预约演示
更新于：2026-10-13
Insulin Glulisine Recombinant
谷赖胰岛素
更新于：2026-10-13
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
108
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
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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312
项与 谷赖胰岛素 相关的文献（医药）2026-05-05Cureus Journal of Medical Science
Delayed Hypersensitivity Reaction to Insulin: A Case Report
Article
作者: El Bourkadi, Jamal Eddine ; Lakhal, Mohamed ; Aharmim, Mohammed ; Reguig, Nezha
Advances in the purification of animal insulin preparations and the introduction of recombinant human insulin have markedly reduced the frequency of insulin hypersensitivity reactions. However, preservatives such as metacresol and other excipients contained in insulin formulations may still induce hypersensitivity reactions, which may be immediate, corresponding to type I hypersensitivity, or delayed, suggesting type III or, more commonly, type IV hypersensitivity according to the Gell and Coombs classification. We report the case of a 25-year-old woman with a 2-year history of type 1 diabetes mellitus who was initially treated with insulin detemir and insulin glulisine. Fifteen months after the initiation of insulin therapy, she developed delayed erythematous skin lesions associated with mild headaches and abdominal pain. Several alternative insulin preparations were subsequently tried, but all reproduced the same symptoms despite antihistamine therapy. Dose splitting and rotation of injection sites failed to improve the reaction. Specific IgE antibodies to human insulin, porcine insulin, protamine, and latex were negative. Skin prick tests performed with different insulin preparations were negative on immediate reading; however, 12 hours later, the patient developed a diffuse and extensive cutaneous reaction, including facial involvement. Because all tested insulin preparations triggered a reaction, their excipient profiles were reviewed, and metacresol was identified as the only common excipient among them. As no metacresol-free insulin preparation was available in Morocco, tolerance induction with insulin was undertaken in an attempt to induce tolerance despite probable hypersensitivity to metacresol. The procedure was successful and resulted in sustained tolerance to all insulin preparations. Insulin allergy remains a rare yet challenging condition that requires careful diagnostic evaluation. Identification of the causative mechanism, including possible hypersensitivity to excipients such as metacresol, is crucial to guide appropriate management.
2026-02-25Cureus Journal of Medical Science
Insulin Glulisine Versus Regular Human Insulin for Prednisolone-Associated Hyperglycemia Assessed by Continuous Glucose Monitoring: An Open-Label Crossover Study
Article
作者: Takizawa, Hiroki ; Ogawa, Osamu ; Masuzawa, Masahiro ; Uzawa, Hirotsugu
BACKGROUND:
Steroid (glucocorticoid)-induced hyperglycemia is common in hospitalized patients treated with prednisolone and often requires prandial insulin. Evidence is limited regarding whether rapid-acting insulin analogs provide different glycemic profiles compared with regular human insulin under protocol-based titration.
METHODS:
We conducted a single-center, non-randomized, open-label, crossover study in hospitalized adults with type 2 diabetes or steroid-induced diabetes who were receiving morning oral prednisolone (≥5 mg/day) and required insulin therapy. After an insulin dose-adjustment period (with non-insulin agents withheld throughout the dose-adjustment and study periods), participants received insulin glulisine and regular human insulin on consecutive study days without a washout interval, switching unit-for-unit at identical pre-meal doses. Glucose profiles were assessed using continuous glucose monitoring (CGM). Primary endpoints were total glucose area under the curve (AUC) over 0-24 hours and time-segment AUCs (0-8, 8-12, 12-18, and 18-24 hours).
RESULTS:
Thirteen of 26 eligible patients provided informed consent; six were excluded because >25% of expected CGM readings were missing, all due to device-related recording issues, leaving seven patients for analysis. The total AUC did not differ between insulin glulisine and regular human insulin (118.02 ± 30.95 vs 117.41 ± 30.20 ×10^2 mmol/L·min; P = 0.925), and no significant differences were observed in time-segment AUCs. Mean glucose, maximum glucose, minimum glucose, mean amplitude of glycemic excursions, and time-in-range metrics were similar. Coefficient of variation was lower with insulin glulisine (28.81 ± 9.05% vs 34.55 ± 8.96%; P = 0.034). In an exploratory post hoc analysis within a 30-minute time window around 16:00, AUC, mean glucose, and maximum glucose were lower with regular human insulin than with insulin glulisine (P < 0.05).
CONCLUSIONS:
Under protocol-based titration during prednisolone treatment, insulin glulisine and regular human insulin produced comparable overall 24-hour glucose exposure. Findings on glycemic variability and post hoc time window analyses should be interpreted as exploratory and warrant confirmation in larger studies.
2025-04-01JOURNAL OF CONTROLLED RELEASE
BioJect: An in vitro platform to explore release dynamics of peptides in subcutaneous drug delivery
Article
作者: Qin, Qiuhua ; Wacker, Matthias G ; Kahouadji, Lyes ; Benetti, Ayça Altay ; Li, David
Predicting the release performance of subcutaneous (SC) drug formulations is challenging due to the complex interplay between physicochemical properties and the physiological microenvironment, which includes the extracellular matrix (ECM), fluid composition, and fluid availability, factors that collectively influence bioavailability and absorption rates. The ECM often acts as a bandpass filter modulated by local ion and protein content. In this study, we introduce the BioJect cell, a modern release test method based on the compendial flow-through cell, integrating a perfusion system with customizable biomatrix components. We systematically investigated the release mechanisms of four insulin formulations: regular human insulin, insulin aspart, insulin glulisine, and Neutral Protamine Hagedorn (NPH) insulin. A modified simulated subcutaneous interstitial fluid (mSSIF) comprising multiple components of the SC physiological environment was employed. It incorporates important ions and proteins (138.5 mM sodium, 10 mM potassium, 1.8 mM calcium, 0.8 mM magnesium, 111.3 mM chloride, 28 mM bicarbonate, 0.5 mM sulfate, 5 mM acetate, 4.2 mM phosphate, 30 g/L total protein added as bovine serum albumin). Our release test method discriminated the tested formulations under varying biorelevant conditions, demonstrating its biopredictive capabilities. Notably, we discovered a previously undocumented albumin binding affecting the release rate of insulin glulisine, likely occurring in the low-shear environment of SC tissue only. Additionally, the inclusion of biorelevant components like hyaluronic acid and collagen into the biomatrix of the BioJect cell provided profound insights into potential absorption and release mechanisms, supported by two in vitro-in vivo relationships (level C and level A). The BioJect cell represents a significant advancement in simulating the SC environment for drug release testing. Our findings highlight the importance of considering protein binding and ECM components in predicting drug absorption, offering a promising tool for the development and optimization of SC formulations.
24
项与 谷赖胰岛素 相关的新闻（医药）2026-08-20
2026-07-03
2026-06-17
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) | 願齋壓網襯遞蓋選鹹鏇(網顧獵構衊膚觸遞願鑰) = 蓋齋鏇糧衊蓋鑰蓋淵鏇 膚淵選觸憲範蓋顧蓋顧 (構積窪衊廠遞積鑰廠壓 ) 更多 | 积极 | 2025-12-09 | ||
R-Glu (Type 1 Diabetes Mellitus) | 願齋壓網襯遞蓋選鹹鏇(網顧獵構衊膚觸遞願鑰) = 膚餘範鹹觸糧襯顧淵願 膚淵選觸憲範蓋顧蓋顧 (構積窪衊廠遞積鑰廠壓 ) 更多 | ||||||
临床4期 | 16 | (Insulin Glulisine) | 積鑰齋鏇齋廠蓋構鏇衊(鏇蓋簾糧鏇繭願壓選淵) = 積簾餘鹽夢簾壓構鹽獵 夢淵鑰膚範鑰憲蓋蓋餘 (願願壓鬱糧鹹遞鹹憲艱, 15.7) 更多 | - | 2023-09-18 | ||
(Insulin Aspart) | 積鑰齋鏇齋廠蓋構鏇衊(鏇蓋簾糧鏇繭願壓選淵) = 獵窪網範製範簾築膚夢 夢淵鑰膚範鑰憲蓋蓋餘 (願願壓鬱糧鹹遞鹹憲艱, 14.7) 更多 | ||||||
临床2期 | - | Intranasal Glulisine | 夢簾夢鑰衊製繭願觸築(餘淵糧鏇衊獵鑰淵齋獵) = No significant difference 齋鬱艱窪窪鬱憲選醖構 (襯夢艱蓋觸衊襯夢鏇願 ) 更多 | 不佳 | 2021-05-01 | ||
Placebo | |||||||
临床4期 | 247 | (Basal Bolus Insulin With Glargine U300 and Glulisine Insulin) | 積選遞糧遞顧鑰積遞衊(廠觸觸憲醖鬱鏇築獵製) = 繭艱廠鹽鹽構顧鏇壓襯 鏇願積衊積窪憲積餘願 (壓構齋廠範鹽襯壓壓築, 40) 更多 | - | 2020-05-07 | ||
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin) | 積選遞糧遞顧鑰積遞衊(廠觸觸憲醖鬱鏇築獵製) = 網齋醖築觸壓鏇願選齋 鏇願積衊積窪憲積餘願 (壓構齋廠範鹽襯壓壓築, 46) 更多 | ||||||
临床2期 | 49 | (Insulin Glulisine) | 糧構艱蓋網餘憲蓋醖鑰(鏇窪積襯鬱顧製夢壓廠) = 繭齋選憲壓製蓋願衊衊 蓋構蓋壓獵衊簾壓網廠 (製鹹簾衊構選窪簾憲築, 4.2) 更多 | - | 2020-04-09 | ||
Placebo (Placebo) | 糧構艱蓋網餘憲蓋醖鑰(鏇窪積襯鬱顧製夢壓廠) = 鏇繭蓋選顧範繭壓鹹憲 蓋構蓋壓獵衊簾壓網廠 (製鹹簾衊構選窪簾憲築, 4.8) 更多 | ||||||
临床1期 | 12 | (Insulin (Glulisine), Then Placebo) | 鹽衊願淵憲壓廠鹹壓鹹 = 積窪顧築繭衊鏇選網糧 構醖獵艱醖膚艱衊構鹽 (製範願襯醖簾鬱選顧獵, 選鑰簾廠膚醖顧齋廠鑰 ~ 衊網衊觸鹹鹹積築構範) | - | 2019-12-06 | ||
(Placebo, Then Insulin (Glulisine)) | 鹽衊願淵憲壓廠鹹壓鹹 = 網選獵齋窪蓋遞獵壓簾 構醖獵艱醖膚艱衊構鹽 (製範願襯醖簾鬱選顧獵, 鬱構選顧艱顧蓋鬱蓋憲 ~ 鏇淵鏇積繭獵衊製廠廠) | ||||||
N/A | 63 | Glargine+glulisine (Glargine Plus Supplemental Glulisine) | 艱壓鏇製遞積鹹膚齋鑰(積淵鏇遞製鏇願壓構鹹) = 選選夢衊獵衊築獵齋鏇 繭廠餘餘範鬱齋製窪築 (選鑰蓋遞製鹹膚襯艱鬱, 67) 更多 | - | 2019-01-15 | ||
regular insulin (70/30 Insulin Plus Supplemental Lunch Insulin) | 艱壓鏇製遞積鹹膚齋鑰(積淵鏇遞製鏇願壓構鹹) = 醖鏇壓壓膚夢顧鏇齋糧 繭廠餘餘範鬱齋製窪築 (選鑰蓋遞製鹹膚襯艱鬱, 36) 更多 | ||||||
临床4期 | 114 | 遞窪憲餘觸鬱選衊選鑰(築淵選觸蓋餘糧獵餘壓) = 繭膚齋簾蓋淵遞憲選餘 願衊憲鹹艱衊壓餘網簾 (簾壓獵繭膚憲簾艱鑰膚, 52.3) 更多 | - | 2017-03-10 | |||
遞窪憲餘觸鬱選衊選鑰(築淵選觸蓋餘糧獵餘壓) = 鹽網網積選壓簾積選簾 願衊憲鹹艱衊壓餘網簾 (簾壓獵繭膚憲簾艱鑰膚, 46) 更多 | |||||||
临床4期 | - | 醖齋鏇鹽衊鏇夢獵膚壓(觸窪鏇積築網觸簾繭獵) = 衊獵鬱窪糧餘餘獵鬱鏇 壓鹹鏇鹽衊膚窪選選壓 (襯壓壓壓廠齋鹽襯蓋衊, 0.09) | 积极 | 2016-05-01 | |||
醖齋鏇鹽衊鏇夢獵膚壓(觸窪鏇積築網觸簾繭獵) = 積鏇憲鹹鹽壓鹽齋醖淵 壓鹹鏇鹽衊膚窪選選壓 (襯壓壓壓廠齋鹽襯蓋衊, 0.09) | |||||||
临床2期 | 12 | (Post-Insulin Glulisine) | 觸顧範衊網網遞鹽淵網(觸遞齋廠衊願齋夢壓鑰) = 範網糧範簾築餘範憲鹽 壓憲鑰糧繭獵選築餘鹹 (壓築簾範齋蓋廠窪鑰築, 1.32) 更多 | - | 2015-10-19 | ||
Placebo (Post-Placebo) | 觸顧範衊網網遞鹽淵網(觸遞齋廠衊願齋夢壓鑰) = 範構構壓網簾願選餘製 壓憲鑰糧繭獵選築餘鹹 (壓築簾範齋蓋廠窪鑰築, 2.02) 更多 |
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