart) alongside continuous glucose monitoring were eligible for inclusion. Smart pen engagement was characterized by number of days with pen data uploads over the previous 14 days. Glycaemic control was evaluated by analysing glucose metrics.

Results:

Overall, data from 1194 individuals were analysed. The number of daily bolus injections was significantly associated with time in range (TIR; 3.9‐10.0 mmol/L [70‐180 mg/dL]; P < 0.0001). Individuals administering, on average, three daily bolus insulin injections had an estimated 11% chance of achieving >70% TIR. The probability of achieving >70% TIR increased with the mean number of daily bolus injections. However, the percentage of TIR was lower on days when individuals administered higher‐than‐average numbers of injections. The observed mean number of daily bolus injections administered across the study population was lower than the optimal number required to reach glycaemic targets (4.8 injections vs. 6‐8 injections). Smart pen engagement was significantly associated with improved TIR.

Conclusions:

Glycaemic control was associated with daily bolus insulin injection frequency and smart pen engagement. A treatment regimen combining an optimal bolus injection strategy, and effective smart pen engagement, may improve glycaemic control among adults with T1D.

2023-10-21·Indian journal of pediatrics

Effect of Postmeal Fast-Acting Insulin Aspart Injection on the Frequency of Hypoglycemia among Pre-School Children with Type 1 Diabetes: An Open-Label, Cross-Over, Randomized Control Trial.

Article

作者: Kumar, Rakesh ; Dayal, Devi ; Pattanaik, Smita ; Yadav, Jaivinder ; Patil, Amol ; Yadav, Arti

OBJECTIVES:

To study the effect of postmeal Fast-acting insulin Aspart (Fiasp^®) on the frequency of hypoglycemia compared to premeal injection among preschool children with type 1 diabetes.

METHODS:

A single-center trial was conducted among 65 pre-school children (6 mo to 6 y) with Type 1 diabetes for at least 6 mo, on multiple daily insulin injections. Children were randomized to receive their meal bolus postmeal or premeal for the first 3 mo, followed by cross-over at 3 mo. The two groups were compared at the end of 6 mo for the change in frequency of hypoglycemia and hyperglycemia, HbA1c, glycemic variability, and parental satisfaction. Ten children (5 in each group) underwent pharmacokinetic studies. The trial was approved by Institutional Ethics Committee and registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

RESULTS:

Fifty-four children completed the study, with 27 children in each group. There were no significant differences in the frequency of clinical (p = 0.921), severe (p = 0.167) or serious (p = 0.753) hypoglycemia in the two groups. There were no differences in secondary outcome parameters and pharmacokinetics.

CONCLUSIONS:

The premeal or postmeal injection of Fiasp^® does not affect the frequency of hypoglycemia or other glycemic control parameters among pre-school children with Type 1 diabetes.

TRIAL REGISTRATION:

The trial is registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

项与门冬胰岛素生物类似药(Sanofi) 相关的新闻（医药）

2022-11-22

·生物制品圈

降糖赛道：分子互作技术助您笑傲江湖

这两年集采“灵魂砍价”的新闻频频出现，特别是在胰岛素领域尤为突出。据估算，2021年全国胰岛素集采量2.1亿支，涉及金额170亿，中选产品价格平均降幅 48%。胰岛素集采对于药企而言，喜忧参半。喜的是，集采后中外企业的市场格局会发生变化，有利于推进中选企业降低生产成本和新药研发，推动产业优化升级。忧的是，短期内股价下降，营收数字下滑，集采阵痛明显。此刻，对于药企而言，研发出质优价廉的产品成为当务之急。今天，我们就通过赛诺菲研发Insulin aspart Sanofi剑指诺和诺德NovoRapid的案例，看分子互作“金标准”的Biacore如何助你在降糖赛道笑傲江湖。胰岛素领域的头把交椅一直被诺和诺德占据，NovoRapid更是业界明星产品。2020年，欧盟委员会批准Insulin aspart Sanofi上市，这对NovoRapid产生巨大挑战。SAR341402（Insulin aspart Sanofi）是由赛诺菲公司研发，以NovoRapid为原型药，经EMA批准上市的胰岛素类似药。SAR341402是利用重组DNA技术由非致病性大肠杆菌产生的速效胰岛素，其与人胰岛素同源，唯一的不同点在于将人胰岛素氨基酸链 B28 位的脯氨酸替换为天门冬氨酸。正是由于此修饰使得门冬胰岛素通过电荷排斥效应阻止胰岛素自我聚合，从而达到起效快、活性高的特点。在SAR341402申报报告中，与受体的结合活性测定是药效学研究的重点。面对众多分子互作的检测技术，研究人员最终选择了Biacore SPR技术，理由很简单：快速、实时、直接的检测方法受到研究人员的认可（在讲究内容精简的药物申报报告中，点出Biacore SPR技术具备的三大优势，着实可见研究人员对于Biacore的喜爱）。在检测实验中，研究人员首先将胰岛素受体IR-A 或 IR-B偶联在Biacore传感芯片上。随后，将SAR341402 （四个批次）、参考药物（NovoLog、NovoRapi 各三批）在特定浓度范围内进行检测，每批次药物重复6次实验。四个检测数据（ka1, kd1, ka2, kd2）分别拟合计算，同时计算每个药物对应的加权几何平均值，并且获得对应95%置信区间（见下表）。获得上述数据后，再对三个药物进行两两对比，获取比值及对应90%置信区间（见下表）。针对于结合和解离速率常数 ka1、ka2、kd1、kd2，平均结合和解离速率常数比值的90%置信区间落在 0.70 - 1.43 接受度范围内，表明了SAR341402与参考药物在胰岛素受体IR-A 、 IR-B的结合动力学数据上是相似的。随后，研究人员再将IGF-1受体偶联在Biacore传感芯片上，按照与胰岛素受体相似的检测方法进行检测，拟合计算获得四个检测数据（ka1, kd1, ka2, kd2），同时计算每个药物对应的加权几何平均值，并且获得对应95%置信区间（见下表）。获得上述数据后，再对三个药物进行两两对比，获取比值及对应90%置信区间（见下表）。针对于结合和解离速率常数 ka1、ka2、kd1 和 kd2，平均结合和解离速率常数比值的90%置信区间落在 0.70 - 1.43 接受度范围内，表明了SAR341402与参考药物在IGF-1受体的结合动力学数据上也是相似的。对于上述实验数据，可能有些小伙伴会疑问：这些数据到底表现出Biacore哪些惊艳的特点？作者认为可以用一句话概括：高数据质量下的高通量检测与大数据分析能力。首先，两位点结合模型，三药物直接对比，十批次药物检测，一百八十组数据分析，这都表现出Biacore具备多样的结合模型分析模块，高通量检测速度，大数据分析处理能力。此外，如此亮眼的CV数据更是让人惊艳于Biacore的整体数据质量。这么大样本，低CV值的数据结果，就要求仪器检测精度与稳定性必须非常高。作为行业的金标准，Biacore检测精度与检测稳定性是市面其他设备无法相提并论的，其次，千分之一度的温控精度保障了检测温度敏感型样品的刚性需求，而且，样品板封膜与钢针穿刺取样的设计保证了整个检测过程中样品浓度始终不变，保证无论检测时间长或短，样品顺序前或后，数据重复性超高的效果。也就是因为Biacore如此优异的表现，助力了赛诺菲Insulin aspart Sanofi的上市。向来枉费推移力,此日中流自在行。在如今竞争激烈的降糖赛道，Biacore将通过“金标准”的品质，助力药企研发更优的产品，让患者少花钱用好药，让企业面对竞争，从容应对，笑傲江湖。Biacore一直致力于用创新技术，拓展研究领域，提高研发效率，加速生物疗法，基于用户需求不断改进非标记生物分子相互作用分析系统，更好地为基础科研、药物研发开创未来。肩负这一使命，我们终于迎来了新一代SPR系统——Biacore™ 1 系列，在此诚邀每一位关注Biacore的您加入我们，在云端共同见证Biacore™ 1 系列的诞生，与行业大咖一同探索分子互作前沿进展，揭幕下一代分子相互作用研究的新浪潮！2022.11.24敬请期待，不见不散！参考文献：Assessment report EMA/CHMP/269410/2020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点，不代表本站立场。

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100 项与门冬胰岛素生物类似药(Sanofi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10AD05 A10AB05	DB01306

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	日本	Sanofi KK	2021-03-23
糖尿病	欧盟	Sanofi Winthrop Industrie SA	2020-06-25
糖尿病	冰岛	Sanofi Winthrop Industrie SA	2020-06-25
糖尿病	列支敦士登	Sanofi Winthrop Industrie SA	2020-06-25
糖尿病	挪威	Sanofi Winthrop Industrie SA	2020-06-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床3期	美国	Sanofi	2019-03-11

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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


NCT03874715 (CTgov)	临床3期	1型糖尿病	210	Insulin Aspart+Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	願鏇鑰遞遞築鹽蓋糧窪(糧膚齋積範製憲齋觸憲) = 簾衊醖築鹽淵鹹廠襯壓艱鬱積鹽顧顧願選廠簾 (願膚憲醖膚膚窪齋簾襯, 鹽餘觸衊淵鑰獵夢繭築 ~ 鹹淵獵衊蓋構構鏇膚夢) 更多	-	2023-07-21
				Insulin Aspart+Insulin glargine U100 (Non-switching: NovoLog)	願鏇鑰遞遞築鹽蓋糧窪(糧膚齋積範製憲齋觸憲) = 範憲範夢憲艱網憲選繭艱鬱積鹽顧顧願選廠簾 (願膚憲醖膚膚窪齋簾襯, 窪選壓觸遞壓獵簾網繭 ~ 壓範簾廠齋網遞構膚範) 更多
NCT03211858 (GEMELLI 1, Pubmed) 人工标引	临床3期	糖尿病	597	Insulin Glargine+SAR341402	鬱積繭遞壓簾鹽遞鏇繭(遞鬱齋製壓鏇鬱壓糧餘) = 範鬱窪獵簾衊鬱遞醖蓋鏇鹽觸淵繭夢餘遞願簾 (膚夢鑰鏇網鏇廠糧襯製 )	相似	2020-02-01
				Insulin Glargine+Originator Insulin Aspart	鬱積繭遞壓簾鹽遞鏇繭(遞鬱齋製壓鏇鬱壓糧餘) = 艱淵憲壓觸積簾艱顧範鏇鹽觸淵繭夢餘遞願簾 (膚夢鑰鏇網鏇廠糧襯製 )