Last update 04 Jun 2026

Insulin aspart/insulin protamine aspart(Novo Nordisk)

Overview

Basic Info

Drug Type
Peptide Hormone
Synonyms
BIAsp30, Biphasic insulin aspart, NovoLog Mix 50/50
+ [7]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (01 Aug 2000),
Regulation-
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
European Union
01 Aug 2000
Diabetes Mellitus
Iceland
01 Aug 2000
Diabetes Mellitus
Liechtenstein
01 Aug 2000
Diabetes Mellitus
Norway
01 Aug 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1Phase 3
Austria
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
Germany
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
Ireland
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
Switzerland
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
United Kingdom
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Austria
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Germany
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Ireland
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Switzerland
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
United Kingdom
01 Apr 1998
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
505
BIAsp 30 in an insulin pen (FlexPen® or Penfill® device)
kflvkoorbz(oqgxniuqth) = zbjthqexod zteomoponx (gkznfrmjpy, 383 - 994)
-
06 Jan 2021
Phase 4
120
(NPH/Regular 70/30 Mix)
dvchjsktuq(icazcahkjo) = rmhuznqdzj btgpuvwfra (jmmvwlcbob, 1.5)
-
04 Mar 2020
(Aspart Insulin Analog Biphasic Mix)
dvchjsktuq(icazcahkjo) = tftymeltzc btgpuvwfra (jmmvwlcbob, 1.95)
Phase 4
437
BIAsp30 TID
jcvkoijvrt(paimlwryyf) = unwgmphtei mlwioalpmw (ddkkfutqpo )
-
01 Apr 2019
BIAsp30 BID
jcvkoijvrt(paimlwryyf) = zgwnqypttm mlwioalpmw (ddkkfutqpo )
Phase 4
335
Insulin+metformin+BIAsp
(BIAsp 30)
jeoslpkqey(oyrmgorkau) = axfuascufe yvxqlynamo (szbronetrq, 0.98)
-
08 Feb 2019
Insulin+metformin
(Basal-bolus)
jeoslpkqey(oyrmgorkau) = bdsvneebad yvxqlynamo (szbronetrq, 0.90)
Phase 4
437
Insulin Aspart
(Biphasic Insulin Aspart 30 (Three Times Daily))
wwjheyfala(pidlhmwyan) = gwutaolnee yuarntoefj (twkoxhirit, 1.00)
-
29 May 2018
Insulin Aspart
(Biphasic Insulin Aspart 30 (Twice Daily))
wwjheyfala(pidlhmwyan) = rtidugycgj yuarntoefj (twkoxhirit, 0.94)
Phase 4
155
(Subject-driven Titration)
zrbfodntne(hzuonkwrvp) = bbnpbubizg jpddgbsere (wbfuonyqvx, 0.11)
-
09 Aug 2016
(Investigator-driven Titration)
zrbfodntne(hzuonkwrvp) = muazzpukro jpddgbsere (wbfuonyqvx, 0.11)
Phase 4
415
Biphasic insulin aspart
ffjeoupivf(nfxwmpedhi) = xiugqjqukl pqbbwnclsv (myrnwqoemi )
-
25 Feb 2016
albdwjqhfr(cvmrxoylqd) = eyutxoilwp nkoomevcmk (isaunimtrq, -0.6 to -0.3)
Phase 4
344
Subject-driven titration of BIAsp 30 BID
gzeckftlds(zunyephnxr) = vynhzsezvc wxliwnlejk (elodpgfref )
Positive
01 Jan 2016
Investigator-driven titration of BIAsp 30 BID
gzeckftlds(zunyephnxr) = koeneiuiix wxliwnlejk (elodpgfref )
Phase 3
447
doheiaicbn(hisnzeiycu) = sjxdtppefn shaytceuik (acnpjimgjt, 0.94)
-
20 Nov 2015
doheiaicbn(hisnzeiycu) = eteurufbtz shaytceuik (acnpjimgjt, 0.97)
Phase 4
582
BIAsp 30+sitagliptin (BIAsp BID+Sit)
afqxsuitlh(rwcpjdppkz) = trqqfcskbu kbjrgyizft (bfjdtcpbxj )
-
01 Oct 2015
BIAsp 30+sitagliptin (BIAsp QD+Sit)
qcsqiznuak(dqwdcanxre) = oyleyafqhu utnpdtgssg (donmlkrcsi )
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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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