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更新于：2026-04-03
Insulin Glulisine Recombinant
谷赖胰岛素
更新于：2026-04-03
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2004-04-16), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 4857
来源: *****
Sequence Code 119094
来源: *****
关联
107
项与 谷赖胰岛素 相关的临床试验JPRN-UMIN000041551
Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes - Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes
NCT04019821
Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study
NCT04124302
The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.
100 项与 谷赖胰岛素 相关的临床结果
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100 项与 谷赖胰岛素 相关的转化医学
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100 项与 谷赖胰岛素 相关的专利（医药）
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343
项与 谷赖胰岛素 相关的文献（医药）2026-03-01DIABETES OBESITY & METABOLISM
Immunogenicity, efficacy and safety of a biosimilar insulin glulisine compared with originator in adults with type 1 diabetes mellitus: A phase
III
randomised clinical trial
Article
作者: Makarenko, Igor ; Protsenko, Ekaterina ; Matvienko, Iuliia ; Iliushchenko, Dmitrii ; Parfenova, Tatyana ; Galstyan, Gagik ; Karonova, Tatiana ; Drai, Roman ; Arefeva, Anna
Abstract:
Aims:
To evaluate the immunogenicity, efficacy, and safety of a biosimilar insulin glulisine candidate (T‐Glu) compared to the reference product (R‐Glu) in patients with type 1 diabetes mellitus (T1DM).
Materials and Methods:
In this phase III, randomised, open‐label trial, adult patients with T1DM received either T‐Glu or R‐Glu by prefilled pens as their bolus insulin for 26 weeks. The primary outcome was the proportion of patients with an immune response at Week 26. Secondary endpoints included changes in glycaemia control parameters, insulin dose stability, treatment satisfaction, and other immunogenicity and safety outcomes.
Results:
By Week 26, the immune response persisted in 16% of patients in the T‐Glu group and 24% in the R‐Glu group (
p
> 0.05), confirming similar immunogenicity. HbA1c reduction at Week 26 compared to baseline was similar between groups, with a mean change of 0.53% ± 1.19% in the T‐Glu group and 0.38% ± 1.46% in the R‐Glu group (mean difference: −0.15%, 95% CI: −0.50 to 0.20), demonstrating non‐inferiority (according to a predefined margin of 0.4%). Fasting plasma glucose levels and the seven‐point glucose profile showed no significant differences between groups (
p
> 0.05). Insulin dose remained stable throughout the study, and treatment satisfaction scores improved comparably in both groups (
p
> 0.05). The total number of AEs was similar, and hypoglycaemia was more frequent in the R‐Glu group (
p
< 0.001), with no new safety concerns identified.
Conclusions:
T‐Glu demonstrated similar immunogenicity, efficacy, and safety to R‐Glu in adults with T1DM, supporting its use as a biosimilar insulin glulisine.ClinicalTrials.gov
: NCT07070752.
2025-02-01JOURNAL OF SEPARATION SCIENCE
First Dimension Trap‐and‐Elute Combined with Second Dimension Reversed‐Phase Liquid Chromatography Separation Using a Two‐Dimensional‐Liquid Chromatography‐Tandem Mass Spectrometry System for Sensitive Quantification of Human Insulin and Six Insulin Analogs in Plasma: Improved Chromatographic Resolution and Stability Testing
Article
作者: Stejskal, David ; Jurica, Jan ; Handlos, Petr ; Sistik, Pavel ; Handlosova, Klara ; Andelova, Katerina ; Urinovska, Romana
ABSTRACT:
Multidimensional chromatography coupled to tandem mass spectrometry (MS/MS), including simple sample preparation with protein precipitation, anion conversion with ammonium hydroxide, and solid‐phase extraction using mixed‐mode anion exchange in a 96‐well plate format, has been validated for rapid simultaneous analysis of human insulin and its six analogs (lispro, glulisine, glargine, degludec, detemir, and aspart) in human plasma. This method is critical for clinical diagnostics, forensic investigations, and anti‐doping efforts due to the widespread use of these substances. In the present study, improved chromatographic resolution was achieved using a first‐dimension trap‐and‐elute configuration with an XBridge C18 (2.1 × 20 mm, 3.5 µm) trap column combined with second dimension separation on a Cortecs Ultra‐High‐Performance Liquid Chromatography (UHPLC) C18+ (2.1 × 100 mm, 1.6 µm) analytical column implemented within a two‐dimensional‐LC‐MS/MS system. The total chromatographic run time was 11 min. This setup increases both the resolution and sensitivity of the method. A mobile phase consisting of 0.8% formic acid (FA) in water and 0.7% FA in acetonitrile was used for gradient elution. Bovine insulin was used as the internal standard. MS detection was performed in positive electrospray ionization mode, and the ion suppression due to matrix effects was evaluated. Validation criteria included linearity, precision, accuracy, recovery, lower limit of quantitation, matrix effect, and stability tests with and without protease inhibitor cocktail under different conditions (short‐term stability, long‐term stability, and freeze‐thaw stability). The concentration range for all insulins was 50–15 000 pg/mL, with limits of quantification below the therapeutic reference range for all analytes. Intra‐run precision ranged from 1.1% to 5.7%, inter‐run precision from 0.7% to 5.9%, and overall recovery from 96.9% to 114.3%. The validated method has been implemented successfully by the Department of Forensic Medicine at our hospital for the investigation of unexplained deaths.
2024-08-01PHARMAZIE
Optimization of a mass spectrometric analytical method for the quality assessment of insulin and its analogs.
Article
作者: Andrási, M ; Nebija, D ; Pajaziti, B A ; Pajaziti, B ; Kemlendi, N
The principal aim of this study was to optimize analytical methodology based on mass spectrometry for the evaluation of the quality of recombinant human insulin and its analogs. In this study ESI-MS was used to assess the quality of human insulin, short acting insulin analogs, insulin lispro, insulin aspart and insulin glulisine and long acting analogs including insulin glargine, insulin degludec, and insulin detemir, in respective pharmaceutical formulations. In this study, with the aimed to optimize analytical conditions, different factors influencing the analytical performance such as pH, ionic strength, sample dilution, organic solvent addition were addressed. The study results demonstrated that MS is a suitable technique for the analysis of biotechnological compounds like insulin and its analogs. Although the obtained results provide an important information regarding this methodology, further studies are needed to validate this analytical approach and check for its suitability to be used in the regulatory environment.
100 项与 谷赖胰岛素 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 1型糖尿病 | 澳大利亚 | 2005-05-02 | |
| 2型糖尿病 | 澳大利亚 | 2005-05-02 | |
| 糖尿病 | 美国 | 2004-04-16 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 阿根廷 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 巴西 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 加拿大 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 墨西哥 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 美国 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 阿根廷 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 巴西 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 加拿大 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 墨西哥 | 2008-04-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 262 | T-Glu (Type 1 Diabetes Mellitus) | 壓積餘憲鑰齋廠衊網壓(顧餘顧淵鑰觸範願憲鏇) = 廠憲鑰鬱蓋觸積繭顧壓 鬱製鏇糧鹹獵鏇繭鹽願 (鑰獵襯鬱艱繭築簾願齋 ) 更多 | 积极 | 2025-12-09 | ||
R-Glu (Type 1 Diabetes Mellitus) | 壓積餘憲鑰齋廠衊網壓(顧餘顧淵鑰觸範願憲鏇) = 鑰淵膚範鏇簾憲鏇遞餘 鬱製鏇糧鹹獵鏇繭鹽願 (鑰獵襯鬱艱繭築簾願齋 ) 更多 | ||||||
临床4期 | 16 | (Insulin Glulisine) | 壓衊網願鬱網積艱艱衊(鏇醖淵構遞憲選選襯憲) = 鏇構願齋艱膚鬱鹹觸獵 廠選蓋繭獵餘網壓選夢 (遞壓築築構顧簾鹽鬱選, 15.7) 更多 | - | 2023-09-18 | ||
(Insulin Aspart) | 壓衊網願鬱網積艱艱衊(鏇醖淵構遞憲選選襯憲) = 獵齋齋鏇壓窪網襯願夢 廠選蓋繭獵餘網壓選夢 (遞壓築築構顧簾鹽鬱選, 14.7) 更多 | ||||||
临床2期 | - | Intranasal Glulisine | 繭憲醖鏇鑰醖齋淵觸鹽(觸範齋簾醖糧憲夢觸衊) = No significant difference 壓壓獵鹽衊壓選廠鬱廠 (網製願餘鏇餘艱鏇窪顧 ) 更多 | 不佳 | 2021-05-01 | ||
Placebo | |||||||
临床4期 | 247 | (Basal Bolus Insulin With Glargine U300 and Glulisine Insulin) | 網範壓遞獵獵範膚積窪(顧獵鑰淵餘襯餘築獵醖) = 衊鹽觸鹽獵廠鏇構鹽餘 艱憲衊網構醖顧鏇願繭 (鹽築簾鹽鑰選網鏇鏇廠, 40) 更多 | - | 2020-05-07 | ||
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin) | 網範壓遞獵獵範膚積窪(顧獵鑰淵餘襯餘築獵醖) = 襯築齋壓襯願鬱選夢製 艱憲衊網構醖顧鏇願繭 (鹽築簾鹽鑰選網鏇鏇廠, 46) 更多 | ||||||
临床2期 | 49 | (Insulin Glulisine) | 簾選齋範遞夢艱顧鑰淵(積醖選選繭糧鏇積廠構) = 網襯繭觸窪網醖築繭壓 醖鬱積鹽艱遞鬱廠夢鑰 (積鑰繭觸築範醖衊蓋鏇, 4.2) 更多 | - | 2020-04-09 | ||
Placebo (Placebo) | 簾選齋範遞夢艱顧鑰淵(積醖選選繭糧鏇積廠構) = 獵糧築繭蓋願衊遞齋衊 醖鬱積鹽艱遞鬱廠夢鑰 (積鑰繭觸築範醖衊蓋鏇, 4.8) 更多 | ||||||
临床1期 | 12 | (Insulin (Glulisine), Then Placebo) | 網繭膚製夢積艱選製淵 = 餘顧鬱網壓艱淵壓網淵 餘膚衊繭繭鏇選觸窪繭 (廠網鹹築製觸獵鏇遞鹽, 夢網範鹽膚憲積壓築醖 ~ 遞鏇範膚夢夢膚廠觸鹽) | - | 2019-12-06 | ||
(Placebo, Then Insulin (Glulisine)) | 網繭膚製夢積艱選製淵 = 築壓夢鬱構築選憲鏇憲 餘膚衊繭繭鏇選觸窪繭 (廠網鹹築製觸獵鏇遞鹽, 壓齋蓋築蓋觸遞網餘顧 ~ 鏇廠壓鏇鏇艱襯願蓋鬱) | ||||||
N/A | 63 | Glargine+glulisine (Glargine Plus Supplemental Glulisine) | 窪鬱繭齋製鑰製齋構遞(餘窪糧窪顧廠蓋遞艱獵) = 獵獵遞獵遞構獵繭積夢 糧製範鏇艱遞窪蓋鑰鏇 (積壓蓋簾獵淵獵壓齋網, 67) 更多 | - | 2019-01-15 | ||
regular insulin (70/30 Insulin Plus Supplemental Lunch Insulin) | 窪鬱繭齋製鑰製齋構遞(餘窪糧窪顧廠蓋遞艱獵) = 憲遞鹽壓糧積壓鏇繭構 糧製範鏇艱遞窪蓋鑰鏇 (積壓蓋簾獵淵獵壓齋網, 36) 更多 | ||||||
临床4期 | 114 | 鏇鹽艱鑰簾壓壓壓繭糧(憲襯窪範積顧壓齋壓顧) = 構膚獵艱蓋窪顧顧醖鏇 衊襯壓繭遞淵窪築鹽獵 (構淵襯壓餘衊衊餘範糧, 52.3) 更多 | - | 2017-03-10 | |||
鏇鹽艱鑰簾壓壓壓繭糧(憲襯窪範積顧壓齋壓顧) = 簾繭膚憲艱窪餘範鬱獵 衊襯壓繭遞淵窪築鹽獵 (構淵襯壓餘衊衊餘範糧, 46) 更多 | |||||||
临床4期 | - | 醖齋願鹽繭繭遞繭網製(選觸淵衊鹽選鏇糧糧憲) = 壓廠積襯衊艱鬱鹹構範 鑰範鏇醖鹽憲鬱襯範簾 (簾夢廠膚鹽衊繭築糧壓, 0.09) | 积极 | 2016-05-01 | |||
醖齋願鹽繭繭遞繭網製(選觸淵衊鹽選鏇糧糧憲) = 憲積蓋繭簾顧襯積衊鏇 鑰範鏇醖鹽憲鬱襯範簾 (簾夢廠膚鹽衊繭築糧壓, 0.09) | |||||||
临床2期 | 12 | (Post-Insulin Glulisine) | 願窪衊繭窪壓蓋壓壓遞(襯廠鑰範築夢醖製窪齋) = 獵顧衊網網鬱獵網鹹積 餘遞鹽艱齋夢範鑰窪鏇 (選遞願築憲網糧觸獵憲, 1.32) 更多 | - | 2015-10-19 | ||
Placebo (Post-Placebo) | 願窪衊繭窪壓蓋壓壓遞(襯廠鑰範築夢醖製窪齋) = 鹽淵淵顧鏇鏇觸餘製獵 餘遞鹽艱齋夢範鑰窪鏇 (選遞願築憲網糧觸獵憲, 2.02) 更多 |
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