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insulin detemir

Trade name: Levemir

Recombinant proteinapproved

Approved

Jun 16, 2005

Insulin detemir, a long-acting human insulin analog, is sold under the brand name LEVEMIR to improve glycemic control in adults and children with diabetes mellitus. Insulin detemir binds to the insulin receptor. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. The primary activity of insulin detemir is the regulation of glucose metabolism. Insulin detemir crosses the BBB and reduces food intake, it improves weight management by an enhanced and prolonged centrally mediated reduction of energy intake. — NCATS

Clinical trial activity

134 trials · 70 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
51
Phase 3
49
Phase 4
51

Earliest trial started Sep 1, 1999 (NCT00000620)

Timeline

1990s

  1. Jan 1, 1999

    Novo Nordisk — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jun 16, 2005

    Novo Nordisk — Earliest FDA Approval

  2. Jun 16, 2005

    Novo Nordisk — NDA Secondary Org

  3. Jun 16, 2005

    Novo Nordisk — NDA Organization

  4. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 16, 2005

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Mol. weight
5916.93 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • detemir
  • detemir
  • ins levemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin detemir
  • insulin,detemir,human
  • insulin detemir [rdna origin]
  • insulin detemir recombinant
  • insulin detemir recombinant
  • insulin detemir recombinant
  • insulin detemir recombinant
  • insulin detemir recombinant
  • insuline detemir
  • insulin levemir
  • levemir
  • levemir
  • levemir
  • levemir
  • levemir flexpen
  • levemir flexpen
  • levemir innolet
  • levemir innolet
  • levemir penfill
  • levemir penfill
  • nn304
  • nn 304
  • nn-304
  • nn-304
  • nn-304

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05134987Phase 1Dec 1, 2021Novo Nordisk
NCT05124457Phase 2Nov 30, 2021University of California, Los Angeles
NCT04416269Phase 4Jun 30, 2020Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT03620890Phase 4Sep 3, 2018University of Texas at Houston
NCT03377699Phase 3Nov 22, 2017Novo Nordisk
NCT04222348Phase 3Oct 26, 2016Government of Spain
NCT02741687Phase 4Jun 1, 2016Emory University
NCT02967211Phase 4Dec 1, 2015Sanofi
NCT02967224Phase 4Nov 1, 2015Sanofi
NCT02496780Phase 2/Phase 3 (Phase 3)Aug 1, 2015University of Minnesota
NCT02451137Phase 4Jun 16, 2015Sanofi
NCT01966978Phase 4Nov 1, 2014The University of Texas, Dallas
NCT02824510N/AAug 1, 2014Université catholique de Louvain
NCT02131272Phase 3Jun 1, 2014Novo Nordisk
NCT01835431Phase 3Oct 1, 2013Novo Nordisk
NCT01831765Phase 3Aug 31, 2013Novo Nordisk
NCT01868542Phase 4Jun 1, 2013Novo Nordisk
NCT02048189Phase 4Mar 1, 2012University of Burgundy
NCT01461616Phase 3Feb 1, 2012Aarhus University
NCT01513473Phase 3Jan 1, 2012Novo Nordisk
Showing 20 of 134 trials
Page 1 / 7

Organizations

Research & Development (70)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Novo NordiskFor profit947351999
SanofiFor profit5522005
Eli LillyFor profit3212007
Emory UniversityAcademic/Hospital3312006
Rush UniversityAcademic/Hospital3122006
Steno Diabetes Center CopenhagenAcademic/Hospital3312007
The University of Texas, DallasAcademic/Hospital3322006
Aarhus UniversityAcademic/Hospital2222005
Diabetes Care CenterAcademic/Hospital2212006
Medical University of GrazAcademic/Hospital2122007
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2021999
National Institute on Aging (NIA)Government2021999
Ohio State UniversityAcademic/Hospital2222008
The Royal Bournemouth HospitalAcademic/Hospital2222005
University of CopenhagenAcademic/Hospital2112008
University of TuebingenAcademic/Hospital2222006
Wake Forest UniversityAcademic/Hospital2121999
AbbottFor profit1012010
Alzheimer's AssociationAcademic/Hospital1012011
AstraZenecaFor profit1112009
70 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
Novo NordiskFor profitSYNOct 19, 2005
Novo NordiskFor profitNDA2Jun 16, 2005
Novo NordiskFor profitNDAJun 16, 2005