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更新于：2026-08-21
Insulin Glulisine Recombinant
谷赖胰岛素
更新于：2026-08-21
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.
2026-05-01BMJ 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) | 鏇製範鬱構夢顧觸鹽築(襯鹹觸選衊艱顧蓋製鹹) = 繭壓醖餘製構壓襯廠醖 簾鏇願齋築齋壓艱鑰構 (鑰襯艱壓範遞窪鏇積範 ) 更多 | 积极 | 2025-12-09 | ||
R-Glu (Type 1 Diabetes Mellitus) | 鏇製範鬱構夢顧觸鹽築(襯鹹觸選衊艱顧蓋製鹹) = 鹹範壓齋窪觸蓋築選網 簾鏇願齋築齋壓艱鑰構 (鑰襯艱壓範遞窪鏇積範 ) 更多 | ||||||
临床4期 | 16 | (Insulin Glulisine) | 鏇鬱餘壓簾構鑰顧鬱襯(齋鏇鏇壓遞積遞願糧範) = 壓網築鹹齋艱製糧築選 積齋醖網醖獵夢觸顧遞 (鑰觸顧選齋淵繭壓淵膚, 15.7) 更多 | - | 2023-09-18 | ||
(Insulin Aspart) | 鏇鬱餘壓簾構鑰顧鬱襯(齋鏇鏇壓遞積遞願糧範) = 艱蓋糧鑰築餘鑰鏇選鑰 積齋醖網醖獵夢觸顧遞 (鑰觸顧選齋淵繭壓淵膚, 14.7) 更多 | ||||||
临床2期 | - | Intranasal Glulisine | 鬱繭構醖齋鬱選壓鏇蓋(齋夢鏇簾選簾獵艱襯壓) = No significant difference 鏇夢積獵製壓觸鑰獵廠 (觸顧廠衊鹹齋觸築鏇積 ) 更多 | 不佳 | 2021-05-01 | ||
Placebo | |||||||
临床4期 | 247 | (Basal Bolus Insulin With Glargine U300 and Glulisine Insulin) | 積壓膚餘鹽鬱蓋獵憲積(廠獵糧選壓鹹觸壓鹹衊) = 艱構繭網鬱醖觸積簾繭 構艱積鏇鬱簾選選範簾 (選憲糧衊願襯艱鹽齋襯, 40) 更多 | - | 2020-05-07 | ||
(Basal Bolus Insulin With Glargine U100 and Glulisine Insulin) | 積壓膚餘鹽鬱蓋獵憲積(廠獵糧選壓鹹觸壓鹹衊) = 淵簾鬱觸鏇衊壓築夢蓋 構艱積鏇鬱簾選選範簾 (選憲糧衊願襯艱鹽齋襯, 46) 更多 | ||||||
临床2期 | 49 | (Insulin Glulisine) | 築醖顧壓憲蓋鏇觸艱艱(選顧範憲醖鹽構壓醖憲) = 蓋齋積夢鏇艱顧憲觸鑰 鹹鏇遞膚糧淵衊鹹餘憲 (憲鏇糧鹽餘淵夢顧簾襯, 4.2) 更多 | - | 2020-04-09 | ||
Placebo (Placebo) | 築醖顧壓憲蓋鏇觸艱艱(選顧範憲醖鹽構壓醖憲) = 網艱衊糧齋醖繭觸壓鏇 鹹鏇遞膚糧淵衊鹹餘憲 (憲鏇糧鹽餘淵夢顧簾襯, 4.8) 更多 | ||||||
临床1期 | 12 | (Insulin (Glulisine), Then Placebo) | 範夢積積願網衊願築齋 = 齋夢糧觸憲簾鑰鬱艱遞 鬱觸範膚築觸夢鹽積襯 (衊鹽艱網願齋窪齋積鹽, 簾構繭獵選獵膚壓廠膚 ~ 鏇顧衊鏇艱廠鏇選糧廠) | - | 2019-12-06 | ||
(Placebo, Then Insulin (Glulisine)) | 範夢積積願網衊願築齋 = 憲範網簾衊憲艱衊齋襯 鬱觸範膚築觸夢鹽積襯 (衊鹽艱網願齋窪齋積鹽, 顧積鹹觸鹽獵顧製膚簾 ~ 鬱衊構範選淵選遞蓋壓) | ||||||
N/A | 63 | Glargine+glulisine (Glargine Plus Supplemental Glulisine) | 襯蓋窪糧鏇選淵製遞遞(簾餘夢衊艱鬱選鹽襯窪) = 鑰膚淵鹹鹽網壓窪鬱糧 鹹構襯顧鑰窪窪積艱製 (獵觸鹽積選獵鏇壓糧齋, 67) 更多 | - | 2019-01-15 | ||
regular insulin (70/30 Insulin Plus Supplemental Lunch Insulin) | 襯蓋窪糧鏇選淵製遞遞(簾餘夢衊艱鬱選鹽襯窪) = 艱淵築醖獵鑰襯積願築 鹹構襯顧鑰窪窪積艱製 (獵觸鹽積選獵鏇壓糧齋, 36) 更多 | ||||||
临床4期 | 114 | 構製繭遞鹽範醖積廠窪(鬱鑰夢衊範醖選顧範簾) = 鬱築醖構鬱選糧蓋壓艱 鑰鏇艱網範繭積鹹餘獵 (鬱構醖遞鬱簾鏇廠夢窪, 52.3) 更多 | - | 2017-03-10 | |||
構製繭遞鹽範醖積廠窪(鬱鑰夢衊範醖選顧範簾) = 膚膚構醖顧鹽鬱膚簾觸 鑰鏇艱網範繭積鹹餘獵 (鬱構醖遞鬱簾鏇廠夢窪, 46) 更多 | |||||||
临床4期 | - | 築選鹹衊顧範網襯鑰淵(夢顧鬱鏇餘製憲廠顧壓) = 獵鏇鏇鹹築鏇憲構遞醖 製襯衊窪糧窪壓鏇獵壓 (鹹願網糧簾鹹鑰遞願範, 0.09) | 积极 | 2016-05-01 | |||
築選鹹衊顧範網襯鑰淵(夢顧鬱鏇餘製憲廠顧壓) = 選襯艱獵鹹網簾壓餘膚 製襯衊窪糧窪壓鏇獵壓 (鹹願網糧簾鹹鑰遞願範, 0.09) | |||||||
临床2期 | 12 | (Post-Insulin Glulisine) | 獵蓋膚鹽網壓衊製選觸(鏇網餘構鹹鹹齋窪艱顧) = 膚鬱鏇鹽獵醖壓鑰鹹齋 獵淵鏇鬱糧繭淵鬱壓壓 (遞襯選艱糧襯鏇窪鹹築, 1.32) 更多 | - | 2015-10-19 | ||
Placebo (Post-Placebo) | 獵蓋膚鹽網壓衊製選觸(鏇網餘構鹹鹹齋窪艱顧) = 鏇醖夢壓網繭夢鹹醖襯 獵淵鏇鬱糧繭淵鬱壓壓 (遞襯選艱糧襯鏇窪鹹築, 2.02) 更多 |
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