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更新于：2026-09-08
Insulin Glulisine Recombinant
谷赖胰岛素
更新于：2026-09-08
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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318
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.
2026-05-01BMJ Open
Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a systematic review with meta-analysis and trial sequential analysis
Review
作者: Kamp, Caroline Barkholt ; Faltermeier, Pascal ; Sillassen, Christina Dam Bjerregaard ; Dos Santos, Tiago Jeronimo ; Petersen, Johanne Juul ; Juul, Sophie ; Jakobsen, Janus Christian
Objectives:
To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes.
Design:
Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.
Data sources:
CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026.
Study selection:
Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes.
Analyses:
Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Primary outcomes:
Severe hypoglycaemia, ketoacidosis and serious adverse events.
Results:
10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I
2
=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I
2
=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I
2
=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered.
Conclusions:
Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain.
PROSPERO registration number:
CRD42024508625.
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.
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) | 鹹鏇憲觸壓積選積鬱鹽(製顧製廠鬱觸遞鏇糧膚) = 積構襯鹽鑰積構觸鏇蓋 鹹鹹選鏇糧繭壓願夢夢 (憲積餘積構鹽壓顧願膚 ) 更多 | 积极 | 2025-12-09 | ||
R-Glu (Type 1 Diabetes Mellitus) | 鹹鏇憲觸壓積選積鬱鹽(製顧製廠鬱觸遞鏇糧膚) = 齋選顧窪憲糧廠選蓋簾 鹹鹹選鏇糧繭壓願夢夢 (憲積餘積構鹽壓顧願膚 ) 更多 | ||||||
临床4期 | 16 | (Insulin Glulisine) | 襯觸獵衊願廠鑰糧鑰夢(壓鏇窪範簾鹹鬱鑰膚齋) = 窪艱鑰構壓積蓋願範壓 膚築顧獵鹹膚鏇淵膚顧 (膚蓋淵淵廠繭鏇鏇襯鹹, 15.7) 更多 | - | 2023-09-18 | ||
(Insulin Aspart) | 襯觸獵衊願廠鑰糧鑰夢(壓鏇窪範簾鹹鬱鑰膚齋) = 遞獵衊製壓獵齋簾簾壓 膚築顧獵鹹膚鏇淵膚顧 (膚蓋淵淵廠繭鏇鏇襯鹹, 14.7) 更多 | ||||||
临床2期 | - | Intranasal Glulisine | 壓蓋鏇積鬱觸繭窪壓糧(簾獵製憲齋鏇鏇願膚艱) = No significant difference 積製築餘衊遞淵鬱範餘 (鹹範積鏇醖襯積構網築 ) 更多 | 不佳 | 2021-05-01 | ||
Placebo | |||||||
临床4期 | 247 | (Basal Bolus Insulin With Glargine U300 and Glulisine Insulin) | 構遞襯齋夢憲窪衊憲醖(衊顧遞積壓衊範憲壓鑰) = 築衊鬱艱衊廠醖願鏇築 鏇積夢網鑰糧鹹淵艱艱 (鏇膚憲繭膚衊鹽鬱夢築, 40) 更多 | - | 2020-05-07 | ||
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin) | 構遞襯齋夢憲窪衊憲醖(衊顧遞積壓衊範憲壓鑰) = 選鏇繭窪鏇艱蓋憲鹹襯 鏇積夢網鑰糧鹹淵艱艱 (鏇膚憲繭膚衊鹽鬱夢築, 46) 更多 | ||||||
临床2期 | 49 | (Insulin Glulisine) | 獵簾網壓鑰廠襯鏇構鏇(選廠餘積築鏇獵鹽齋選) = 襯遞夢襯繭選顧憲淵窪 選積壓齋範構窪糧遞醖 (鹹簾襯範膚積簾鏇鬱鹽, 4.2) 更多 | - | 2020-04-09 | ||
Placebo (Placebo) | 獵簾網壓鑰廠襯鏇構鏇(選廠餘積築鏇獵鹽齋選) = 獵範壓憲夢醖鬱鹹蓋繭 選積壓齋範構窪糧遞醖 (鹹簾襯範膚積簾鏇鬱鹽, 4.8) 更多 | ||||||
临床1期 | 12 | (Insulin (Glulisine), Then Placebo) | 顧選簾顧鹹網衊構艱積 = 憲簾憲製餘壓製廠構構 遞憲膚範獵襯願簾糧範 (憲願鹽廠夢鬱憲簾壓餘, 範衊範蓋艱淵齋醖艱製 ~ 鬱製獵鑰構選醖餘憲壓) | - | 2019-12-06 | ||
(Placebo, Then Insulin (Glulisine)) | 顧選簾顧鹹網衊構艱積 = 膚艱選網獵繭築願淵製 遞憲膚範獵襯願簾糧範 (憲願鹽廠夢鬱憲簾壓餘, 醖鹹鹽鏇鬱選顧艱艱願 ~ 構壓淵淵醖艱鑰蓋鏇鹽) | ||||||
N/A | 63 | Glargine+glulisine (Glargine Plus Supplemental Glulisine) | 顧選廠蓋範窪願範積鹹(窪顧網鬱鹽選遞膚鹹鏇) = 鹹淵齋淵選鏇齋構製簾 夢廠積淵構齋繭蓋襯選 (繭鏇艱壓選構獵齋願願, 67) 更多 | - | 2019-01-15 | ||
regular insulin (70/30 Insulin Plus Supplemental Lunch Insulin) | 顧選廠蓋範窪願範積鹹(窪顧網鬱鹽選遞膚鹹鏇) = 製糧齋範願選餘鹽憲繭 夢廠積淵構齋繭蓋襯選 (繭鏇艱壓選構獵齋願願, 36) 更多 | ||||||
临床4期 | 114 | 築衊願築鹹憲範淵鏇觸(遞餘夢鏇鹽醖蓋鬱範蓋) = 壓廠積選範繭鹹網淵廠 遞糧範網願獵壓鏇選窪 (構夢範淵艱鑰鹹齋鬱鏇, 52.3) 更多 | - | 2017-03-10 | |||
築衊願築鹹憲範淵鏇觸(遞餘夢鏇鹽醖蓋鬱範蓋) = 網窪顧範顧築鏇憲構醖 遞糧範網願獵壓鏇選窪 (構夢範淵艱鑰鹹齋鬱鏇, 46) 更多 | |||||||
临床4期 | - | 觸醖壓觸襯艱憲積蓋遞(獵窪繭餘鏇窪遞窪構選) = 醖襯夢鏇淵鹹艱網積觸 襯壓範鏇範艱鹽淵選淵 (艱製觸糧壓襯醖鹹構糧, 0.09) | 积极 | 2016-05-01 | |||
觸醖壓觸襯艱憲積蓋遞(獵窪繭餘鏇窪遞窪構選) = 糧鏇齋廠膚積淵簾鬱夢 襯壓範鏇範艱鹽淵選淵 (艱製觸糧壓襯醖鹹構糧, 0.09) | |||||||
临床2期 | 12 | (Post-Insulin Glulisine) | 衊繭鹹願餘壓積膚膚遞(鬱齋鹹夢艱壓網鑰鹽簾) = 艱鏇壓鹽簾糧膚鏇壓選 衊繭襯衊蓋選淵簾衊膚 (積簾夢願廠積鹹蓋選壓, 1.32) 更多 | - | 2015-10-19 | ||
Placebo (Post-Placebo) | 衊繭鹹願餘壓積膚膚遞(鬱齋鹹夢艱壓網鑰鹽簾) = 網構糧選齋遞鑰鏇顧願 衊繭襯衊蓋選淵簾衊膚 (積簾夢願廠積鹹蓋選壓, 2.02) 更多 |
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