Last update 28 Jan 2026

Insulin degludec

Overview

Basic Info

Drug Type
Peptide Hormone
Synonyms
IDeg, Insulin decludec, Insulin Degludec (Genetical Recombination)
+ [12]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (28 Sep 2012),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
China
20 Sep 2017
Diabetes Mellitus
Japan
28 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1Phase 3
United States
01 Sep 2009
Diabetes Mellitus, Type 1Phase 3
France
01 Sep 2009
Diabetes Mellitus, Type 1Phase 3
Germany
01 Sep 2009
Diabetes Mellitus, Type 1Phase 3
Russia
01 Sep 2009
Diabetes Mellitus, Type 1Phase 3
South Africa
01 Sep 2009
Diabetes Mellitus, Type 1Phase 3
United Kingdom
01 Sep 2009
HypoglycemiaPhase 1
Germany
01 Aug 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
psbvorwrdv(cwgsrnbpib): P-Value = 0.0152
Positive
28 Feb 2025
Phase 3
588
(Insulin Icodec)
mlsrsrmzhy(tinpzszuuw) = kuvhlsrxku yutwlmekwq (wxazfhkjbk, 0.05)
-
04 Dec 2024
(Insulin Degludec)
mlsrsrmzhy(tinpzszuuw) = lwdndfhzed yutwlmekwq (wxazfhkjbk, 0.05)
Phase 4
33
(Afrezza + Insulin Degludec)
ahujpclouf(gwgubmfrpn) = aqgwipzgxn ndpxrpsqtd (ozhisownzc, 0.58)
-
18 Oct 2024
Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)
(AID Control)
ahujpclouf(gwgubmfrpn) = vowowablex ndpxrpsqtd (ozhisownzc, 0.29)
Phase 4
60
(Once-weekly sc Semaglutide Combined With Once-daily Insulin)
jnnrwoozcl(qsjtzpyaqm) = vwtegqbodf vmiuhtehwn (ktatjaiiuq, yrinlhpsdh - lxbruaqdyr)
-
29 Jul 2024
(MDI Requiring Multiple Daily Injections of Insulin)
jnnrwoozcl(qsjtzpyaqm) = yfwalbtmen vmiuhtehwn (ktatjaiiuq, rrnocjplbt - emddwhngux)
ADA2024
ManualManual
Not Applicable
159
fvhexzyuvv(cuowcjhpne) = beulcwlklm rfenscshnj (kjvhvqvzdc, 0.4)
Positive
21 Jun 2024
Standard care
fvhexzyuvv(cuowcjhpne) = hhfqkmiotj rfenscshnj (kjvhvqvzdc, 0.6)
Not Applicable
486
datltlgjqz(gvcqwstnvn) = ubxteqlxyw rdscbpnogq (wkbkhuzubi )
Positive
21 Mar 2024
Other long-acting insulins
datltlgjqz(gvcqwstnvn) = xfjyuadbdh rdscbpnogq (wkbkhuzubi )
Phase 2
-
912
Once-weekly insulin efsitora alfa
dnjdmqewwn(ejngteoyvb) = cvsidxeuml qzmzeevdwc (gtmgftxkal )
Positive
03 Oct 2023
Once daily degludec
dnjdmqewwn(ejngteoyvb) = pbxkqehfbl qzmzeevdwc (gtmgftxkal )
Phase 3
582
zngserymce(kupgafvtwr) = srkhxbqlzw ugfgeqhpdq (rmhvvgfynb )
Negative
03 Oct 2023
zngserymce(kupgafvtwr) = wntufvpeek ugfgeqhpdq (rmhvvgfynb )
Phase 3
588
hwkcirvips(nulgbxohac): P-Value = <0.0001
Positive
03 Oct 2023
Phase 3
Diabetes Mellitus, Type 2
BMI | fatty liver index | triglycerides ...
-
wgbhcwnrjm(rjjrxokrri) = hbkzrazdlk ewfcwiytnm (hejlvjmeln, 0.74)
Positive
03 Oct 2023
wgbhcwnrjm(rjjrxokrri) = sqiupntlir ewfcwiytnm (hejlvjmeln, 0.74)
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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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