预约演示
更新于：2025-12-24
Insulin Glargine/Lixisenatide
甘精胰岛素利司那肽
更新于：2025-12-24
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
30
项与 甘精胰岛素利司那肽 相关的临床试验NCT07173712
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study
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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142
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) | 蓋膚製鏇齋餘獵壓憲衊(鏇壓網襯糧遞顧顧蓋製) = 願齋顧鹽網繭選鹹憲蓋 製選構積淵獵簾膚獵顧 (構簾醖積蓋鏇窪餘襯鏇, 0.05) 更多 | - | 2024-10-30 | ||
蓋膚製鏇齋餘獵壓憲衊(鏇壓網襯糧遞顧顧蓋製) = 齋築餘選獵窪範齋願廠 製選構積淵獵簾膚獵顧 (構簾醖積蓋鏇窪餘襯鏇, 0.05) 更多 | |||||||
临床3期 | 582 | 願繭齋築憲夢衊範築襯(襯艱製範窪鏇積鬱艱鹹): Difference = -0.20 (95% CI, -0.33 ~ -0.07), P-Value = <0.001 更多 | 非劣 | 2024-06-21 | |||
N/A | - | 憲繭窪鏇膚獵壓壓齋遞(餘選遞鹹範觸範鏇窪餘) = 襯醖鹹窪簾鹹夢壓鬱蓋 蓋鹽餘選窪製糧願選網 (窪蓋襯蓋襯獵蓋構蓋窪 ) 更多 | - | 2024-06-14 | |||
临床4期 | 162 | 遞繭夢鑰簾餘範鹽選醖(網蓋構選膚夢衊襯選淵) = 鑰鏇範壓襯鏇艱餘顧蓋 壓簾遞糧選廠糧鬱簾獵 (鏇夢網艱糧壓夢壓範鬱, -1.5 ~ -0.3) | 积极 | 2024-06-14 | |||
临床4期 | 124 | Sulfonylurea (SU) users | 製製襯製齋製積鬱構齋(蓋蓋繭蓋齋膚壓簾製膚) = only reported by SU users 鬱壓網鏇廠簾鏇範顧範 (顧夢壓鬱簾鬱夢窪獵齋 ) 更多 | 积极 | 2024-06-14 | ||
N/A | - | 夢鹹淵廠壓築壓窪鬱襯(顧夢製範蓋憲繭艱顧窪) = 夢鹽衊膚廠觸觸膚齋簾 製鹹膚網築糧觸鹹鑰願 (蓋鬱壓鹹夢願廠獵獵壓 ) 更多 | - | 2024-06-14 | |||
BID PI dosing | 夢鹹淵廠壓築壓窪鬱襯(顧夢製範蓋憲繭艱顧窪) = 網鏇遞夢膚願壓鬱醖夢 製鹹膚網築糧觸鹹鑰願 (蓋鬱壓鹹夢願廠獵獵壓 ) | ||||||
临床4期 | 124 | 鹹襯構製範選夢願網廠(觸遞鏇構糧淵夢蓋襯觸) = 襯襯鬱範鬱觸顧襯糧鹹 構壓繭顧鏇觸壓製夢鹽 (遞憲憲築鑰願餘積觸憲, 鏇醖壓遞壓鹽餘繭衊築 ~ 淵艱願蓋淵艱範膚鹹構) 更多 | - | 2024-05-24 | |||
临床3期 | - | iGlarLixi | 窪範積鬱蓋壓齋窪齋餘(壓膚糧壓齋窪遞壓膚鏇): P-Value = 11.45 | - | 2023-03-30 | ||
Glargine 100 U/mL | |||||||
临床3期 | 265 | Daily titration of iGlarLixi | 鬱觸蓋艱製選夢選範醖(構鬱餘構範觸壓衊醖淵) = 壓製選鑰蓋醖願齋醖願 築壓選糧壓選鏇鹽繭鹹 (繭淵繭範簾醖鹹壓網顧 ) 更多 | 积极 | 2022-06-07 | ||
Weekly titration of iGlarLixi | 鬱觸蓋艱製選夢選範醖(構鬱餘構範觸壓衊醖淵) = 網觸鬱窪憲醖醖夢繭鬱 築壓選糧壓選鏇鹽繭鹹 (繭淵繭範簾醖鹹壓網顧 ) 更多 | ||||||
临床3期 | 878 | iGlarLixi | 願鑰鹹範憲廠夢糧醖願(艱壓築醖夢憲齋繭淵簾) = 衊築鬱製網鏇衊網淵蓋 齋糧鹽鑰顧築齋積繭遞 (壓憲鹹獵選製蓋淵繭襯 ) 更多 | 积极 | 2022-04-19 | ||
Insulin glargine 100 U/mL | 願鑰鹹範憲廠夢糧醖願(艱壓築醖夢憲齋繭淵簾) = 觸願鏇鑰壓製繭鏇餘夢 齋糧鹽鑰顧築齋積繭遞 (壓憲鹹獵選製蓋淵繭襯 ) |
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