Drugs / Degludec
Degludec
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03789578 | Jan → Oct 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03336528 | Jan 2018 → Mar 2021 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05036876 | Oct 2021 → Mar 2022 | type 2 diabetes mellitus | Medanta, The Medicity, India | Completed | No outcome recorded |
| — | NCT03001323 | Jan 2017 → Jan 2019 | diabetes mellitus | Hennepin Healthcare Research Institute | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06945406 Comparator | May 2025 → Dec 2026 expected | type 1 diabetes mellitus, type 2 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07215312 Comparator | Oct 2025 → Nov 2026 expected | type 2 diabetes mellitus | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02033889 Background | Dec 2013 → Aug 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT04196231 Comparator | Nov 2019 → Sep 2020 | type 2 diabetes mellitus | University of Campania Luigi Vanvitelli | Completed | No outcome recorded |
| Phase 4 | NCT04664764 Comparator | Feb 2019 → Feb 2021 | type 1 diabetes mellitus | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT04409587 Comparator | Apr 2018 → May 2020 | type 1 diabetes mellitus | Mountain Diabetes and Endocrine Center | Completed | No outcome recorded |
| Phase 4 | NCT02767596 Background | Jul 2016 → Feb 2017 | type 2 diabetes mellitus | Laniado Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT03463564 Comparator | Jan 2016 → Dec 2026 expected | type 1 diabetes mellitus | University of Campania Luigi Vanvitelli | Recruiting | No outcome recorded |
Press releases naming this drug 37 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-10 | Novo Nordisk A/S | Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec novonordisk.com ↗ |
| 2024-03-21 | Novo Nordisk A/S | Awiqli® (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities novonordisk.com ↗ |
| 2022-10-03 | Novo Nordisk A/S | Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people with type 2 diabetes in ONWARDS 5 phase 3a trial novonordisk.com ↗ |
| 2022-07-29 | Novo Nordisk A/S | Novo Nordisk achieves primary objectives of ONWARDS 3 and 4 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin degludec in ONWARDS 3 novonordisk.com ↗ |
| 2022-06-03 | Novo Nordisk A/S | Novo Nordisk achieves primary objectives of ONWARDS 1 and 6 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin glargine U100 in ONWARDS 1 novonordisk.com ↗ |
| 2022-04-28 | Novo Nordisk A/S | Once-weekly insulin icodec demonstrates superior reduction in HbA1c vs insulin degludec in people with type 2 diabetes in ONWARDS 2 phase 3a trial novonordisk.com ↗ |
| 2016-05-20 | Novo Nordisk A/S | FDA offentliggør briefingmateriale forud for møde i rådgivende komite om IDegLira, en kombination af insulin degludec og liraglutid novonordisk.com ↗ |
| 2016-05-20 | Novo Nordisk A/S | FDA posts briefing materials prior to Advisory Committee meeting for IDegLira, a fixed combination product of insulin degludec and liraglutide novonordisk.com ↗ |
| 2013-01-21 | Novo Nordisk A/S | Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗ |
| 2012-12-25 | Novo Nordisk A/S | Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗ |
| 2012-12-25 | Novo Nordisk A/S | Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗ |
| 2012-12-03 | Novo Nordisk A/S | Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗ |
| 2012-12-03 | Novo Nordisk A/S | Ryzodeg® (insulin degludec/insulin aspart) passerer evaluering i japansk medicinkomite novonordisk.com ↗ |
| 2012-11-08 | Novo Nordisk A/S | Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart novonordisk.com ↗ |
| 2012-11-08 | Novo Nordisk A/S | Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗ |
| 2012-11-06 | Novo Nordisk A/S | FDA offentliggør briefingmateriale forud for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗ |
| 2012-11-06 | Novo Nordisk A/S | FDA posts briefing materials prior to Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗ |
| 2012-10-25 | Novo Nordisk A/S | FDA offentliggør fokus for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗ |
| 2012-10-25 | Novo Nordisk A/S | FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗ |
| 2012-10-19 | Novo Nordisk A/S | Novo Nordisk modtager positive udtalelser om Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) fra de europæiske registreringsmyndigheder novonordisk.com ↗ |
| 2012-10-19 | Novo Nordisk A/S | Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) receive positive opinions from the European regulatory authorities novonordisk.com ↗ |
| 2012-09-28 | Novo Nordisk A/S | Novo Nordisk A/S: Tresiba® (insulin degludec) approved in Japan novonordisk.com ↗ |
| 2012-09-28 | Novo Nordisk A/S | Novo Nordisk A/S: Tresiba® (insulin degludec) godkendt i Japan novonordisk.com ↗ |
| 2012-08-31 | Novo Nordisk A/S | Novo Nordisk A/S : Insulin degludec passerer evalueringen i japansk medicinkomite novonordisk.com ↗ |
| 2012-08-31 | Novo Nordisk A/S | Novo Nordisk A/S : Insulin degludec passed the review by the First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗ |
| 2012-07-18 | Novo Nordisk A/S | Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗ |
| 2012-07-18 | Novo Nordisk A/S | Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗ |
| 2012-06-08 | Novo Nordisk A/S | Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗ |
| 2012-06-08 | Novo Nordisk A/S | Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗ |
| 2011-12-22 | Novo Nordisk A/S | Novo Nordisk indsender registreringsansøgning for den ultralangtidsvirkende insulinanalog, Degludec, i Japan novonordisk.com ↗ |
| 2011-12-22 | Novo Nordisk A/S | Novo Nordisk files for regulatory approval of the ultra-long-acting insulin Degludec in Japan novonordisk.com ↗ |
| 2011-09-29 | Novo Nordisk A/S | Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in the US novonordisk.com ↗ |
| 2011-09-29 | Novo Nordisk A/S | Novo Nordisk indsender registreringsansøgning for de ultralangtidsvirkende insulinpræparater Degludec og DegludecPlus i USA novonordisk.com ↗ |
| 2011-09-26 | Novo Nordisk A/S | Novo Nordisk indsender registreringsansøgning for de ultralangtidsvirkende insulinpræparater Degludec og DegludecPlus i Europa novonordisk.com ↗ |
| 2011-09-26 | Novo Nordisk A/S | Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe novonordisk.com ↗ |
| 2010-12-22 | Novo Nordisk A/S | Degludec giver væsentligt nedsat risiko for natlig hypoglykæmi sammenlignet med insulin glargin i to langtidsstudier novonordisk.com ↗ |
| 2010-12-22 | Novo Nordisk A/S | Degludec significantly reduces risk of hypoglycaemia during the night compared to insulin glargine in two long-term studies novonordisk.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Degludec | “Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or...” NCT03463564 ↗10“Instead of receiving their normal basal insulin via CSII, the subject will injected degludec once or twice daily from an insulin pen for your basal insulin.” NCT04409587 ↗ “Patients in this arm will continue the basal insulin (glargine, degludec or glargine-300) used before the randomization.” NCT04196231 ↗ “Glargine, Detemir, Degludec” NCT02767596 ↗ “Degludec” NCT02033889 ↗ |
| Known as | degludec insulin | “Discharge on once a day degludec insulin by pen (supplied by Novo) at dose 0.3 U/kg with reduction to 0.2 U/kg for GFR \<30 ml/hr.” NCT03001323 ↗ |
| Known as | Icodec | “received single subcutaneous injections of IcoSema (175 U icodec, 0.5 mg semaglutide), icodec (175 U) or semaglutide (0.5 mg) with 6-9 weeks' washout.” PMID 39488821 ↗ Nov 2024 |
| Known as | IDeg | “Insulin degludec (IDeg) is a new-generation basal insulin with an ultra-long duration of action.” PMID 22594461 ↗ Jun 2012 |
| Known as | insulin degludec | “Supply adequate insulin degludec until next visit.” NCT03001323 ↗ |
| Modality | Protein / enzyme biologic | “Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.” NCT03336528 ↗ |
| Route | Subcutaneous | “Administered SC” NCT06945406 ↗ |