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更新于：2025-05-08
Insulin glargine (Sanofi)
甘精胰岛素
更新于：2025-05-08
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
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最高研发阶段(中国)批准上市 |
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结构/序列
Sequence Code 4851
来源: *****
Sequence Code 31960
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关联
188
项与 甘精胰岛素 相关的临床试验CTRI/2025/04/085669
Comparative Efficacy and Safety of Glargine With Short-Acting Analog Versus NPH With Short-Acting Analog in Pulse Steroid Therapy-Induced Hyperglycemia - NIL
CTRI/2024/09/074053
EFFICACY OF EARLY GLARGINE PLUS STANDARD IV INSULIN VERSUS STANDARD IV INSULIN IN PATIENTS WITH DIABETIC KETOACIDOSIS: A RANDOMISED CONTROLLED TRIAL - NIL
NCT06881264
A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)
100 项与 甘精胰岛素 相关的临床结果
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100 项与 甘精胰岛素 相关的转化医学
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100 项与 甘精胰岛素 相关的专利（医药）
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3,323
项与 甘精胰岛素 相关的文献（医药）2025-06-01DIABETES OBESITY & METABOLISM
Time spent in glycaemic control with sustained body weight reduction with tirzepatide: A post hoc analysis of the SURPASS clinical trial programme
Article
作者: Thieu, Vivian T. ; Batterham, Rachel L. ; Liu, Minzhi ; Rosenstock, Julio ; Chen, Yanyun ; Bergman, Brandon K. ; Karanikas, Chrisanthi A. ; Garvey, W. Timothy ; Sharma, Palash
Abstract:
Aims:
This participant‐level exploratory analysis assessed the continuous time spent in glycaemic control and/or with sustained weight reductions with tirzepatide treatment in participants with type 2 diabetes (T2D) from the SURPASS programme.
Materials and Methods:
Participants (N = 6246) from SURPASS 1–5 were randomized to once weekly tirzepatide (5, 10 or 15 mg) or comparator (once weekly placebo, once weekly semaglutide 1 mg, insulin degludec or insulin glargine). Continuous time spent with HbA1c < 7.0% (53 mmol/mol), ≤6.5% (48 mmol/mol) and ≥5% body weight reduction and combined HbA1c ≤ 6.5% (48 mmol/mol) with a ≥5% body weight reduction were assessed through 40 weeks (SURPASS‐1, ‐2, and ‐5) or 52 weeks (SURPASS‐3 and ‐4). The non‐parametric Wilcoxon rank sum test was used to compare the median duration of continuous time spent in control, and logistic regression was used to analyse the proportion of participants achieving glycaemic control and body weight reduction at any time points or at the end of the primary study period.
Results:
Median time spent with HbA1c < 7.0% (53 mmol/mol) was 80% (tirzepatide) versus 70% (semaglutide) and 0% (placebo) of the treatment duration in 40‐week studies, and 77%–85% (tirzepatide) versus 62% (insulin degludec) and 23% (insulin glargine) of the treatment duration in 52‐week studies (p < 0.001). Time spent with HbA1c < 7.0% (53 mmol/mol) was generally similar across all tirzepatide doses in each study. Dose‐dependent increases in time spent with ≥5% body weight reduction were observed with tirzepatide (median time spent: 20%–77% with tirzepatide versus 25% with semaglutide 1 mg) (p < 0.001). Tirzepatide‐treated participants experienced longer time spent with HbA1c ≤ 6.5% (48 mmol/mol) and ≥5% body weight reduction versus semaglutide (median: 35%–60% vs. 7%) (p < 0.001).
Conclusions:
In this post hoc analysis, people with T2D experienced substantially longer continuous time in glycaemic control and more sustained body weight reductions with tirzepatide versus placebo and active comparators.
2025-06-01DIABETES OBESITY & METABOLISM
Efficacy and safety of iGlarLixi versus IDegAsp in people with type 2 diabetes inadequately controlled with basal insulin: A systematic literature review and network meta‐analysis of non‐Asian studies
Review
作者: Hafidh, Khadija ; Mehta, Roopa ; Faraoun, Khadra ; Li, Xuan‐Tony ; Anaforoğlu, İnan ; Djaballah, Khier ; Home, Philip ; Lauand, Felipe ; Serafini, Paul ; Pourrahmat, Mir‐Masoud
Abstract:
Aims:
To estimate the relative treatment effect of iGlarLixi (a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide) versus premixed insulin IDegAsp (insulin degludec plus insulin aspart) in people with type 2 diabetes (T2D) who advanced from basal insulin to iGlarLixi or IDegAsp in non‐Asian studies.
Materials and Methods:
Randomized controlled trials (RCTs) were identified in a systematic review by searching Embase (including congress abstracts from 2021 to 2023), MEDLINE® and CENTRAL on 10 October 2023. Treatment outcomes from non‐Asian RCTs for people with T2D previously treated with basal insulin, who switched to iGlarLixi or IDegAsp, were compared using a network meta‐analysis (NMA). Data analysis was performed using R, version 4.0.2.
Results:
The NMA included four RCTs (N = 2535). The results of the NMA showed that iGlarLixi (n = 810) was associated with a significantly greater reduction in HbA1c versus IDegAsp (n = 454) (mean difference [MD]: −0.39 [95% credible interval, CrI: −0.58, −0.21] %‐units). iGlarLixi was also associated with a significantly greater likelihood of achieving an HbA1c of <7.0% (risk ratio: 1.42, 95% CrI: 1.18, 1.71). A greater reduction in postprandial glucose was observed with iGlarLixi versus IDegAsp (MD: −1.38 [95% CrI: −2.15, −0.63] mmol/L). A body weight benefit that favoured iGlarLixi versus IDegAsp was documented (MD: −1.54 [95% CrI: −2.26, −0.84] kg). Hypoglycaemia evaluation was inconclusive due to definitional differences between trials.
Conclusions:
Once‐daily iGlarLixi was associated with superior blood glucose control and body weight benefit compared with IDegAsp in insulin‐experienced populations with T2D in non‐Asian RCTs.
2025-06-01DIABETES OBESITY & METABOLISM
An open‐label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability
Article
作者: Plum‐Moerschel, Leona ; Samsonraj, R. ; Loganathan, Subramanian ; Panda, Jayanti ; Murugesan, Sundara Moorthi Nainar ; Latres, Esther ; Lou, Olivia ; Gopu, C. L. ; Athalye, Sandeep Nilkanth ; Marwah, Ashwani
Abstract:
Aim:
This trial evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of oral insulin Tregopil (Part 1; results discussed in this paper) and the post‐prandial glucose control with different meal types in comparison with insulin aspart (Part 2) in patients with type 1 diabetes mellitus (T1DM).
Materials and Methods:
This Phase 1, open‐label, multiple ascending dose (30/45/60 mg/60 + 30 mg rescue insulin Tregopil) trial enrolled 37 patients with T1DM (3 female [8.1%], 34 male [91.9%]; median age: 39.5 years). Following screening, patients entered a run‐in phase to optimize their basal‐bolus (insulin glargine and insulin aspart) insulin therapy, and insulin Tregopil was administered orally 10 min before the three major meals of the day in all cohorts during this period. Safety assessments included adverse events and hypo−/hyperglycaemic episodes, vital signs, electrocardiograms, laboratory safety parameters and physical examination. PK and PD were the secondary objectives.
Results:
The overall safety profile of insulin Tregopil indicated no safety concerns except a PD effect (hypoglycaemia). The incidence of hypoglycaemia did not increase with increasing doses of insulin Tregopil, and none of the episodes were severe. In general, the variability of the PK/PD parameters was high. Insulin Tregopil demonstrated a rapid onset of action, with peak blood concentrations reached within 15–20 min post‐dosing. Subsequently, insulin Tregopil exerted a PD effect for up to 105 min.
Conclusion:
Fixed‐dose insulin Tregopil reduced the requirement for insulin aspart supplementation, although it was not a viable stand‐alone option for the daily management of T1DM. Insulin Tregopil could be explored with a flexible dosing approach and be titrated based on individual needs.
Trial Registration:
The trial is registered at Clinicaltrials.gov (CT.gov identifier: NCT04141423). The ethical approval number for the protocol is 2019146.
100 项与 甘精胰岛素 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 |
|---|---|---|---|
| 糖尿病 | 欧盟 | 2000-06-09 | |
| 糖尿病 | 冰岛 | 2000-06-09 | |
| 糖尿病 | 列支敦士登 | 2000-06-09 | |
| 糖尿病 | 挪威 | 2000-06-09 | |
| 1型糖尿病 | 美国 | 2000-04-20 | |
| 2型糖尿病 | 美国 | 2000-04-20 |
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
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NEWS 人工标引  | N/A | 568 | (初治) | 淵鏇遞淵範遞願獵觸觸(夢構築壓蓋範獵壓構鑰) = 膚獵蓋窪餘積鹹範艱獵 願築獵鏇齋憲淵憲鬱蓋 (築願齋選鹹範憲憲糧壓 ) 更多 | 积极 | 2024-11-19 | |
(基础胰岛素转换) | 淵鏇遞淵範遞願獵觸觸(夢構築壓蓋範獵壓構鑰) = 鹽鏇衊齋繭網繭齋顧窪 願築獵鏇齋憲淵憲鬱蓋 (築願齋選鹹範憲憲糧壓 ) 更多 | ||||||
临床4期 | - | Twice-daily basal insulin | 醖壓廠簾蓋鬱淵醖鑰網(構顧鹹廠願獵醖築獵窪) = 廠襯鏇顧鬱簾齋糧夢網 顧簾餘願醖鏇簾範鑰壓 (築醖鑰鏇繭鏇襯艱糧築 ) 更多 | 积极 | 2024-07-09 | ||
N/A | 11 | 夢窪製窪醖鹹獵觸衊簾(壓願鑰遞繭膚壓鬱憲夢) = 鹽觸餘鑰遞簾壓鹽壓網 艱襯衊膚遞範艱糧膚壓 (獵膚顧鹽糧淵選觸淵膚, ±76.9) | 积极 | 2024-04-01 | |||
Glargine insulin | 夢窪製窪醖鹹獵觸衊簾(壓願鑰遞繭膚壓鬱憲夢) = 糧艱襯鬱糧鹹膚鬱膚鏇 艱襯衊膚遞範艱糧膚壓 (獵膚顧鹽糧淵選觸淵膚, ±60.6) | ||||||
N/A | 412 | Insulin Glargine U300 (Gla-300) | 顧窪淵衊獵蓋窪窪鬱餘(選淵窪範窪觸膚獵醖積) = PROs improved 齋夢簾艱夢鏇簾顧糧獵 (獵餘鏇衊構鑰簾鬱構憲 ) 更多 | 积极 | 2024-03-01 | ||
临床4期 | 102 | 艱蓋糧遞築壓網遞顧範(鹽醖鏇網繭餘窪鑰鹽壓) = 觸範齋簾艱襯獵構醖廠 獵淵鹹廠餘願築鑰醖糧 (積醖蓋夢繭獵製憲積壓, 7.89) 更多 | - | 2023-12-29 | |||
N/A | 水肿 Anti-IA2 antibodies | - | 齋餘襯鹽鹽願襯醖遞襯(繭製夢廠膚範襯選遞齋) = Patient developed extensive 2+ pitting edema in bilateral feet extending up to his calves after initiating insulin glargine, which resolved within 3 days of switching to insulin degludec 膚膚蓋廠廠蓋觸遞觸壓 (鏇繭顧窪夢膚簾鬱鏇醖 ) | - | 2023-10-05 | ||
N/A | - | Insulin glargine 300 U/mL (Gla-300) | 廠鏇壓積網願憲糧壓遞(選衊淵網糧製鏇觸鏇壓) = 襯簾顧膚顧鬱壓鬱網繭 襯廠獵築願鬱築製廠鹽 (襯鬱鏇壓鬱網觸願齋積 ) | - | 2023-10-05 | ||
Long-acting basal insulins (BIs)/NPH insulin | 廠鏇壓積網願憲糧壓遞(選衊淵網糧製鏇觸鏇壓) = 遞鬱醖糧繭範構壓憲廠 襯廠獵築願鬱築製廠鹽 (襯鬱鏇壓鬱網觸願齋積 ) | ||||||
临床3期 | Sex hormone-binding globulin (SHBG) | testosterone | - | 淵淵鑰艱餘憲廠壓範衊(獵衊選選獵鹹廠鬱遞醖) = 選範範淵顧窪築衊鬱餘 鑰構鑰積鬱鏇築獵窪顧 (壓鏇膚築遞壓鏇觸繭願 ) | - | 2023-08-26 | ||
淵淵鑰艱餘憲廠壓範衊(獵衊選選獵鹹廠鬱遞醖) = 醖鏇遞鬱窪廠網廠齋顧 鑰構鑰積鬱鏇築獵窪顧 (壓鏇膚築遞壓鏇觸繭願 ) | |||||||
临床3期 | 210 | (Switching: NovoLog/SAR341402) | 獵鏇願襯衊構積獵簾遞(構憲鹽鹽積獵窪壓網簾) = 鏇鏇蓋鬱鹹顧鏇窪蓋艱 鹹淵齋膚獵鹽廠築願鹽 (醖糧糧製構醖鏇範鏇鹹, 18300) 更多 | - | 2023-07-21 | ||
(Non-switching: NovoLog) | 獵鏇願襯衊構積獵簾遞(構憲鹽鹽積獵窪壓網簾) = 衊鹹遞夢膚廠蓋鑰範遞 鹹淵齋膚獵鹽廠築願鹽 (醖糧糧製構醖鏇範鏇鹹, 6530) 更多 | ||||||
N/A | - | - | 窪蓋構鏇壓壓網廠憲願(積淵繭構鑰憲選齋鬱繭) = 襯構壓製齋選糧鹽簾衊 壓構積構廠鹽鬱艱淵遞 (蓋襯窪蓋餘壓築鑰蓋鹽 ) | - | 2023-06-23 |
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