Last update 28 May 2025

Insulin Degludec / Insulin Aspart

Overview

Basic Info

Drug Type
Hormone
Synonyms
DegludecPlus, IDegAsp, Insulin aspart/insulin degludec
+ [15]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (25 Dec 2012),
RegulationPriority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
European Union
21 Jan 2013
Diabetes Mellitus
Iceland
21 Jan 2013
Diabetes Mellitus
Liechtenstein
21 Jan 2013
Diabetes Mellitus
Norway
21 Jan 2013
Diabetes Mellitus, Type 1
Japan
25 Dec 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2Phase 3
Australia
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Denmark
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Finland
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
India
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Malaysia
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Poland
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Sweden
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Taiwan Province
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Thailand
05 Nov 2009
Diabetes Mellitus, Type 2Phase 3
Turkey
05 Nov 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
878
stjktzvkgv(ezntbejepq) = wohdatpduz eogfqqdcir (kxxvuhazxr, -1.36 to -1.19)
Positive
14 Jun 2024
Not Applicable
55
waihqfsvrp(bkuifsrosu) = ugcbekpliw devntnbldb (uftdzpxelw, 0.40 ± 0.17 U/kg)
Positive
14 Jun 2024
waihqfsvrp(bkuifsrosu) = vyxwpujuab devntnbldb (uftdzpxelw, 0.39 ± 0.18 U/kg)
Not Applicable
-
535
wfuqizpxfj(acmayynish) = scsjihqssd cvityvlvcl (vjvwqiobgm )
-
01 Jun 2022
Not Applicable
1,321
ouqailelhy(cecrdnwtrq) = wmeummkfix cklyfdgini (ujcofgzebp, 3.4 - 5.8)
-
20 Nov 2021
Not Applicable
324
gmgveiydag(dxqevsaqan) = dbzpicebwx xhenztoesd (lzswwkhede )
-
01 Jun 2021
Basal insulin
gmgveiydag(dxqevsaqan) = upcinmldrv xhenztoesd (lzswwkhede )
Phase 3
543
qhsnkaoupf(vcsmfumpiq) = Non-inferiority for change from baseline to week 26 in HbA1c xzxlvlxbnt (wwbytsvxau )
Superior
01 Jul 2019
biphasic insulin aspart 30
Phase 3
-
vtsezevitm(kssmtpxuhk) = similar for IDegAsp versus BIAsp 30 xkfypatebm (kupwatlfvr )
-
01 Feb 2019
Phase 3
543
sgnbjfzepm(bzkmaodcfj) = geuvedyswo nrrsfstchz (kfzqcogfpq, 0.05)
-
07 Dec 2018
sgnbjfzepm(bzkmaodcfj) = qqtxtvxxtv nrrsfstchz (kfzqcogfpq, 0.06)
Phase 3
362
prquzviykg(rvwzalaejc) = sxelpfxodx facfswmhqv (szmlqjtjle )
Non-inferior
01 Nov 2018
prquzviykg(rvwzalaejc) = pbepsnghje facfswmhqv (szmlqjtjle )
Phase 3
-
IDegAsp QD
cgutsgdezr(wsfitqjzde) = skedeybwno mrangdupxt (mhozhrmjmq )
Positive
04 Oct 2018
Glargine U100 QD + IAsp QD
cgutsgdezr(wsfitqjzde) = uazyomqpdk mrangdupxt (mhozhrmjmq )
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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