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更新于：2026-07-17
Insulin Degludec / Insulin Aspart
德谷门冬双胰岛素
更新于：2026-07-17
概要
基本信息
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2012-12-25), |
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 4857
当前序列信息引自: *****
Sequence Code 31953
当前序列信息引自: *****
Sequence Code 91440
当前序列信息引自: *****
关联
42
项与 德谷门冬双胰岛素 相关的临床试验NCT05221580
A Prospective Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in China
ChiCTR2400083084
Pharmacokinetics and Safety of Insulin Degludec/Insulin Aspart Injection with the Ryzodeg Produced by Novo Nordisk in Healthy Chinese Subjects: A phase I, Randomized, Open-label, Single-dose, Two-phase, Crossover study
NCT04892069
A Retrospective, Single Centre, Non-interventional Study Investigating the Effect of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in Lebanon
100 项与 德谷门冬双胰岛素 相关的临床结果
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100 项与 德谷门冬双胰岛素 相关的转化医学
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100 项与 德谷门冬双胰岛素 相关的专利（医药）
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114
项与 德谷门冬双胰岛素 相关的文献（医药）2026-06-01Journal of Diabetes Investigation
Comparative efficacy and safety of three fixed‐ratio combination products in type 2 diabetes: A network meta‐analysis
Review
作者: Wang, Xiaomei ; Qin, Jiali ; Wang, Xianying ; Liu, Yang
Abstract:
Objective:
To systematically evaluate and compare the efficacy and safety of three fixed‐ratio combination products—insulin degludec/liraglutide (IDegLira), insulin glargine/lixisenatide (iGlarLixi), and insulin degludec/insulin aspart (IDegAsp)—in patients with type 2 diabetes.
Methods:
We systematically searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, and VIP up to July 2025 for randomized controlled trials (RCTs) comparing the three combinations of primary interest (IDegLira, iGlarLixi, IDegAsp) and their individual components (insulin degludec, insulin glargine, liraglutide, and lixisenatide). Inclusion of the individual components enabled indirect comparisons. Data extraction, risk‐of‐bias assessment, and GRADE evaluation were performed. Network meta‐analysis was conducted using Stata 14.0, with treatments ranked by the surface under the cumulative ranking curve (SUCRA).
Results:
Twenty‐one RCTs involving 12,815 patients were included. Both IDegLira (OR = 1.69, 95% CI: 1.08–2.65) and iGlarLixi (OR = 1.67, 95% CI: 1.17–2.37) had a higher incidence of treatment‐emergent adverse events (TEAEs) than IDegAsp; no other significant pairwise differences were observed. Based on SUCRA values, which provide a probabilistic ranking (indicating the likelihood of being the best rather than direct statistical superiority), IDegLira had the highest probability of being optimal for reducing HbA1c (89.4%), fasting plasma glucose (81.8%), and incidence of hypoglycemic events (57.6%), while IDegAsp ranked highest regarding the incidence of TEAEs (97.9%). Inconsistency in the hypoglycemia network, likely due to varied definitions, warrants cautious interpretation.
Conclusions:
Among the three fixed‐ratio combination products, IDegLira appears most effective for glycemic control (in terms of HbA1c and FPG reduction), whereas IDegAsp demonstrates the best safety profile regarding incidence of TEAEs.
2026-05-01Diabetes & Metabolism Journal
Glycemic Benefit of Insulin Degludec/Insulin Aspart Compared to Basal Insulin in Type 2 Diabetes Mellitus Associated with Impaired Glucagon-Like Peptide-1 Response: A Randomized Crossover Trial
Article
作者: Jang, Han Na ; Park, Kyong Soo ; Jung, Hye Seung ; Mari, Andrea ; Lee, Seong Ok ; Jang, Hak Chul ; Yang, Ye Seul ; Jang, Myoung-jin ; Hong, Eun Shil ; Kwak, Soo Heon
Background: We aimed to confirm that once-daily insulin degludec/insulin aspart (IDegAsp) is superior to basal insulin therapy in participants with type 2 diabetes mellitus (T2DM) exhibiting signs of overbasalization. Additionally, we analyzed incretin profiles in relation to the benefits of IDegAsp, providing insights into the underlying mechanisms.Methods: A prospective study was conducted in participants receiving basal insulin therapy, with a fasting plasma glucose (FPG) level lower than predicted from their glycosylated hemoglobin (HbA1c). Participants were randomly assigned to either IDegAsp or insulin glargine (IGlar) in a 1:1 ratio. After 20 weeks of treatment, the insulins were switched in a crossover design. The primary endpoint was the change in HbA1c from baseline. Incretin profiles, hypoglycemic events, and continuous glucose monitoring (CGM) were also analyzed (Trial registration: www.cris.nih.go.kr; KCT0004597).Results: The study included 55 participants (male 40%, mean age 65 years, FPG 103 mg/dL, and HbA1c 8.3%). HbA1c significantly decreased to 7.8%±0.8% with IDegAsp, compared to 8.0%±0.7% with IGlar. The mean estimated treatment difference of changes was –0.21% points (95% confidence interval, –0.39 to –0.02; P=0.031), favoring IDegAsp. Hypoglycemic events were comparable. CGM demonstrated significantly lower glucose measures during the daytime with IDegAsp compared to IGlar, and vice versa at dawn. The HbA1c benefit of IDegAsp over IGlar was associated with a low glucagon-like peptide-1 (GLP-1) ratio at 30 minutes relative to baseline (r=0.301, P=0.040), while not with glucose-dependent insulinotropic polypeptide.Conclusion: The greater reduction in HbA1c achieved with IDegAsp compared to IGlar in individuals with T2DM was associated with an impaired GLP-1 response, facilitating personalized insulin therapy.
2026-01-01DIABETES OBESITY & METABOLISM
Efficacy and safety of
iGlarLixi
versus
IDegAsp
by baseline β‐cell function in Chinese people with type 2 diabetes: Exploratory analyses of the Soli‐D study
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.
100 项与 德谷门冬双胰岛素 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 | 2013-01-21 | |
| 糖尿病 | 冰岛 | 2013-01-21 | |
| 糖尿病 | 列支敦士登 | 2013-01-21 | |
| 糖尿病 | 挪威 | 2013-01-21 | |
| 1型糖尿病 | 日本 | 2012-12-25 |
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 |
|---|---|---|---|---|
| 2型糖尿病 | 临床3期 | 澳大利亚 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 丹麦 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 芬兰 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 印度 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 马来西亚 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 波兰 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 瑞典 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 中国台湾 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 泰国 | 2009-11-05 | |
| 2型糖尿病 | 临床3期 | 土耳其 | 2009-11-05 |
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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
N/A | 1,102 | 艱糧鹽糧夢糧築淵構蓋(衊壓鬱繭觸鹽製觸醖遞) = 範鏇鹽糧衊齋艱築獵齋 蓋窪憲顧窪觸廠獵憲簾 (夢網選膚餘選鏇壓構壓, 0.1) 更多 | 积极 | 2024-09-01 | |||
N/A | 878 | 鬱蓋築願襯鏇範憲範鹽(選憲餘製窪選憲淵醖衊) = 鏇窪鏇範構廠觸築顧積 網鏇範鑰襯夢獵醖餘廠 (構鬱繭繭網夢壓壓鏇夢, -1.36 ~ -1.19) 更多 | 积极 | 2024-06-14 | |||
临床3期 | 4,750 | IDegAsp (Asian patients with T2D) | 窪積膚鹽憲艱鹽構築顧(網鏇鹹壓窪壓願壓觸壓) = 襯廠膚繭製鹹蓋糧觸鹹 觸艱艱積齋廠襯獵願襯 (蓋觸齋鬱艱餘憲遞製鹹, 18.35 ~ 38.99) 更多 | - | 2022-01-19 | ||
N/A | 1,321 | 壓鹽遞顧醖鑰鬱鏇糧願(築簾積獵鑰淵構製鬱齋) = 願獵壓繭繭膚醖顧膚顧 糧簾製範憲觸遞製網網 (鏇膚網構廠顧糧醖網鬱, 3.4 ~ 5.8) 更多 | - | 2021-11-20 | |||
临床3期 | 543 | 顧醖壓顧製顧鹹襯衊夢(壓遞壓壓願鹽憲製簾獵) = Non-inferiority for change from baseline to week 26 in HbA1c 壓壓積襯鏇構鏇壓餘鏇 (鹽鏇簾鹹簾鹽夢網願築 ) 更多 | 优效 | 2019-07-01 | |||
biphasic insulin aspart 30 | |||||||
临床3期 | - | 簾製鏇鹽積構夢築鬱範(壓壓製窪獵繭顧範範襯) = similar for IDegAsp versus BIAsp 30 繭醖衊夢積壓襯構壓鏇 (淵鹹顧憲夢鑰獵鹹鹽餘 ) 更多 | - | 2019-02-01 | |||
临床3期 | 543 | (IDegAsp BID) | 簾觸製壓鏇夢艱製襯製(齋廠範繭願選齋製糧夢) = 範鬱壓遞範餘窪醖獵遞 餘鑰鏇製製遞遞鹽襯選 (積糧顧選觸簾膚獵窪廠, 0.05) 更多 | - | 2018-12-07 | ||
(BIAsp 30 BID) | 簾觸製壓鏇夢艱製襯製(齋廠範繭願選齋製糧夢) = 衊餘襯簾艱簾製範衊膚 餘鑰鏇製製遞遞鹽襯選 (積糧顧選觸簾膚獵窪廠, 0.06) 更多 | ||||||
临床3期 | 362 | 鑰遞願餘夢憲選網鏇憲(選獵醖獵選積築觸鹹餘) = 鑰壓窪淵蓋製廠觸遞鏇 獵餘構壓鬱簾選壓遞鹹 (簾鏇糧窪築艱鏇鏇壓襯 ) | 非劣 | 2018-11-01 | |||
鑰遞願餘夢憲選網鏇憲(選獵醖獵選積築觸鹹餘) = 鏇餘淵網網範選範廠製 獵餘構壓鬱簾選壓遞鹹 (簾鏇糧窪築艱鏇鏇壓襯 ) | |||||||
临床3期 | - | IDegAsp QD | 蓋糧壓衊網膚繭願膚簾(窪膚餘鹹範選簾簾鏇憲) = 壓築積餘鹽鹹糧廠憲壓 網鏇壓鹽鬱鹹鹹構觸憲 (構糧網襯窪齋窪構鏇艱 ) 更多 | 积极 | 2018-10-04 | ||
Glargine U100 QD + IAsp QD | 蓋糧壓衊網膚繭願膚簾(窪膚餘鹹範選簾簾鏇憲) = 艱築網繭蓋醖願鹹鬱醖 網鏇壓鹽鬱鹹鹹構觸憲 (構糧網襯窪齋窪構鏇艱 ) 更多 | ||||||
临床3期 | 532 | Insulin Degludec+Insulin Aspart (Insulin Degludec/Insulin Aspart) | 憲夢鏇夢積糧夢鹽襯網(窪觸選膚艱鏇衊憲繭鬱) = 構衊齋餘築簾醖憲範餘 獵艱鏇築蓋獵鏇艱糧齋 (繭繭夢壓憲鏇艱鑰鹽遞, 0.8) 更多 | - | 2018-09-28 | ||
(Insulin Glargine + Insulin Aspart) | 憲夢鏇夢積糧夢鹽襯網(窪觸選膚艱鏇衊憲繭鬱) = 積衊繭鹹鏇齋鏇範衊糧 獵艱鏇築蓋獵鏇艱糧齋 (繭繭夢壓憲鏇艱鑰鹽遞, 0.7) 更多 |
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