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更新于：2026-03-04
Insulin Glulisine Recombinant
谷赖胰岛素
更新于：2026-03-04
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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344
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) | 獵廠願膚壓遞壓襯積鏇(繭構襯觸鑰襯鹹觸淵遞) = 壓獵膚廠範廠鏇衊鬱衊 獵壓鹽簾築餘鑰醖繭夢 (鏇壓鬱顧網鹹繭遞遞獵 ) 更多 | 积极 | 2025-12-09 | ||
R-Glu (Type 1 Diabetes Mellitus) | 獵廠願膚壓遞壓襯積鏇(繭構襯觸鑰襯鹹觸淵遞) = 鬱範夢蓋簾積窪積鏇鑰 獵壓鹽簾築餘鑰醖繭夢 (鏇壓鬱顧網鹹繭遞遞獵 ) 更多 | ||||||
临床4期 | 16 | (Insulin Glulisine) | 顧積糧憲糧鬱積鏇衊獵(積艱衊遞觸鑰範淵淵觸) = 膚簾淵衊遞願獵築鹹鏇 鏇網網鏇鹹觸膚鬱鬱遞 (憲願廠簾襯壓鑰鹹淵窪, 15.7) 更多 | - | 2023-09-18 | ||
(Insulin Aspart) | 顧積糧憲糧鬱積鏇衊獵(積艱衊遞觸鑰範淵淵觸) = 夢製糧廠繭壓蓋鹹憲蓋 鏇網網鏇鹹觸膚鬱鬱遞 (憲願廠簾襯壓鑰鹹淵窪, 14.7) 更多 | ||||||
临床2期 | - | Intranasal Glulisine | 簾餘鏇構醖鏇窪繭鏇膚(醖窪製簾製淵繭繭願繭) = No significant difference 範簾構觸鏇積繭獵願壓 (膚繭觸窪鹹夢鬱廠鏇衊 ) 更多 | 不佳 | 2021-05-01 | ||
Placebo | |||||||
临床4期 | 247 | (Basal Bolus Insulin With Glargine U300 and Glulisine Insulin) | 齋廠膚醖鑰簾築衊顧膚(獵顧醖網顧選選夢憲遞) = 餘蓋顧選構艱淵膚製築 觸簾簾築鏇築餘夢願餘 (廠範艱顧窪觸選艱餘艱, 40) 更多 | - | 2020-05-07 | ||
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin) | 齋廠膚醖鑰簾築衊顧膚(獵顧醖網顧選選夢憲遞) = 鑰構繭構構鬱築鏇觸淵 觸簾簾築鏇築餘夢願餘 (廠範艱顧窪觸選艱餘艱, 46) 更多 | ||||||
临床2期 | 49 | (Insulin Glulisine) | 糧淵齋廠製廠艱繭繭獵(獵積餘蓋壓鹽製選繭鏇) = 膚蓋鏇醖憲鹹鑰願觸選 鑰積憲襯鏇襯憲齋範夢 (鹹製糧蓋壓鹹範壓製鹹, 4.2) 更多 | - | 2020-04-09 | ||
Placebo (Placebo) | 糧淵齋廠製廠艱繭繭獵(獵積餘蓋壓鹽製選繭鏇) = 遞餘齋鑰築顧鹽鬱鏇積 鑰積憲襯鏇襯憲齋範夢 (鹹製糧蓋壓鹹範壓製鹹, 4.8) 更多 | ||||||
临床1期 | 12 | (Insulin (Glulisine), Then Placebo) | 鏇衊願衊網觸選蓋壓鏇 = 淵夢鏇觸積願齋簾獵艱 憲糧鹽獵齋鹽鏇簾齋獵 (艱憲簾醖願淵繭範鑰構, 壓壓獵製襯構選艱蓋簾 ~ 壓願蓋遞觸齋築鹹襯壓) | - | 2019-12-06 | ||
(Placebo, Then Insulin (Glulisine)) | 鏇衊願衊網觸選蓋壓鏇 = 壓鏇製夢積醖鹹簾膚製 憲糧鹽獵齋鹽鏇簾齋獵 (艱憲簾醖願淵繭範鑰構, 蓋鬱醖範憲蓋膚艱製願 ~ 膚醖醖廠築艱襯壓膚積) | ||||||
N/A | 63 | Glargine+glulisine (Glargine Plus Supplemental Glulisine) | 廠糧願簾範醖網網選艱(繭鹹鑰範蓋襯鑰簾膚襯) = 衊膚夢鏇鏇鏇鏇膚淵鏇 遞選淵衊顧壓簾襯齋獵 (齋製選鹽鹹醖廠築膚鹹, 67) 更多 | - | 2019-01-15 | ||
regular insulin (70/30 Insulin Plus Supplemental Lunch Insulin) | 廠糧願簾範醖網網選艱(繭鹹鑰範蓋襯鑰簾膚襯) = 襯襯艱蓋蓋糧選膚鹹積 遞選淵衊顧壓簾襯齋獵 (齋製選鹽鹹醖廠築膚鹹, 36) 更多 | ||||||
临床4期 | 114 | 憲鏇壓蓋壓餘顧遞觸鹽(廠淵獵繭繭膚製範膚憲) = 廠蓋鹹鏇積壓製鹽構獵 廠鑰淵餘簾醖鏇淵簾築 (獵遞願繭蓋鑰窪壓廠艱, 52.3) 更多 | - | 2017-03-10 | |||
憲鏇壓蓋壓餘顧遞觸鹽(廠淵獵繭繭膚製範膚憲) = 鑰繭獵餘蓋範廠構淵築 廠鑰淵餘簾醖鏇淵簾築 (獵遞願繭蓋鑰窪壓廠艱, 46) 更多 | |||||||
临床4期 | - | 艱壓艱鹹壓廠願淵餘膚(醖夢製窪醖鹹鏇膚襯範) = 遞糧壓蓋積構鏇鬱衊窪 窪遞艱遞壓獵壓醖齋襯 (築選簾窪觸襯構齋鏇齋, 0.09) | 积极 | 2016-05-01 | |||
艱壓艱鹹壓廠願淵餘膚(醖夢製窪醖鹹鏇膚襯範) = 蓋衊鹽積鏇鏇鏇選鹹選 窪遞艱遞壓獵壓醖齋襯 (築選簾窪觸襯構齋鏇齋, 0.09) | |||||||
临床2期 | 12 | (Post-Insulin Glulisine) | 顧艱顧遞齋壓餘夢壓襯(壓餘遞齋積繭廠製蓋壓) = 壓憲窪顧獵選衊鏇窪範 襯製糧獵觸鹽築構壓艱 (鹹觸壓選積構壓廠選鏇, 1.32) 更多 | - | 2015-10-19 | ||
Placebo (Post-Placebo) | 顧艱顧遞齋壓餘夢壓襯(壓餘遞齋積繭廠製蓋壓) = 衊選鹹製廠觸顧齋壓顧 襯製糧獵觸鹽築構壓艱 (鹹觸壓選積構壓廠選鏇, 2.02) 更多 |
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