Drugs / insulin detemir
last change Aug 2026 re-read 9 days ago

insulin detemir

Protein / enzyme biologic targets INSR via activation

Developed for
type 2 diabetes mellitus · type 1 diabetes mellitus · diabetes mellitus · gestational diabetes · Alzheimer disease · cognitive impairment with or without cerebellar ataxia · cystic fibrosis · cystic fibrosis-related diabetes
+3 more · hyperglycemia · obesity disorder · diabetes mellitus, noninsulin-dependent, 2
Investigated by
Novo Nordisk A/S · Centre Hospitalier Universitaire Dijon · Diabetes Care Center · Lise Tarnow · The Royal Bournemouth Hospital · Abbott
+48 more · Alzheimer's Association · Amsterdam UMC, location VUmc · Bispebjerg Hospital · Centre Europeen d'Etude du Diabete · Children's Hospital Colorado · Copenhagen Trial Unit, Center for Clinical Intervention Research · Emory University · First Affiliated Hospital Xi'an Jiaotong University · Frederiksberg University Hospital · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Herlev Hospital · Hillerod Hospital, Denmark · Hvidovre University Hospital · Indiana University · John Hunter Children's Hospital · Lady Cilento Children's Hospital, Brisbane · McMaster University · Medical University of Graz · Montefiore Medical Center · Montreal Clinical Research Institute · Mountain Diabetes and Endocrine Center · National Institute on Aging (NIA) · Nationwide Children's Hospital · Newcastle University · Northumbria University · Pontificia Universidad Catolica de Chile · Rabin Medical Center · Rigshospitalet, Denmark · St George's, University of London · St. Luke's-Roosevelt Hospital Center · Steno Diabetes Center Copenhagen · Sydney Children's Hospitals Network · Thomas Jefferson University · University Hospital Tuebingen · University Hospital, Gentofte, Copenhagen · University of Aarhus · University of Calgary · University of California, Los Angeles · University of Minnesota · University of New Mexico · University of Padova · University of Rochester · University of Texas Southwestern Medical Center · University of Washington · Vanderbilt University · Wake Forest University Health Sciences · Women's and Children's Hospital, Adelaide · Zealand University Hospital

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) LEVEMIR FLEXTOUCH — 2012-03-29 – 2012-05-18 fda.gov ↗
Approved US (FDA) LEVEMIR FLEXTOUCH — 2005-06-16 fda.gov ↗
Approved EU (EMA) Levemir — 2004-06-01 europa.eu ↗

Trials 93 · started per year

today
EU approved 2004
US approved 2005
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 114 trials
Phase 1 NCT05134987 Dec 2021 → May 2022 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT00873223 Mar → Sep 2009 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT00810589 Nov → Dec 2008 type 1 diabetes mellitus Medical University of Graz Completed No outcome recorded
Phase 1 NCT01498939 Aug → Sep 2007 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01490099 Aug → Nov 2006 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01498926 Nov 2005 → Feb 2006 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01497587 Aug → Dec 2005 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01497574 May → Oct 2005 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01497535 May → Oct 2004 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT00760448 Apr 2004 → Oct 2005 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 24 trials
Phase 2 NCT05124457 Feb 2022 → Jun 2025 overdue gestational diabetes, type 2 diabetes mellitus University of California, Los Angeles Recruiting No outcome recorded
Phase 2 NCT01595646 Nov 2011 → Mar 2015 Alzheimer disease, cognitive impairment with or without cerebellar ataxia Wake Forest University Health Sciences Completed No outcome recorded
Phase 2 NCT01547169 Mar 2011 → Dec 2012 Alzheimer disease, cognitive impairment with or without cerebellar ataxia University of Washington Completed No outcome recorded
Phase 2 NCT00764556 May 2008 → May 2009 chronic obstructive pulmonary disease, hyperglycemia St George's, University of London Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02496780 Aug 2015 → Jul 2022 cystic fibrosis University of Minnesota Terminated No outcome recorded
Phase 2/3 NCT00639626 Aug 2008 → May 2010 cystic fibrosis-related diabetes Nationwide Children's Hospital Terminated No outcome recorded
Phase 333 trials · 11 met primary · 1 missed
Phase 3 NCT04222348 Oct 2016 → May 2020 gestational diabetes, perinatal disease, puerperal disorder Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Unknown No outcome recorded
Phase 3 NCT01461616 Feb → Nov 2012 type 1 diabetes mellitus University of Aarhus Completed No outcome recorded
Phase 3 NCT01513473 Jan 2012 → Jul 2013 type 1 diabetes mellitus Novo Nordisk A/S Completed Met primary
Phase 3 NCT01100892 Dec 2010 → Feb 2023 cystic fibrosis, diabetes mellitus Sydney Children's Hospitals Network Completed Missed primary
Phase 3 NCT00856986 Mar 2009 → Apr 2010 type 2 diabetes mellitus Novo Nordisk A/S Completed Met primary
Phase 3 NCT00789191 Nov 2008 → Aug 2009 type 2 diabetes mellitus Novo Nordisk A/S Completed Met primary
Phase 3 NCT00623194 Feb 2008 → Sep 2009 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 3 NCT00474045 May 2007 → Aug 2010 type 1 diabetes mellitus Novo Nordisk A/S Completed Met primary
Phase 3 NCT00447382 Mar 2007 → Jul 2008 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 3 NCT00435019 Feb 2007 → Sep 2008 type 1 diabetes mellitus Novo Nordisk A/S Completed Met primary
Phase 426 trials · 3 met primary · 3 missed
Phase 4 NCT01868542 Jun 2013 → May 2015 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 4 NCT02048189 Mar 2012 → Feb 2015 — Centre Hospitalier Universitaire Dijon Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT01889914 Jan 2012 → Mar 2015 type 2 diabetes mellitus Centre Hospitalier Universitaire Dijon Unknown No outcome recorded
Phase 4 NCT01654120 Dec 2011 → Nov 2013 type 2 diabetes mellitus Mountain Diabetes and Endocrine Center Completed No outcome recorded
Phase 4 NCT01486966 Nov 2011 → Jun 2012 type 2 diabetes mellitus Novo Nordisk A/S Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT01828970 Jan 2010 → Sep 2012 diabetes mellitus Centre Europeen d'Etude du Diabete Completed No outcome recorded
Phase 4 NCT00909480 May 2009 → Jun 2010 type 2 diabetes mellitus Novo Nordisk A/S Completed Missed primary
Phase 4 NCT00795600 Apr 2009 → Aug 2010 type 2 diabetes mellitus Novo Nordisk A/S Completed Missed primary
Phase 4 NCT00862875 Mar 2009 → Apr 2014 type 2 diabetes mellitus Montreal Clinical Research Institute Completed No outcome recorded
Phase 4 NCT00699686 May 2008 → Mar 2010 cardiovascular disorder, type 2 diabetes mellitus University of Padova Completed No outcome recorded
Phase not applicable14 trials · 1 met primary · 1 missed
— NCT06419777 Sep 2024 → May 2026 overdue gestational diabetes Thomas Jefferson University Recruiting No outcome recorded
— NCT03180281 Jul 2017 → Jan 2020 type 2 diabetes mellitus First Affiliated Hospital Xi'an Jiaotong University Unknown No outcome recorded
— NCT02204839 Jan 2014 → Jan 2015 type 1 diabetes mellitus Northumbria University Completed No outcome recorded
— NCT01974544 May 2013 → Dec 2015 type 2 diabetes mellitus Pontificia Universidad Catolica de Chile Unknown No outcome recorded
— NCT01837680 Mar 2013 → Mar 2015 gestational diabetes, type 2 diabetes mellitus St. Luke's-Roosevelt Hospital Center Completed Met primary
— NCT01232946 Jan 2012 → Sep 2017 type 2 diabetes mellitus Indiana University Completed Missed primary
— NCT01377155 Jun → Dec 2011 type 2 diabetes mellitus Diabetes Care Center Completed No outcome recorded
— NCT01239550 Apr 2011 → Dec 2028 expected diabetes mellitus, obesity disorder Vanderbilt University Active not recruiting No outcome recorded
— NCT00626080 Jan 2009 → Dec 2011 type 1 diabetes mellitus Amsterdam UMC, location VUmc Completed No outcome recorded
— NCT00659165 Apr 2008 → Dec 2010 diabetes mellitus University of New Mexico Completed No outcome recorded
Comparator or background therapy65 trials
Phase 1 NCT06685185 Comparator Nov 2024 → Mar 2026 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01135927 Comparator Jun → Oct 2010 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT01043510 Comparator Jan → Oct 2010 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT00652288 Comparator Apr 2007 → Sep 2011 type 1 diabetes mellitus Yale University Completed No outcome recorded
Phase 2 NCT00841087 Comparator Jan → May 2009 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2012-06-09 Alkermes, Inc. Results Once-Weekly BYDUREON™ Provided Greater Glucose Control, Weight Loss and Lower Risk of Hypoglycemia Compared to Once- or Twice-Daily Levemir® in Type 2 Diabetes alkermes.com ↗
Treatment with BYDUREON also resulted in greater improvement in A1C (-1.3 percentage points) than insulin detemir (-0.88 percentage points).
2005-06-16 Novo Nordisk A/S Regulatory Novo Nordisk receives US approval of Levemir® and becomes the first company with a full range of insulin analogues in the US novonordisk.com ↗
Novo Nordisk announced today that the US Food and Drug Administration (FDA) has granted marketing authorisation for Levemir®, the company's long-acting insulin analogue for the treatment of diabetes.
2005-06-16 Novo Nordisk A/S Regulatory Novo Nordisk opnår FDA-godkendelse af Levemir® og kan dermed som de første tilbyde et fuldt sortiment af insulinanaloger i USA novonordisk.com ↗
Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har givet tilladelse til markedsføring af den langtidsvirkende insulinanalog Levemir® til behandling af diabetes.

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 180 sources stand behind the page.

FieldValueCited text
Known as insulin detemir “A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir)...” NCT01542450 ↗
120

“OBJECTIVE: We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM)...” PMID 26070699 ↗ Jun 2015

“Treatment with insulin detemir and aspart in patients with type 1 diabetes and recurrent severe hypoglycaemia resulted in a clinically significant reduced rate of severe...” PMID 24794703 ↗ May 2014

“The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for...” NCT07112339 ↗

“We performed a non-inferiority trial comparing insulin detemir (Levemir) and biphasic insulin (NovoMix70) to standard care during Ramadan fast in insulin treated type 2...” PMID 26234442 ↗ Jul 2015

“Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.” NCT01850615 ↗

“AIMS: The efficacy of two basal insulins, insulin lispro protamine suspension (ILPS) and insulin detemir, was compared in basal-bolus regimens in Type 1 diabetes.” PMID 20536953 ↗ May 2010

“BACKGROUND: Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn.” PMID 33865836 ↗ Apr 2021

“This protocol addresses a comparison of insulin glargine and insulin detemir for patients evaluated by CGMS.” NCT00457093 ↗

“Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient.” NCT04974528 ↗

“During this arm/phase, patients take insulin Detemir subcutaneously for 3 months.” NCT00699686 ↗

Show 110 more sources

Known as B29Lys(epsilon-tetradecanoyl),desB30 human insulin “We compared the symptoms of hypoglycaemia induced by insulin detemir (NN304) (B29Lys(epsilon-tetradecanoyl),desB30 human insulin) and equally effective doses of neutral...” PMID 19707744 ↗ Aug 2009
Known as B29Lys(ε-tetradecanoyl),desB30 human insulin “insulin detemir (B29Lys(ε-tetradecanoyl),desB30 human insulin)” PMID 22002075 ↗ Oct 2011
Known as detemir “This 52-week multinational, randomised, open-label, parallel-group, non-inferiority trial compared clinical outcomes following supplementation of oral glucose-lowering drugs...” PMID 18204830 ↗ Jan 2008
34

“Discharge on 0.3 U/kg of admission long acting insulin glargine or detemir (provided by diabetes and endocrine clinic) regardless of participant's home insulin regimen at the...” NCT03001323 ↗

“Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination...” NCT01068652 ↗

“To assess weight change when once-daily insulin detemir (detemir) or neutral protamine Hagedorn insulin (NPH) are used in already overweight Type 2 diabetes patients requiring...” PMID 18959604 ↗ Aug 2008

“Used this way, the insulin analogue detemir has been associated with improved glycemic control of a magnitude similar to neutral protamine Hagedorn (NPH), with lower rates of...” PMID 17157113 ↗ Oct 2006

“Insulin detemir (detemir) has previously been shown to be associated with lower within-subject variability compared with other basal insulin preparations in adults with type 1...” PMID 18761644 ↗ Aug 2008

“AIMS: This study assessed the efficacy and safety of once-daily insulin initiation using insulin detemir (detemir) or insulin glargine (glargine) added to existing metformin in...” PMID 23421331 ↗ Mar 2013

“slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.” NCT00564395 ↗

“Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.” NCT01798706 ↗

“insulin detemir (detemir) was noninferior to insulin glargine (glargine) as the basal insulin” PMID 19922879 ↗ Oct 2009

“basal-bolus therapy with insulin detemir (detemir), a new soluble basal insulin analogue” PMID 16842476 ↗ Jul 2006

Show 24 more sources

Known as IDet “OBJECTIVE: This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both...” PMID 22851598 ↗ Jul 2012
9

“The aim of this trial was to evaluate the efficacy and safety of the combination of once-daily insulin detemir (IDet) and sitagliptin (SITA) versus SITA ± sulphonylurea (SU),...” PMID 21205123 ↗ Mar 2011

“Patients were randomized 1:1 (age stratified: 1-<6 years; 6-<12 years; 12-<18 years) to IDegAsp once daily (OD) plus insulin aspart (IAsp) for remaining meals (IDegAsp + IAsp),...” PMID 30014589 ↗ Aug 2018

“This randomised (1:1), multinational, open-labelled, parallel group trial compared insulin detemir (IDet) with neutral protamine Hagedorn (NPH) insulin, in combination with...” PMID 21418455 ↗ Mar 2011

“OBJECTIVE: We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM)...” PMID 26070699 ↗ Jun 2015

“To evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart (IDegAsp) with insulin aspart (IAsp) at other meals compared with basal-bolus...” PMID 22933438 ↗ Aug 2012

“The efficacy and safety of insulin degludec (IDeg) was compared with insulin detemir (IDet), both administered once daily (OD) as basal treatment in participants with type 1...” PMID 24702700 ↗ May 2014

“This treat-to-target study compared the efficacy and safety of insulin detemir (IDet) and insulin glargine (IGla) in a basal-bolus (insulin aspart) regimen in type 2 diabetes.” PMID 19565569 ↗ Sep 2009

“Insulin degludec (IDeg) once-daily was compared with insulin detemir (IDet) once- or twice-daily” PMID 25683037 ↗ Feb 2015

“the long-acting insulin analogues insulin detemir (IDet) and NPH insulin (NPH)” PMID 16918592 ↗ Sep 2006

Known as Ins levemir ChEMBL registry synonym — accepted as the source's own label CHEMBL2104391 ↗
Known as Insulin detemir recombinant ChEMBL registry synonym — accepted as the source's own label CHEMBL2104391 ↗
Known as insulin Detemir: Levemir “insulin detemir (Levemir)” NCT00000620 ↗
1

“insulin Detemir: Levemir” NCT01461616 ↗

Known as Insulin Levemir “Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks” NCT00487240 ↗
Known as Insulin,detemir,human ChEMBL registry synonym — accepted as the source's own label CHEMBL2104391 ↗
Known as Insulina detemir ChEMBL registry synonym — accepted as the source's own label CHEMBL2104391 ↗
Known as Insuline detemir ChEMBL registry synonym — accepted as the source's own label CHEMBL2104391 ↗
Known as Levemir “We performed a non-inferiority trial comparing insulin detemir (Levemir) and biphasic insulin (NovoMix70) to standard care during Ramadan fast in insulin treated type 2...” PMID 26234442 ↗ Jul 2015
22

“Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks.” NCT01232491 ↗

“the patient will receive an additional injection of basal insulin LEVEMIR® : five injections per day” NCT01889914 ↗

“Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®).” NCT05134987 ↗

“basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])” NCT00467649 ↗

“(Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)” NCT02204839 ↗

“Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra” NCT04965051 ↗

“Levemir, durg class: long-acting insulin” NCT02219750 ↗

“Lantus, Levemir, Novolog, Lispro” NCT02811484 ↗

“Lantus, Toujeo, NPH, levemir” NCT02846233 ↗

“Levemir® (insulin detemir)” NCT01868542 ↗

Show 12 more sources

Known as levemir insulin “Drug: levemir insulin” NCT02496780 ↗
Known as NN304 “A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir)...” NCT01542450 ↗
2

“A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With...” NCT00604344 ↗

“We compared the symptoms of hypoglycaemia induced by insulin detemir (NN304) (B29Lys(epsilon-tetradecanoyl),desB30 human insulin) and equally effective doses of neutral...” PMID 19707744 ↗ Aug 2009

Action Activate “enhanced signaling through the insulin receptor” NCT01239550 ↗
1

“Insulin receptor agonist” CHEMBL2104391 ↗

Modality Protein / enzyme biologic “subcutaneous insulin analogues” NCT00135070 ↗
Route Subcutaneous “evening SC injection of detemir” PMID 17157113 ↗ Oct 2006
Target INSR “Insulin receptor agonist” CHEMBL2104391 ↗