甘精胰岛素生物类似药(Wockhardt Bio AG)(Insulin glargine biosimilar(Wockhardt Bio AG)) - 药物靶点：INSR_在研适应症：1型糖尿病，2型糖尿病_专利_临床

概要

基本信息

药物类型

生物类似药、激素

别名

Glaritus、Glaritus DispoPen、GlaritusCart

+ [2]

靶点

INSR

作用机制

INSR激动剂(胰岛素受体激动剂)

治疗领域

免疫系统疾病内分泌与代谢疾病

在研适应症

1型糖尿病2型糖尿病

非在研适应症-

原研机构

Wockhardt Bio AG

在研机构

Wockhardt Bio AG

非在研机构-

最高研发阶段批准上市

首次获批日期

印度 (2013-01-01),

1型糖尿病2型糖尿病

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 4851

当前序列信息引自: *****

Sequence Code 31960

当前序列信息引自: *****

关联

2

项与甘精胰岛素生物类似药(Wockhardt Bio AG) 相关的临床试验

NCT01352663 / Withdrawn临床3期

An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.

This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.

开始日期-

申办/合作机构

Wockhardt Ltd.

CTRI/2015/05/005808 / Not yet recruiting临床4期

A Prospective, Open-Label, Randomized, Active Control, Parallel Group, Comparative, Multi-Center, Phase IV Trial to Evaluate the Immunogenicity of Wockhardtâ??s Insulin analogue Glargine (GlaritusÂ®) with Sanofi-Aventis Insulin analogue Glargine (LantusÂ®) in Subjects with Type 2 Diabetes Mellitus

开始日期2015-06-05

申办/合作机构

Wockhardt Ltd.

100 项与甘精胰岛素生物类似药(Wockhardt Bio AG) 相关的临床结果

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100 项与甘精胰岛素生物类似药(Wockhardt Bio AG) 相关的转化医学

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100 项与甘精胰岛素生物类似药(Wockhardt Bio AG) 相关的专利（医药）

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3

项与甘精胰岛素生物类似药(Wockhardt Bio AG) 相关的文献（医药）

2021-01-01·Acta Diabetologica

Correction to: Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus®) and Lantus® in healthy subjects: a double-blind, randomized clamp study

作者: Bhatia, Ashima ; Tawade, Shraddha ; Sahib, Maharaj ; Prasanna Kumar, K M ; Mastim, Mushtaque ; Shah, Manish ; Gobburu, Joga ; Yeshamaina, Sridhar ; Gopalakrishnan, Mathangi ; Kitabi, Eliford Ngaimisi ; Thakur, Dipak

2018-05-01·Acta Diabetologica3区 · 医学

Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus®) and Lantus® in healthy subjects: a double-blind, randomized clamp study

3区 · 医学

Article

作者: Bhatia, Ashima ; Tawade, Shraddha ; Sahib, Maharaj ; Prasanna Kumar, K M ; Mastim, Mushtaque ; Shah, Manish ; Gobburu, Joga ; Yeshamaina, Sridhar ; Gopalakrishnan, Mathangi ; Kitabi, Eliford Ngaimisi ; Thakur, Dipak

AIMSThe objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus^® (test) with the innovator's formulation Lantus^® (reference) using the euglycemic clamp technique in a single-dose, double-blind, randomized, two sequences, four-period replicate crossover study in healthy volunteers (n = 40).METHODSSubjects received subcutaneous administration of the insulin glargine (0.4 IU/kg) formulation at two occasions for test and reference and a 20% glucose solution was infused at variable rate to maintain euglycemia for 24 h.RESULTSBoth PK [area under the plasma concentration time curve (AUC_0-24 h) and maximum insulin concentration (C_max)] and PD endpoints [area under glucose infusion rate time curve (_AUCGIR0-24) and maximum glucose infusion rate (GIR_max)] demonstrated bioequivalence of Glaritus to Lantus with the 90% confidence interval of geometric mean ratio of test to reference entirely contained within 0.80-1.25. Both formulations showed equivalent geometric least-square mean LSM value (0.08 nmol/L) for C_max. The geometric LSM AUC_0-24 h value for Glaritus^® (1.09 h nmol/L) was comparable to Lantus (1.05 h nmol/L). Median T_max values were also identical (12 h for both), and median t1/2 values were also equal (18 h for both). For GIR_Tmax, the difference between the means for the two was not statistically significant. No AEs related to study formulations were reported, and both products were well tolerated.CONCLUSIONSThe test product (Glaritus) was found to be bioequivalent to the reference product (Lantus).CLINICAL TRIAL REGISTRATION NUMBERCTRI/2015/06/005890; http://www.ctri.nic.in/ .

2013-09-01·Journal of Diabetes Science and Technology

Dose Accuracy and Injection Force of Different Insulin Glargine Pens

Article

作者: Adler, Steffen ; Friedrichs, Arnd ; Bohnet, Janine ; Schubert-Zsilavecz, Manfred ; Abdel-Tawab, Mona ; Korger, Volker

Background: Dose accuracy and injection force, representing key parameters of insulin pens, were determined for three pens delivering insulin glargine-based copies, Pen Royale (WR) and DispoPen (WD) for Glaritus® (Wockhardt) and GanLee Pen (GL) for Basalin® (Gan & Lee), compared with pens of the originator, ClikSTAR® (CS) and SoloSTAR® (SS) for Lantus® (Sanofi). Methods: Using the weighing procedure recommended by DIN EN ISO 11608–1:2000, dose accuracy was evaluated based on nonrandomized delivery of low (5 U), mid (30 U), and high (60 U) dosage levels. Injection force was measured by dispensing the maximum dose of insulin (60 U for the GL, WR, and WD; 80 U for the SS and CS) at dose speeds of 6 and 10 U/s. Results: All tested pens delivered comparable average doses within the DIN EN ISO 11608–1:2000 limits at all dosage levels. The GL revealed a higher coefficient of variation (CV) at 5 U, and the WR and WD had higher CVs at all dosage levels compared with the CS and SS. Injection force was higher for the WR, WD, and GL compared with the CS and SS at both dose speeds. In contrast to the CS and SS with an end-of-content feature, doses exceeding the remaining insulin could be dialed with the WR, GL, and WD and, apparently, dispensed with the WD. Conclusions: All pens fulfilled the dose accuracy requirements defined by DIN EN ISO 11608–1:2000 standards at all three dosage levels, with the WR, WD, and GL showing higher dosage variability and injection force compared with the SS and CS. Thus, the devices that deliver insulin glargine copies show different performance characteristics compared with the originator.

100 项与甘精胰岛素生物类似药(Wockhardt Bio AG) 相关的药物交易

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