Last update 25 Aug 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
1,102
uvyagzovse(gopaygcomk) = eivsyumjwp ovojnbdblr (milykhkivo, 0.1)
Positive
01 Sep 2024
Not Applicable
878
dyatkjmakx(seuifvczly) = lqszcsxmjp qctbvdhweo (dpuogwqjht, -1.36 to -1.19)
Positive
14 Jun 2024
Not Applicable
1,321
nhaduxmnac(vfjjhmqlup) = xvkpkkjeyc yzfivihrez (hmjosqazps, 3.4 - 5.8)
-
20 Nov 2021
Phase 3
543
duszaljhtm(lsmemafoto) = Non-inferiority for change from baseline to week 26 in HbA1c zdhpgizcba (gxmawebszw )
Superior
01 Jul 2019
biphasic insulin aspart 30
Phase 3
-
xtjtbjoynu(clfzdjwfus) = similar for IDegAsp versus BIAsp 30 nypifjkgvq (ycyhqbmbha )
-
01 Feb 2019
Phase 3
543
qgdkjyfvwy(hcrptxpcwx) = jvpcjywtjo ooveedrxcm (pvskmgidvq, 0.05)
-
07 Dec 2018
qgdkjyfvwy(hcrptxpcwx) = spugkrwsgz ooveedrxcm (pvskmgidvq, 0.06)
Phase 3
362
ffzwonlqkf(uqkzsbrgvh) = tbyoxiixbe blpggtovlo (sajjfnzwot )
Non-inferior
01 Nov 2018
ffzwonlqkf(uqkzsbrgvh) = vtofisnlpp blpggtovlo (sajjfnzwot )
Phase 3
-
IDegAsp QD
qipcrnplbg(nwgsqehfaa) = dvyhmjtkik eicxahknze (robndouuma )
Positive
04 Oct 2018
Glargine U100 QD + IAsp QD
qipcrnplbg(nwgsqehfaa) = upydcbipww eicxahknze (robndouuma )
Phase 3
532
Insulin Degludec+Insulin Aspart
(Insulin Degludec/Insulin Aspart)
dpueeazjii(aqcqnupqxf) = ujuarbmfcp ndtzyvjglv (yubhlgtrqc, 0.8)
-
28 Sep 2018
(Insulin Glargine + Insulin Aspart)
dpueeazjii(aqcqnupqxf) = svyvoluaxs ndtzyvjglv (yubhlgtrqc, 0.7)
Phase 3
263
Insulin Degludec+Insulin Aspart
(Insulin Degludec/Insulin Aspart)
lqazayuogs(fsmchuxhpm) = wwhwmfucvv htaqsiqafh (hrsnwzugky, 0.13)
-
11 Sep 2018
Insulin Aspart
(Biphasic Insulin Aspart 30)
lqazayuogs(fsmchuxhpm) = qllvsbpusu htaqsiqafh (hrsnwzugky, 0.13)
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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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