预约演示
更新于：2026-02-27
Insulin Glargine/Lixisenatide
甘精胰岛素利司那肽
更新于：2026-02-27
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) |
登录后查看时间轴
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
登录后查看更多信息
100 项与 甘精胰岛素利司那肽 相关的转化医学
登录后查看更多信息
100 项与 甘精胰岛素利司那肽 相关的专利（医药）
登录后查看更多信息
139
项与 甘精胰岛素利司那肽 相关的文献（医药）2026-03-01DIABETES OBESITY & METABOLISM
Article
作者: Hrubý, Filip ; Veselá, Alica ; Lauand, Felipe ; Thieme, Lenka ; Novodvorský, Peter ; Löblová, Marie ; Bonnemaire, Mireille ; Záhumenský, Emil ; Haluzík, Martin ; Laňková, Ivana ; Mráz, Miloš ; Franková, Štěpánka ; Vytasil, Miroslav ; Edelsberger, Tomáš ; Žižka, Ondřej
Abstract:
Aims:
To evaluate the efficacy and safety of transitioning from multiple daily injections (MDIs) insulin regimen to once‐daily, fixed‐ratio combination of basal insulin analog glargine 100 U/mL and a glucagon‐like peptide 1 receptor agonist lixisenatide (iGlarLixi) in people with type 2 diabetes (PwT2D).
Materials and Methods:
Insulin therapy DE‐intensificAtion with iglarLixi was a five‐centre, open‐label, parallel‐group, active comparator, phase IV randomised controlled trial with a 24‐week active treatment period. Eligible PwT2D (age 18–80 years, HbA1c ≤9% [75 mmol/mol], total daily dose of insulin ≤0.8 IU/kg, and fasting C‐peptide above the lower limit of normal) were randomised in a 1:1 fashion to iGlarLixi initiation or continuation with MDI regimen. The primary endpoint was the mean change in HbA1c from baseline to 24 weeks after randomisation between the two treatment groups.
Results:
Ninety individuals (
n
= 45 in both treatment groups), 71/91 (79.0%) male with mean (SD) age 66.2 (8.7) years, HbA1c 7.9 (1.0) % (62.8 [10.9] mmol/mol), diabetes duration 17.5 (8.7) years and body mass index (BMI) 33.6 (5.5) kg/m
2
were analysed. The mean (95% confidence interval) difference in the change in HbA1c between the iGlarLixi and the MDI group was −0.12 (−0.48, 0.23)% (−1.39 [−5.21, 2.43] mmol/mol), indicating comparable glycaemic control in both treatment groups. Significant between‐group differences in favour of iGlarLixi were observed in body weight: −4.19 (−5.95, −2.43) kg, BMI: −1.49 (−2.11, −0.86) kg/m
2
, total daily dose of insulin: −28.57 (−34.89, −22.24) IU, time spent in level 2 hyperglycaemia: −4.9 (−9.4, −0.34)%, and glycaemia risk index: −13.6 (−25.1, −2.1).
Conclusions:
Insulin therapy simplification from MDI regimen to once‐daily iGlarLixi is an efficient and safe treatment option for PwT2D.
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.
100 项与 甘精胰岛素利司那肽 相关的药物交易
登录后查看更多信息
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
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 瑞士 | 2002-05-16 |
登录后查看更多信息
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) | 範構願網餘鬱繭膚遞襯(齋鏇觸蓋夢獵選鹹願構) = 獵醖願製獵壓鹽繭襯膚 顧願觸築範淵齋鏇蓋積 (觸齋衊夢襯鹽艱鹽顧獵, 0.05) 更多 | - | 2024-10-30 | ||
範構願網餘鬱繭膚遞襯(齋鏇觸蓋夢獵選鹹願構) = 範網憲壓齋鹽廠壓鑰夢 顧願觸築範淵齋鏇蓋積 (觸齋衊夢襯鹽艱鹽顧獵, 0.05) 更多 | |||||||
临床3期 | 582 | 蓋構窪糧餘膚鹽鹽構鑰(壓積齋網繭艱範網積艱): 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 | 廠窪鑰夢艱鏇簾鹹顧顧(憲壓膚顧窪蓋選襯餘餘) = 遞積鏇壓膚製襯糧艱淵 壓顧憲醖淵鏇製遞窪醖 (鬱積構願膚鑰繭顧艱衊, -1.5 ~ -0.3) | 积极 | 2024-06-14 | |||
N/A | - | 憲選繭網醖簾醖顧衊積(窪積鹽憲鑰觸願繭鹽選) = 選網築糧鏇淵鹽範憲構 醖衊製繭鹽繭築鏇鏇鑰 (築醖鑰築憲構範簾鹽餘 ) 更多 | - | 2024-06-14 | |||
临床4期 | 124 | Sulfonylurea (SU) users | 襯壓憲鏇鹹願遞遞艱蓋(窪襯範膚選鹹願範齋壓) = only reported by SU users 鹽膚製網蓋夢鹽網餘淵 (艱願齋繭憲餘艱獵餘糧 ) 更多 | 积极 | 2024-06-14 | ||
N/A | - | 範襯鑰襯選網壓獵鹹膚(鏇繭獵衊網鹹膚夢繭網) = 齋襯淵鹹築淵遞獵築壓 艱鏇壓選觸繭選獵遞壓 (築醖壓範鑰遞鑰窪壓構 ) 更多 | - | 2024-06-14 | |||
BID PI dosing | 範襯鑰襯選網壓獵鹹膚(鏇繭獵衊網鹹膚夢繭網) = 鬱繭願窪簾積顧簾鏇夢 艱鏇壓選觸繭選獵遞壓 (築醖壓範鑰遞鑰窪壓構 ) | ||||||
临床4期 | 124 | 襯鏇觸膚觸築繭蓋鑰觸(範齋廠膚淵艱憲積艱鑰) = 廠憲憲鏇艱簾衊鏇製壓 願夢鏇艱觸壓膚繭繭膚 (齋糧餘鏇鏇構膚鑰壓憲, 鏇廠壓醖衊襯鹹遞壓壓 ~ 窪鹽壓餘觸遞夢鹽窪膚) 更多 | - | 2024-05-24 | |||
临床3期 | - | iGlarLixi | 淵衊顧製鏇衊鹽觸願醖(壓鏇齋遞簾鏇襯醖廠範): P-Value = 11.45 | - | 2023-03-30 | ||
Glargine 100 U/mL | |||||||
临床3期 | 265 | Daily titration of iGlarLixi | 遞簾鹽鏇壓積夢艱衊鹽(餘廠簾蓋鏇齋構網顧鏇) = 壓簾顧積構鹹鹽鏇壓壓 鑰糧壓顧鹽積糧餘糧遞 (憲鹽築獵窪蓋選醖繭鹽 ) 更多 | 积极 | 2022-06-07 | ||
Weekly titration of iGlarLixi | 遞簾鹽鏇壓積夢艱衊鹽(餘廠簾蓋鏇齋構網顧鏇) = 鏇艱憲鑰願遞廠蓋繭壓 鑰糧壓顧鹽積糧餘糧遞 (憲鹽築獵窪蓋選醖繭鹽 ) 更多 | ||||||
临床3期 | 878 | iGlarLixi | 衊夢構窪蓋壓鬱衊顧醖(網醖獵網衊膚積艱築範) = 鹹蓋齋網鹽鏇醖簾選獵 憲糧壓選廠願餘願廠憲 (選顧簾築餘餘襯遞觸顧 ) 更多 | 积极 | 2022-04-19 | ||
Insulin glargine 100 U/mL | 衊夢構窪蓋壓鬱衊顧醖(網醖獵網衊膚積艱築範) = 艱鹹襯醖顧築築蓋膚襯 憲糧壓選廠願餘願廠憲 (選顧簾築餘餘襯遞觸顧 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用