Drugs / Degludec
Degludec
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetes mellitus, noninsulin-dependent, 2 3 milestones | |||||
| Filed | Japan (PMDA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2011-12-22 | “indsendt ansøgning til de japanske sundhedsmyndigheder, Pharmaceuticals and Medical Devices Agency (PMDA), om godkendelse af den ultralangtidsvirkende insulinanalog, Degludec.” novonordisk.com ↗ “submission to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, of a new drug application for the approval of ultra-long-acting insulin Degludec.” novonordisk.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2011-09-29 | “submission to the US Food and Drug Administration of two new drug applications for the approval of ultra-long-acting insulin Degludec” novonordisk.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2011-09-26 | “indsendt to ansøgninger om markedsføringstilladelse til Det Europæiske Lægemiddelagentur med henblik på godkendelse af den ultralangtidsvirkende insulinanalog Degludec” novonordisk.com ↗ “submission to the European Medicines Agency of two marketing authorisation applications for the approval of ultra-long acting insulin Degludec” novonordisk.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | US (FDA) | Tresiba® | — | 2015-04-07 | “the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec)” novonordisk.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Enrollment |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT06945406 Comparator | May 2025 → Mar 2027 expected | type 1 diabetes mellitus, type 2 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT07215312 Comparator | Oct 2025 → Nov 2026 expected | type 2 diabetes mellitus | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02033889 Background | Dec 2013 → Aug 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| Phase 4 | NCT03463564 Comparator | Jan 2016 → Dec 2026 expected | type 1 diabetes mellitus | University of Campania Luigi Vanvitelli | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 58
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2 ganlee.com ↗
After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c) * compared with once-daily insulin glargine U100 (Lantus ® ) and once-daily insulin degludec (Tresiba ® ). |
| 2026-03-26 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes novonordisk.com ↗
Awiqli® (insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDA |
| 2026-03-26 | Novonordisk Us | Regulatory FDA approves Novo Nordisk's Awiqli®, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes novonordisk-us.com ↗
FDA approves Novo Nordisk's Awiqli®, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes |
| 2024-09-29 | Gan and Lee Pharmaceuticals, USA | Results [EASD 2024 Highlights] Once-weekly Insulin GZR4 ganlee.com ↗
After six weeks of treatment with once-weekly GZR4, patients with T2DM showed superior glycemic control compared to those receiving insulin degludec. |
| 2024-07-10 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus. |
| 2022-10-03 | Novo Nordisk A/S | Results 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 ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. |
| 2022-07-29 | Novo Nordisk A/S | Results 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 ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared with insulin degludec. |
| 2022-04-28 | Novo Nordisk A/S | Results 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 ↗
From an overall baseline HbA1c of 8.13%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of 0.93% compared to 0.71% for insulin degludec (estimated treatment difference: -0.22%). |
| 2018-03-26 | Novo Nordisk A/S | Regulatory FDA godkender opdatering af indlægssedlen for Tresiba® med data for forekomsten af hjerte-kar-sygdom og alvorlig hypoglykæmi novonordisk.com ↗
Bagsværd, den 26. marts 2018 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har godkendt en opdatering af den amerikanske ordineringsinformation for Tresiba® (insulin degludec), så den også omfatter data fra DEVOTE-studiet. |
| 2018-03-26 | Novo Nordisk A/S | Regulatory FDA approves inclusion of data on cardiovascular outcomes and severe hypoglycaemia in the Tresiba® label novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an update to the US prescribing information for Tresiba® (insulin degludec) to include data from the DEVOTE trial. |
| 2017-09-29 | Novo Nordisk A/S | Regulatory CHMP støtter opdatering af indlægssedlen for Tresiba® i EU - ny indlægsseddel afspejler signifikant reduktion i risikoen for alvorlig hypoglykæmi novonordisk.com ↗
Med CHMP's støtte til den opdaterede indlægsseddel for Tresiba® har vi passeret en vigtig milepæl indenfor insulinbehandling. |
| 2017-09-29 | Novo Nordisk A/S | Regulatory CHMP endorses Tresiba® label update in the EU - new label reflects significant reduction in the risk of severe hypoglycaemia novonordisk.com ↗
With the CHMP's endorsement of the updated label for Tresiba® we have passed a major milestone in insulin therapy. |
| 2017-06-14 | Novo Nordisk A/S | Regulatory Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba® label novonordisk.com ↗
Novo Nordisk today announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for including data in the label for Tresiba® (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes. |
| 2017-06-14 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender ansøgning i EU om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt en type II-variationsansøgning til Det Europæiske Lægemiddelagentur (EMA) om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba® (insulin degludec). |
| 2017-05-27 | Novo Nordisk A/S | Regulatory Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label novonordisk.com ↗ |
| 2017-05-27 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender ansøgning i USA om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt en supplerende ansøgning til de amerikanske sundhedsmyndigheder, FDA, om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba®. |
| 2017-03-24 | Novo Nordisk A/S | Regulatory CHMP provides positive opinion for EU label update for Novo Nordisk's Tresiba® based on data from SWITCH trials novonordisk.com ↗
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive opinion, recommending an update of the label for Tresiba® (insulin degludec) to include data from the SWITCH 1 and 2 clinical trials. |
| 2017-03-24 | Novo Nordisk A/S | Regulatory CHMP afgiver positiv udtalelse om opdatering af indlægssedlen for Novo Nordisks Tresiba® i EU baseret på data fra SWITCH-studierne novonordisk.com ↗
For SWITCH 1-studiet anbefaler CHMP, at indlægssedlen opdateres med resultater, som afspejler de signifikante reduktioner i hypoglykæmi. |
| 2016-11-29 | Novo Nordisk A/S | Results Novo Nordisk A/S: Tresiba® demonstrates a safe cardiovascular profile and reduces the risk of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial novonordisk.com ↗
The trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. |
| 2016-11-29 | Novo Nordisk A/S | Results Novo Nordisk A/S: Tresiba® viser en sikker kardiovaskulær profil og reducerer risikoen for alvorlig hypoglykæmi sammenlignet med insulin glargin U100 i DEVOTE-studiet novonordisk.com ↗ |
| 2016-09-23 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender ansøgning i USA om inkludering af data fra de to SWITCH-studier i indlægssedlen for Tresiba® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt en supplerende ansøgning til de amerikanske sundhedsmyndigheder, FDA, med henblik på inkludering af data fra de to fase 3b-SWITCH-studier i indlægssedlen for Tresiba®. |
| 2016-09-23 | Novo Nordisk A/S | Regulatory Novo Nordisk submits application in the US for including data from the two SWITCH trials in Tresiba® label novonordisk.com ↗
Novo Nordisk today announced the submission of a supplemental application to the US Food and Drug Administration (FDA) for including data from the two SWITCH phase 3b trials in the label for Tresiba®. |
| 2016-02-23 | Novo Nordisk A/S | Results Tresiba® viser signifikant lavere forekomst af hypoglykæmi end insulin glargin U100 i blindet fase 3b-studie i mennesker med type 1-diabetes novonordisk.com ↗
Studiet opfyldte sit primære mål, idet det viste ikke-inferiøritet med hensyn til forekomsten af alvorlig eller symptomatisk hypoglykæmi bekræftet ved blodsukkermåling for Tresiba® sammenlignet med insulin glargin. |
| 2016-02-23 | Novo Nordisk A/S | Results Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine U100 in blinded phase 3b trial in people with type 1 diabetes novonordisk.com ↗
The observed rate was 2,201 events per 100 patient years exposed to Tresiba® and 2,463 events per 100 patient years exposed to insulin glargine during the maintenance period, corresponding to a statistically significant reduction of 11%. |
| 2016-01-29 | Novo Nordisk A/S | Results Tresiba® viser signifikant lavere forekomst af hypoglykæmi end insulin glargin i blindet fase 3b-studie i mennesker med type 2-diabetes novonordisk.com ↗
Den observerede forekomst af alvorlig eller symptomatisk hypoglykæmi bekræftet ved blodsukkermåling var 186 episoder pr. 100 patientårs eksponering for Tresiba® og 265 episoder pr. 100 patientårs eksponering for insulin glargin i vedligeholdelsesperioden. |
| 2016-01-29 | Novo Nordisk A/S | Results Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine in blinded phase 3b trial in people with type 2 diabetes novonordisk.com ↗
This reduction was statistically significant, and the trial thus met its primary endpoint by demonstrating a reduction of 30% when people were treated with Tresiba® compared to insulin glargine. |
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗
Bagsværd, den 25. september 2015 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) efter at have afsluttet behandlingen af de genindsendte registreringsansøgninger har godkendt Tresiba® og Ryzodeg® 70/30 til behandling af diabetes hos voksne. |
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30 novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs). |
| 2015-04-07 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗
Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling som en 'Class II Resubmission'. |
| 2015-04-07 | Novo Nordisk A/S | Regulatory US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗
Bagsværd, Denmark, 10 February 2013 - Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
Bagsværd, den 21. januar 2013 - Novo Nordisk meddelte i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes hos voksne. |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes in adults. |
| 2012-12-25 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗
Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes. |
| 2012-11-08 | Novo Nordisk A/S | Regulatory 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 | Regulatory Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗ |
| 2012-10-18 | Novo Nordisk A/S | Regulatory Japansk lægemiddelagentur offentliggør evalueringsrapport om Tresiba® novonordisk.com ↗
Novo Nordisk meddelte i dag, at det japanske lægemiddelagentur, Pharmaceuticals and Medical Devices Agency (PMDA), har offentliggjort deres evalueringsrapport om Tresiba® (insulin degludec). |
| 2012-09-28 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Tresiba® (insulin degludec) approved in Japan novonordisk.com ↗
Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Tresiba® (insulin degludec) for the treatment of diabetes. |
| 2012-09-28 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Tresiba® (insulin degludec) godkendt i Japan novonordisk.com ↗
Novo Nordisk meddelte i dag, at det japanske ministerium for sundhed, arbejde og velfærd har godkendt Tresiba® (insulin degludec) til behandling af diabetes. |
| 2012-08-31 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S : Insulin degludec passerer evalueringen i japansk medicinkomite novonordisk.com ↗
Novo Nordisk meddelte i dag, at insulin degludec har passeret evalueringen i en medicinsk komite under de japanske sundhedsmyndigheder, First Committee on Drugs of Pharmaceutical Affairs. |
| 2012-08-31 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S : Insulin degludec passed the review by the First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗
Novo Nordisk today announced that insulin degludec has passed the review by the First Committee on Drugs of Japan's Pharmaceutical Affairs. |
| 2012-07-18 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
Novo Nordisk meddelte i dag, at de amerikanske sundhedsmyndigheder, FDA, har oplyst, at man vil afholde et møde i FDA's rådgivende komite, hvor registreringsansøgningerne for ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart vil blive drøftet. |
| 2012-07-18 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has informed the company that an FDA Advisory Committee meeting is tentatively scheduled to be held on 8 November 2012 to discuss the New Drug Applications (NDA) for the ultra-long-acting insulin degludec and insulin degludec/insulin aspart. |
| 2012-06-08 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗
Novo Nordisk har i dag meddelt, at de amerikanske sundhedsmyndigheder (FDA) har forlænget registreringssprocessen for den ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart til behandling af type 1- og type 2-diabetes. |
| 2012-06-08 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes. |
| 2011-12-22 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for den ultralangtidsvirkende insulinanalog, Degludec, i Japan novonordisk.com ↗
Novo Nordisk meddelte i dag, at virksomheden har indsendt ansøgning til de japanske sundhedsmyndigheder, Pharmaceuticals and Medical Devices Agency (PMDA), om godkendelse af den ultralangtidsvirkende insulinanalog, Degludec. |
| 2011-12-22 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of the ultra-long-acting insulin Degludec in Japan novonordisk.com ↗
Novo Nordisk today announced the submission to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, of a new drug application for the approval of ultra-long-acting insulin Degludec. |
| 2011-11-07 | Novo Nordisk A/S | Results Novo Nordisk A/S: DegludecPlus giver bedre blodsukkerregulering end insulin glargin i et fase 3a-studie med japanske type 2-diabetikere novonordisk.com ↗ |
| 2011-11-07 | Novo Nordisk A/S | Results Novo Nordisk A/S: DegludecPlus provides superior glycaemic control compared to insulin glargine in a phase 3a trial in Japanese people with type 2 diabetes novonordisk.com ↗ |
| 2011-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in the US novonordisk.com ↗
Novo Nordisk today announced the submission to the US Food and Drug Administration of two new drug applications for the approval of ultra-long-acting insulin Degludec and the insulin combination analogue DegludecPlus, respectively. |
| 2011-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for de ultralangtidsvirkende insulinpræparater Degludec og DegludecPlus i USA novonordisk.com ↗
Novo Nordisk meddelte i dag, at virksomheden har indsendt to registreringsansøgninger til de amerikanske sundhedsmyndigheder, FDA, med henblik på godkendelse af den ultralangtidsvirkende insulinanalog Degludec og kombinationsanalogen DegludecPlus. |
| 2011-09-26 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for de ultralangtidsvirkende insulinpræparater Degludec og DegludecPlus i Europa novonordisk.com ↗
Novo Nordisk meddelte i dag, at virksomheden har indsendt to ansøgninger om markedsføringstilladelse til Det Europæiske Lægemiddelagentur med henblik på godkendelse af den ultralangtidsvirkende insulinanalog Degludec og kombinationsanalogen DegludecPlus. |
| 2011-09-26 | Novo Nordisk A/S | Regulatory Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe novonordisk.com ↗
Novo Nordisk today announced the submission to the European Medicines Agency of two marketing authorisation applications for the approval of ultra-long acting insulin Degludec and the insulin combination analogue DegludecPlus, respectively. |
| 2011-04-28 | Novo Nordisk A/S | Results Novo Nordisks resultat af primær drift steg med 24% i første kvartal af 2011 novonordisk.com ↗
Metaanalysen bekræftede, at Degludec er forbundet med en lavere risiko for hypoglykæmi sammenlignet med insulin glargin, både med hensyn til det samlede antal bekræftede tilfælde af hypoglykæmi og antallet af bekræftede tilfælde af natlig hypoglykæmi. |
| 2011-04-28 | Novo Nordisk A/S | Results Novo Nordisk increased operating profit by 24% in the first quarter of 2011 novonordisk.com ↗
The meta-analysis confirmed that Degludec is associated with a lower risk of hypoglycaemia compared to insulin glargine, both on the total number of confirmed hypoglycaemic events, and on the number of confirmed nocturnal hypoglycaemic events. |
| 2010-12-22 | Novo Nordisk A/S | Results Degludec giver væsentligt nedsat risiko for natlig hypoglykæmi sammenlignet med insulin glargin i to langtidsstudier novonordisk.com ↗
Novo Nordisk har i dag rapporteret kliniske resultater fra to 52-ugers fase 3a treat-to-target-studier, der har sammenlignet Degludec, en ultralangtidsvirkende basal insulin, med insulin glargin i basal/bolus-behandling af type 1- og type 2-diabetes. |
| 2010-12-22 | Novo Nordisk A/S | Results Degludec significantly reduces risk of hypoglycaemia during the night compared to insulin glargine in two long-term studies novonordisk.com ↗
Novo Nordisk today announced clinical results from two 52-week phase 3a treat-to-target studies comparing Degludec, an ultra long-acting basal insulin, to insulin glargine in basal-bolus treatment of type 1 and type 2 diabetes. |
All press releases naming this drug 69 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 12 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 | 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 ↗ |