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更新于：2026-02-07
Insulin Glargine/Lixisenatide
甘精胰岛素利司那肽
更新于：2026-02-07
概要
基本信息
药物类型 多肽激素 |
别名 AVE0010/Lantus、iGlarLixi、Insulin glargine/Lixisenatide + [13] |
作用方式 激动剂 |
作用机制 GLP-1R激动剂(胰高血糖素样肽-1激动剂)、INSR激动剂(胰岛素受体激动剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 瑞士 (2002-05-16), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
Sequence Code 4851β
Sequence Code 31960α
关联
28
项与 甘精胰岛素利司那肽 相关的临床试验NCT07307235
Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial
NCT07274644
Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus With Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial
NCT06716424
Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA
100 项与 甘精胰岛素利司那肽 相关的临床结果
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100 项与 甘精胰岛素利司那肽 相关的转化医学
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100 项与 甘精胰岛素利司那肽 相关的专利（医药）
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135
项与 甘精胰岛素利司那肽 相关的文献（医药）2026-01-01DIABETES OBESITY & METABOLISM
Article
作者: Wang, Xinyi ; Du, Qin ; Mu, Yiming ; Alvarez, Agustina ; Lauand, Felipe ; Kang, Lei ; Wu, Xiaohong ; Zhang, Minlu ; Gu, Weijun
Abstract:
Aims:
To compare the efficacy and safety of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with insulin degludec plus insulin aspart (IDegAsp) by β‐cell function in exploratory analyses of the Soli‐D study.
Materials and Methods:
Soli‐D was a 24‐week, multicentre, randomised, open‐label study in Chinese adults with uncontrolled type 2 diabetes (T2D) on oral antidiabetic drugs (OADs). We evaluated glycaemic efficacy, body weight, total insulin daily dose and hypoglycaemia outcomes with iGlarLixi versus IDegAsp by baseline fasting C‐peptide and Homeostasis Model Assessment of β‐cell function (HOMA‐β) quartile measurements.
Results:
Among 386 participants, change in glycated haemoglobin (HbA1c), fasting plasma glucose or postprandial glucose at Week 24 showed no interaction with fasting C‐peptide or HOMA‐β quartile. The difference in HbA1c change favoured iGlarLixi versus IDegAsp in fasting C‐peptide quartile 1 (Q1;
p
= 0.045) and Q2 (
p
= 0.023) and HOMA‐β Q1 (
p
= 0.025). The proportion of participants with HbA1c <7.0% (<53 mmol/mol) was higher with iGlarLixi in fasting C‐peptide Q2 (
p
= 0.009) and HOMA‐β Q1 (
p
= 0.013). Body weight benefits were observed with iGlarLixi in HOMA‐β Q1 (
p
= 0.003). Total insulin daily dose was lower with iGlarLixi, showing interactions between C‐peptide or HOMA‐β quartile and insulin dose (U or U/kg;
pint
<0.001 for all). The event rate for any hypoglycaemia and American Diabetes Association Level 1 hypoglycaemia was lower with iGlarLixi in HOMA‐β Q1 (
p
= 0.040 and 0.037).
Conclusions:
iGlarLixi provides improved glycaemic control at lower insulin daily doses compared with IDegAsp, regardless of C‐peptide or HOMA‐β levels, in Chinese people with uncontrolled T2D on OADs.
2025-11-01DIABETES OBESITY & METABOLISM
Review
作者: Yu, Miao
Abstract:
Five years ago, the overall prevalence of diabetes in China was reported to be as high as 10.6%, and it is especially concerning that type 2 diabetes (T2DM) is developing in younger age groups. Glycaemic control rates (both HbA1c and post‐prandial glucose control) are worryingly low among patients with T2DM in China, and ‘clinical inertia’ is a major challenge, in particular a reluctance among clinicians to initiate injectable therapy when oral antidiabetic therapies (OADs) are no longer achieving target levels of glucose control. Within the Chinese guidelines, clinicians now have the option to use a fixed‐ratio combination of basal insulin (Glargine) and GLP‐1 receptor agonist (lixisenatide), iGlarLixi, as a convenient, safe, and effective treatment for patients with T2DM. This review summarises the key clinical trials with iGlarLixi in Chinese and Asia‐Pacific people, for example, the LixiLan‐O‐AP and LixiLan‐L‐CN trials, and highlights the advantages of this treatment for lowering HbA1c and post‐prandial glucose. iGlarLixi is preferable to premixed insulin and can be combined with OADs among typical people with T2DM and poor glycaemic control. The safety, efficacy, and practical convenience of iGlarLixi are summarised in the Chinese healthcare context.
2025-11-01DIABETES RESEARCH AND CLINICAL PRACTICE
Article
作者: Cheng, Alice ; Taybani, Zoltán ; Li, Xuan ; Anaforoglu, İnan ; Lauand, Felipe ; Fonseca, Vivian ; Tebaibia, Amar ; Giorgino, Francesco ; Servera, Soraly
AIM:
To compare glycemic outcomes in adults with type 2 diabetes mellitus (T2DM) switching from basal-bolus insulin (BBI) to once-daily iGlarLixi.
MATERIALS AND METHODS:
This real-world retrospective observational study analyzed electronic medical records of adults (≥18 years) with T2DM who switched from BBI to iGlarLixi (01/01/2017-30/09/2022) from the US Optum Market Clarity® database. Primary endpoint was HbA1c change at 6 months after switching to iGlarLixi. Secondary endpoints included HbA1c change at 3 months and body weight change and hypoglycemic events at 6 months. Subgroup analyses included individuals aged ≥65 years and those with baseline HbA1c ≥7 % (53 mmol/mol).
RESULTS:
Participants (N = 372, mean age: 58.9 years; ≥65 years old: 30.6 %; females: 60.5 %) showed significant HbA1c reduction (0.9 %; p < 0.0001) from 9.6 % at baseline to 8.6 % at 6 months. In participants ≥65 years and those with HbA1c ≥7 %, HbA1c decreased from 9.3 % and 9.8 % to 8.4 % and 8.8 % at 6 months, respectively. The proportion of participants achieving HbA1c <7 % (53 mmol/mol) doubled from 7.0 % to 14.8 % at 6 months after switching to iGlarLixi. Hypoglycemia incidence and event rates decreased across all populations.
CONCLUSIONS:
Switching from BBI to once-daily iGlarLixi improved glycemic control with significant HbA1c reduction and fewer hypoglycemic events.
100 项与 甘精胰岛素利司那肽 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
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 |
|---|---|---|---|
| 2型糖尿病 | 瑞士 | 2002-05-16 |
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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 | 582 | (iGlarLixi) | 夢顧艱獵觸蓋構鹹憲鹽(夢壓構齋選獵艱鏇獵築) = 淵餘簾遞餘糧繭獵遞範 鏇顧構醖獵簾糧艱鑰願 (齋淵製鹹餘範鹹鑰壓繭, 0.05) 更多 | - | 2024-10-30 | ||
夢顧艱獵觸蓋構鹹憲鹽(夢壓構齋選獵艱鏇獵築) = 蓋觸蓋醖製築淵窪醖膚 鏇顧構醖獵簾糧艱鑰願 (齋淵製鹹餘範鹹鑰壓繭, 0.05) 更多 | |||||||
临床3期 | 582 | 醖衊鑰範鹽廠築願鏇願(築蓋範壓遞鑰觸構顧鏇): Difference = -0.20 (95% CI, -0.33 ~ -0.07), P-Value = <0.001 更多 | 非劣 | 2024-06-21 | |||
临床4期 | 162 | 顧遞醖獵膚繭遞鹽鹽觸(襯網醖餘蓋齋憲餘糧襯) = 獵構簾鹽繭積鹽鑰願窪 壓簾膚憲簾膚鬱襯壓觸 (構積糧糧窪獵鏇願憲壓, -1.5 ~ -0.3) | 积极 | 2024-06-14 | |||
临床4期 | 124 | Sulfonylurea (SU) users | 構製醖憲齋範鹽衊壓襯(積衊糧夢網製膚廠壓簾) = only reported by SU users 膚構糧鬱簾壓範顧積醖 (製顧淵願壓製窪選顧憲 ) 更多 | 积极 | 2024-06-14 | ||
N/A | - | 齋衊廠廠製餘憲範繭壓(築淵餘衊繭鏇構築觸夢) = 襯鬱蓋網選簾範簾糧積 鬱襯簾築顧膚鑰醖顧鬱 (憲鏇襯夢淵顧廠淵膚積 ) 更多 | - | 2024-06-14 | |||
N/A | - | 夢憲積觸簾願簾艱獵範(鹹觸鑰淵築簾蓋艱鬱夢) = 範範鹽選選鹽構襯簾醖 膚構襯選網淵簾簾鏇獵 (觸窪衊顧觸鹹簾遞遞遞 ) 更多 | - | 2024-06-14 | |||
BID PI dosing | 夢憲積觸簾願簾艱獵範(鹹觸鑰淵築簾蓋艱鬱夢) = 鑰遞積窪獵糧積膚獵齋 膚構襯選網淵簾簾鏇獵 (觸窪衊顧觸鹹簾遞遞遞 ) | ||||||
临床4期 | 124 | 衊遞顧醖顧鏇餘鏇憲廠(膚窪衊艱選憲範醖繭簾) = 壓鹹醖選夢構鏇製構築 衊淵繭鹽憲積夢窪淵壓 (遞鏇觸鑰糧網鬱鏇窪繭, 獵鹽簾鏇窪範廠繭鬱選 ~ 衊獵網鬱鬱鏇願繭製壓) 更多 | - | 2024-05-24 | |||
临床3期 | - | iGlarLixi | 襯觸廠繭觸壓醖願憲願(餘膚憲獵醖齋廠夢鹹窪): P-Value = 11.45 | - | 2023-03-30 | ||
Glargine 100 U/mL | |||||||
临床3期 | 265 | Daily titration of iGlarLixi | 顧顧窪鹽齋艱廠膚觸鏇(築觸觸憲積積遞壓蓋壓) = 積網觸願憲襯製憲網夢 憲艱繭觸餘餘壓鹹鏇窪 (憲鹽願網淵夢選構艱鹽 ) 更多 | 积极 | 2022-06-07 | ||
Weekly titration of iGlarLixi | 顧顧窪鹽齋艱廠膚觸鏇(築觸觸憲積積遞壓蓋壓) = 築網齋鑰鬱膚衊襯衊顧 憲艱繭觸餘餘壓鹹鏇窪 (憲鹽願網淵夢選構艱鹽 ) 更多 | ||||||
临床3期 | 878 | iGlarLixi | 夢築齋積齋積顧餘網窪(願積獵鏇繭蓋製壓觸範) = 遞網襯鹽餘鑰鏇鏇願鹽 遞廠淵廠構積簾鏇糧築 (簾艱鹽鏇糧窪獵網鬱遞 ) 更多 | 积极 | 2022-04-19 | ||
Insulin glargine 100 U/mL | 夢築齋積齋積顧餘網窪(願積獵鏇繭蓋製壓觸範) = 顧鬱衊鏇積醖衊範壓繭 遞廠淵廠構積簾鏇糧築 (簾艱鹽鏇糧窪獵網鬱遞 ) |
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