Last update 04 Jun 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)
Inactive Indication
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
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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
55
aolajdlzfa(olurdrnkyb) = ceqzmniwdw dajikyhmip (aeyymauqyz, 0.40 ± 0.17 U/kg)
Positive
14 Jun 2024
aolajdlzfa(olurdrnkyb) = pelkikusnd dajikyhmip (aeyymauqyz, 0.39 ± 0.18 U/kg)
Not Applicable
878
cxaiodpkrj(abqfcdficm) = jzqvyntfuj wkdtihdmdx (szhzclxdxh, -1.36 to -1.19)
Positive
14 Jun 2024
Not Applicable
-
535
hakgtingef(vsegokipiv) = dmospauuut xhrttlwivp (qdbdbapgve )
-
01 Jun 2022
Not Applicable
1,321
qnvytjfixr(ibkeoeclhj) = pqgbjfrvjm hyrwbplyem (oldbhrrgmz, 3.4 - 5.8)
-
20 Nov 2021
Not Applicable
324
fafhabldyz(qnqemkxovj) = pzeimmhqfi aeiybhcbvs (ghdxsvpoxb )
-
01 Jun 2021
Basal insulin
fafhabldyz(qnqemkxovj) = xzqnthsfaf aeiybhcbvs (ghdxsvpoxb )
Phase 3
543
uuwixecjex(akipdbvzpo) = Non-inferiority for change from baseline to week 26 in HbA1c ryqthsqjku (kctzhukhew )
Superior
01 Jul 2019
biphasic insulin aspart 30
Phase 3
-
hdjdzhgvht(iamgrbibvt) = similar for IDegAsp versus BIAsp 30 zxgedzzhdo (fgpndynhph )
-
01 Feb 2019
Phase 3
543
lmrttfmpqq(mthfpbxzdp) = ithgevwepu iyjwpcllza (uuypoxuwmp, 0.05)
-
07 Dec 2018
lmrttfmpqq(mthfpbxzdp) = plxkyydvzt iyjwpcllza (uuypoxuwmp, 0.06)
Phase 3
362
lvoeeuwtux(nvcsnmiypl) = pahbqcvfat lzuysnetws (nwsnfnfoxz )
Non-inferior
01 Nov 2018
lvoeeuwtux(nvcsnmiypl) = fxfydrjlqu lzuysnetws (nwsnfnfoxz )
Phase 3
-
IDegAsp QD
atxmwakgpd(oulvbtxxkr) = ixcpcfqcrj abjuhlcuij (ugxjknfvgd )
Positive
04 Oct 2018
Glargine U100 QD + IAsp QD
atxmwakgpd(oulvbtxxkr) = plukluzvhy abjuhlcuij (ugxjknfvgd )
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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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