insulin degludec
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetes mellitus, congenital autoimmune 2 milestones | |||||
| Filed | EU (EMA) | Tresiba® | diabetes mellitus, congenital autoimmune | 2016-11-10 | “indsendt en type II-variationsansøgning til Det Europæiske Lægemiddelagentur (EMA) med henblik på inkludering af data fra de to fase 3b-SWITCH-studier i indlægssedlen for Tresiba®.” novonordisk.com ↗ “submission of a Type II Variation application to the European Medicines Agency (EMA) for including data in the label for Tresiba®” novonordisk.com ↗ |
| Filed | US (FDA) | Tresiba® | diabetes mellitus, congenital autoimmune | 2016-09-23 | “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...” novonordisk.com ↗ “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®” novonordisk.com ↗ |
| Filed diabetes mellitus, noninsulin-dependent, 2 3 milestones | |||||
| Filed | Japan (PMDA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2011-12-22 | “har 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 | “virksomheden har 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 type 2 diabetes mellitus 2 milestones | |||||
| Filed | EU (EMA) | Tresiba® | type 2 diabetes mellitus | 2017-06-14 | “indsendt en type II-variationsansøgning til Det Europæiske Lægemiddelagentur (EMA) om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba® (insulin degludec).” novonordisk.com ↗ “submission of a Type II Variation application to the European Medicines Agency (EMA) for including data in the label for Tresiba®” novonordisk.com ↗ |
| Filed | US (FDA) | Tresiba® | type 2 diabetes mellitus | 2017-05-27 | “virksomheden har indsendt en supplerende ansøgning til de amerikanske sundhedsmyndigheder, FDA, om inkludering af data fra DEVOTE-studiet i indlægssedlen for Tresiba®.” novonordisk.com ↗ “announced the submission of a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba®” novonordisk.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (4) | US (FDA) | TRESIBA | — | 2016-12-16 – 2022-07-01 | fda.gov ↗ |
| Approved | US (FDA) | TRESIBA | — | 2015-09-25 | fda.gov ↗ |
| Filed | US (FDA) | Tresiba® | — | 2015-04-07 | “US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec)” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | Tresiba® | — | 2013-02-08 | “den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec)” novonordisk.com ↗ “Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec)” novonordisk.com ↗ “For Tresiba®, the Complete Response Letter in the US was a disappointment” novonordisk.com ↗ |
| Approved | EU (EMA) | Tresiba | — | 2013-01-20 | europa.eu ↗ |
Trials 99 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03400501 | Oct 2017 → Jun 2021 | type 1 diabetes mellitus | Yale University | Completed | No outcome recorded |
| Phase 138 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT06449703 | May → Jun 2024 | — | Tonghua Dongbao Pharmaceutical Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT06556641 | Dec 2022 → Feb 2023 | — | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT05576298 | Oct 2021 → Mar 2022 | type 2 diabetes mellitus | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04569994 | Sep 2020 → Jun 2021 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03726125 | Nov 2018 → Sep 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03292185 | Sep 2017 → Jan 2018 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02536859 | Aug 2015 → Apr 2016 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01773798 | Jan → Aug 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01704417 | Oct 2012 → Mar 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01623375 | Jun → Aug 2012 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01590836 | Apr → Jun 2012 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01467414 | Oct → Dec 2011 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01437592 | Sep → Nov 2011 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01193387 | Aug → Nov 2010 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01173926 | Jul → Nov 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01135927 | Jun → Oct 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01154881 | Jun → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01151072 | Jun → Oct 2010 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01114542 | May → Aug 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01076634 | Feb → Jul 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01043510 | Jan → Oct 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01030926 | Dec 2009 → May 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01006057 | Nov 2009 → May 2010 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01002768 | Oct 2009 → Mar 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 1 | NCT00992537 | Oct 2009 → Jan 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00983021 | Sep → Dec 2009 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00964964 | Aug → Sep 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00966368 | Aug → Oct 2009 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00976326 | Aug 2009 → Mar 2010 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00964418 | Aug → Nov 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00961324 | Jul → Oct 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 1 | NCT01868568 | Apr → Aug 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01868529 | Jan → Jun 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01868555 | Dec 2007 → Feb 2008 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01865331 | Dec 2006 → Mar 2007 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01865305 | Sep 2006 → Feb 2007 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01865318 | Sep 2006 → Jan 2007 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01865292 | Aug → Nov 2006 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT04585776 | Oct 2020 → May 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT03938740 | Mar → Dec 2019 | type 1 diabetes mellitus | Diasome Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00841087 | Jan → May 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00612040 | Jan → Jun 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00611884 | Jan → Aug 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03387787 | Jan 2018 → Jan 2020 | type 2 diabetes mellitus | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 341 trials · 24 met primary · 4 missed | ||||||
| Phase 3 | NCT05802862 | Jul 2023 → Aug 2024 | diabetes mellitus | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05767255 | Dec 2022 → Aug 2023 | type 2 diabetes mellitus | Hospital Universitario San Ignacio | Unknown | Met primary |
| Phase 3 | NCT05641337 | Oct 2022 → Dec 2025 | cirrhosis of liver, diabetes mellitus | Huashan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04955834 | Jul 2021 → Dec 2025 | type 2 diabetes mellitus | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04795531 | Mar 2021 → Jun 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT03862716 | Apr 2019 → Jun 2022 | type 2 diabetes mellitus | Population Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT03377699 | Nov 2017 → Dec 2020 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT03172494 | May 2017 → Jun 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT03175120 | May 2017 → Mar 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT03078478 | Mar 2017 → Feb 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT02501161 | Jan 2016 → Oct 2018 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02607306 | Nov 2015 → Dec 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02030600 | Jan 2014 → Dec 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02034513 | Jan 2014 → Jan 2016 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01959529 | Oct 2013 → Oct 2016 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01849289 | Jun 2013 → May 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01880736 | Jun 2013 → Apr 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01814137 | Mar 2013 → Mar 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01713530 | Feb 2013 → Jan 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT01664247 | Oct 2012 → Dec 2013 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01676116 | Aug 2012 → Mar 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01570751 | Apr 2012 → Jan 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01569841 | Apr → Nov 2012 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01513473 | Jan 2012 → Jul 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01392573 | Nov 2011 → Oct 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01388361 | Sep 2011 → Jul 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01364428 | Jun 2011 → Jan 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01336023 | May 2011 → May 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01326026 | Mar → Dec 2011 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01135992 | Jun → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01068665 | Mar → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01079234 | Mar → Nov 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01076647 | Mar → Dec 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT01059799 | Feb → Dec 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01068678 | Feb → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT01074268 | Feb → Dec 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01046110 | Jan → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01006291 | Nov 2009 → Sep 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00972283 | Sep 2009 → Oct 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00982228 | Sep 2009 → Nov 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00982644 | Sep 2009 → Dec 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 411 trials · 3 met primary · 1 missed | ||||||
| Phase 4 | NCT07599891 | Sep 2023 → Mar 2025 | hyperglycemia | Max Healthcare Insititute Limited | Completed | No outcome recorded |
| Phase 4 | NCT05904743 | Jul 2023 → Mar 2024 | type 1 diabetes mellitus | Mannkind Corporation | Completed | Met primary |
| Phase 4 | NCT05243628 | Mar → Oct 2022 | type 1 diabetes mellitus | Mannkind Corporation | Completed | No outcome recorded |
| Phase 4 | NCT04623086 | Feb 2020 → Sep 2022 | type 1 diabetes mellitus | University of Washington | Completed | Missed primary |
| Phase 4 | NCT03987191 | Jan → Oct 2020 | type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT04027023 | Oct 2019 → Apr 2021 | type 2 diabetes mellitus | Sciema UG | Unknown | No outcome recorded |
| Phase 4 | NCT03668808 | Nov 2018 → Sep 2020 | type 1 diabetes mellitus | Sansum Diabetes Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT03687827 | Oct 2018 → Dec 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT03838783 | May 2018 → Apr 2019 | type 1 diabetes mellitus | LMC Diabetes & Endocrinology Ltd. | Unknown | Met primary |
| Phase 4 | NCT03328845 | Jan 2017 → Nov 2020 | type 1 diabetes mellitus | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Completed | No outcome recorded |
| Phase 4 | NCT02192450 | Jan 2015 → Feb 2019 | hypoglycemia, type 1 diabetes mellitus | Nordsjaellands Hospital | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05417841 | Mar 2023 → Aug 2025 | type 2 diabetes mellitus | Beijing Hospital | Completed | No outcome recorded |
| — | NCT04190160 | Nov 2018 → Nov 2019 | type 2 diabetes mellitus | Stefano Rizza | Completed | No outcome recorded |
| Comparator or background therapy56 trials | ||||||
| Phase 1 | NCT07630233 Comparator | Jun → Oct 2026 expected | type 2 diabetes mellitus | The United Bio-Technology (Hengqin) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07376200 Comparator | Feb → Dec 2026 expected | — | Sunshine Lake Pharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07032688 Background | Aug 2025 → Mar 2027 expected | type 2 diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06685185 Comparator | Nov 2024 → Mar 2026 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT06280703 Comparator | May 2024 → Oct 2026 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06288412 Background | Feb 2024 → Mar 2025 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT06132126 Comparator | Nov 2023 → Jun 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06553248 Comparator | Mar → Nov 2023 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT04276428 Comparator | Feb → Nov 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02964104 Comparator | Nov 2016 → Dec 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02148861 Comparator | May 2014 → Jun 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01319240 Comparator | Mar → May 2011 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01865279 Comparator | Dec 2005 → Apr 2006 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT07018453 Comparator | Jul 2025 → Feb 2026 overdue | type 2 diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06202079 Comparator | Aug 2023 → Jul 2024 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 2 | NCT04663282 Comparator | Feb 2021 → May 2022 | type 2 diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04450407 Comparator | Jul 2020 → Oct 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT04450394 Comparator | Jul 2020 → Oct 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT03736785 Comparator | Nov 2018 → Feb 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT07527078 Comparator | Apr 2026 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 3 | NCT06767748 Comparator | Feb 2025 → Feb 2026 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | Met primary |
| Phase 3 | NCT05463744 Comparator | Aug 2022 → May 2024 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05362058 Comparator | Jun 2022 → Apr 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05275400 Comparator | Mar 2022 → May 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04974528 Background | Sep 2021 → Oct 2024 | type 1 diabetes mellitus, type 2 diabetes mellitus | Mannkind Corporation | Completed | No outcome recorded |
| Phase 3 | NCT04848480 Comparator | Apr 2021 → Apr 2022 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT04770532 Comparator | Mar 2021 → Jan 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT04760626 Comparator | Mar 2021 → Aug 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT04588259 Background | Oct 2020 → Jul 2022 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT03952130 Background | May 2019 → Jan 2022 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03952143 Background | May 2019 → Jan 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03740919 Comparator | Apr 2019 → Jul 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03882970 Comparator | Apr 2019 → Dec 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03737240 Comparator | Jan 2019 → Jul 2022 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 3 | NCT03268005 Background | Sep 2017 → Jan 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT03214367 Background | Jul 2017 → Sep 2018 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03214380 Background | Jul 2017 → Aug 2018 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02911948 Comparator | Sep 2016 → Nov 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02500706 Background | May 2016 → Jul 2017 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02670915 Background | May 2016 → Feb 2018 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT07173712 Comparator | Mar 2026 → Jun 2027 expected | type 2 diabetes mellitus | Yanbing Li | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07112339 Comparator | Aug 2025 → Aug 2026 overdue | type 2 diabetes mellitus | Novo Nordisk A/S | Recruiting | No outcome recorded |
| Phase 4 | NCT05552859 Comparator | Dec 2022 → Jul 2023 | impaired renal function disease, type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05218915 Background | Jan 2022 → Oct 2024 | diabetes mellitus, diabetic kidney disease | Elaine Chow | Completed | No outcome recorded |
| Phase 4 | NCT04538352 Background | Jan 2021 → Mar 2023 | type 2 diabetes mellitus | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT04075513 Comparator | Oct 2019 → Sep 2021 | type 1 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 4 | NCT04692415 Comparator | Dec 2018 → Jun 2019 | type 2 diabetes mellitus | University of Split, School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT03349840 Comparator | Jan → Aug 2018 | type 2 diabetes mellitus | Weill Cornell Medical College in Qatar | Terminated | No outcome recorded |
| Phase 4 | NCT03244241 Comparator | Apr 2017 → Apr 2018 | type 2 diabetes mellitus | Merete Bechmann Christensen | Unknown | No outcome recorded |
| Phase 4 | NCT02738151 Comparator | May 2016 → Aug 2017 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 4 | NCT02967211 Comparator | Dec 2015 → Oct 2017 | type 2 diabetes mellitus | Sanofi | Completed | Missed primary |
| Phase 4 | NCT02967224 Comparator | Nov 2015 → Oct 2017 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 4 | NCT02680457 Comparator | Nov 2013 → Jul 2015 | type 2 diabetes mellitus | University of Guadalajara | Completed | No outcome recorded |
| — | NCT06178874 Comparator | Dec 2023 → May 2024 | glucose metabolism disease | Ain Shams University | Completed | No outcome recorded |
| — | NCT04965051 Comparator | Aug 2021 → Dec 2023 | type 1 diabetes mellitus | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT02846233 Comparator | Aug 2016 → Dec 2018 | type 2 diabetes mellitus | University of California, San Francisco | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 55
| 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 ® ). |
| 2025-06-22 | Eli Lilly and Company | Results Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials lilly.com ↗
In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand. |
| 2024-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies ganlee.com ↗
After 16 weeks of treatment in patients with Type 2 diabetes, the once-weekly insulin analog GZR4 injection demonstrated superior HbA1c reduction in patients with uncontrolled diabetes on basal insulins, compared to insulin degludec (Tresiba ® ). |
| 2024-09-30 | Mannkind Corporation | Results More Adults With Type 1 Diabetes Achieved A1C Goal ( mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase. |
| 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. |
| 2024-09-10 | Eli Lilly and Company | Results Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetes lilly.com ↗
For the efficacy estimand1,2, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively3 at 52 weeks. |
| 2024-09-10 | Eli Lilly and Company | Results With once-a-week dosing, insulin efsitora alfa delivers similar A1C reduction compared to daily insulin in adults with type 1 diabetes lilly.com ↗
For the efficacy estimand1,2, efsitora reduced A1C by 0.53% compared to 0.59% for insulin degludec resulting in an A1C of 7.37% and 7.32% respectively3. |
| 2024-09-05 | Eli Lilly and Company | Results In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin lilly.com ↗
The QWINT-3 trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. |
| 2024-05-16 | Eli Lilly and Company | Results With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin lilly.com ↗
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 52. |
| 2022-11-10 | Mannkind Corporation | Results MannKind to Present Two Posters at 22nd Annual Diabetes Technology Meeting mannkindcorp.com ↗
The Afrezza with Basal Combination (ABC) Study demonstrated similar glucose control between the three treatment groups; data to be presented and published in 2023 |
| 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. |
| 2022-06-06 | Eli Lilly and Company | Results New analyses of Mounjaro™ (tirzepatide) injection for the treatment of adults with type 2 diabetes presented at the American Diabetes Association's® 82nd Scientific Sessions® lilly.com ↗
Exploratory analysis showed that Mounjaro achieved A1C and weight targets in less time than injectable semaglutide 1 mg or titrated 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%). |
| 2021-09-30 | Eli Lilly and Company | Results Lilly's tirzepatide led to greater time in range compared to insulin degludec in adults with type 2 diabetes in SURPASS-3 CGM sub-study lilly.com ↗
All three tirzepatide doses led to more time in tight target range (71-140 mg/dL), improved glycemic variability and numerically less time in hypoglycemia compared to titrated insulin degludec |
| 2021-09-30 | Eli Lilly and Company | Results Lilly's tirzepatide led to greater improvements in liver fat content compared to insulin degludec in adults with type 2 diabetes in SURPASS-3 MRI sub-study lilly.com ↗
As evaluated by MRI scans, the sub-study showed all three doses of tirzepatide (5 mg, 10 mg, 15 mg) led to greater reductions in liver fat content compared to insulin degludec and reductions in volume of visceral adipose tissue and abdominal subcutaneous adipose tissue compared to increases in volume of both measurements with insulin degludec at 52 weeks. |
| 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 ↗ |
| 2016-11-10 | Novo Nordisk A/S | Regulatory Novo Nordisk submits application in the EU for including data from the two SWITCH trials in 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 from the two SWITCH phase 3b trials in the label for Tresiba®. |
| 2016-11-10 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender ansøgning i EU 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 type II-variationsansøgning til Det Europæiske Lægemiddelagentur (EMA) 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 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. |
| 2012-10-19 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager positive udtalelser om Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) fra de europæiske registreringsmyndigheder novonordisk.com ↗
Novo Nordisk meddelte i dag, at Udvalget for Humanmedicinske Lægemidler (CHMP) under Det Europæiske Lægemiddelagentur har afgivet positive udtalelser om Tresiba® og Ryzodeg® |
| 2012-10-19 | Novo Nordisk A/S | Regulatory Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) receive positive opinions from the European regulatory authorities novonordisk.com ↗
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted positive opinions, recommending marketing authorisations, for Tresiba® and Ryzodeg® for the treatment of diabetes mellitus in adults. |
| 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. |
| 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 84 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 193 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Insulin Degludec | “The combination of insulin degludec (100 units/mL) and liraglutide (3.6 mg/mL), termed IDegLira, was approved in 2014 for the treatment of type 2 diabetes inadequately...” NCT04190160 ↗151“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 ↗ “The study aims to compare insulin glargine, a long-acting basal insulin with approximately 24-hour duration, and insulin degludec, an ultra-long-acting basal insulin with about...” NCT07599891 ↗ “There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300).” PMID 35802405 ↗ Jul 2022 “The participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1.” NCT07376200 ↗ “Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient.” NCT04974528 ↗ “Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D.” PMID 35467938 ↗ Jun 2022 “insulin degludec (5 to 15 U at bedtime)” NCT04027023 ↗ “Drug: insulin degludec” NCT00612040 ↗ |
| Known as | degludec | “ABBREVIATIONS: A1C = hemoglobin A1C; AE = adverse event; CI = confidence interval; Degludec = insulin degludec; EOT = end of trial; ETD = estimated treatment difference; FPG =...” PMID 30383495 ↗ Nov 201812“The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with...” NCT01068665 ↗ “INTRODUCTION: DUAL II Japan (NCT02911948) was a 26-week, phase 3a randomized, treat-to-target trial which compared the efficacy and safety of IDegLira with degludec in 210...” PMID 31760599 ↗ Nov 2019 “METHODS: This phase 3a, treat-to-target multicenter trial randomized participants (glycated hemoglobin [HbA1c] 53.0-85.8 mmol/mol; previous metformin ± another OAD) 2:1:1 to...” PMID 35762390 ↗ Jun 2022 “The aim of the current study was to assess the efficacy and safety of once-weekly efsitora compared with daily insulin degludec (degludec) in adults with type 2 diabetes using...” PMID 40562047 ↗ Jun 2025 “comparing the efficacy and safety of once-weekly insulin icodec (icodec) versus once-daily insulin degludec (degludec) in insulin-naive participants with type 2 diabetes (T2D).” PMID 40016570 ↗ Feb 2025 “This phase 3 study aimed to assess the efficacy and safety of efsitora compared with insulin degludec (degludec) in adults with type 1 diabetes.” PMID 39270686 ↗ Sep 2024 “The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia.” NCT01570751 ↗ “once-daily insulin degludec (degludec) in basal insulin-treated type 2 diabetes” PMID 37148899 ↗ May 2023 “once-daily insulin degludec (degludec) in adults with type 1 diabetes” PMID 40742780 ↗ Jul 2025 “insulin degludec 200 units/mL (degludec)” PMID 32306247 ↗ Apr 2020 |
| Known as | Degludec insulin | “Drug: Degludec insulin” NCT07599891 ↗1“Drug: Degludec insulin” NCT07376200 ↗ |
| Known as | IDeg | “The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with...” NCT01068665 ↗38“The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes...” NCT01068678 ↗ “The purpose of the present study was to provide clinical data on the efficacy and safety of insulin degludec (IDeg) 200 U/mL compared with IDeg 100 U/mL in patients with type 2...” PMID 24518180 ↗ Aug 2014 “The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum...” NCT01664247 ↗ “This trial assessed the efficacy and safety of the possibility of varying the daily injection time of once-daily, long-acting basal insulin degludec (IDeg) in Japanese patients...” PMID 27182031 ↗ Apr 2016 “Insulin degludec (IDeg) is a new-generation, ultra-long-acting basal insulin that forms soluble multihexamers upon subcutaneous injection, resulting in a depot from which IDeg...” PMID 22726241 ↗ Jul 2012 “This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either...” NCT01704417 ↗ “The objective of this trial was to confirm the efficacy and compare the safety of insulin degludec (IDeg) with insulin glargine (IGlar) in a multinational setting with two...” PMID 27098525 ↗ Jun 2016 “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 trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug...” NCT01193387 ↗ “Subjects completing 104 weeks (52-week main trial BEGIN ONCE-LONG + 52-week extension) on insulin degludec (IDeg) OD + metformin with HbA1c ≥ 7.0% (≥53 mmol/mol) were...” PMID 24443830 ↗ Feb 2014 |
| Known as | IDeg-100 | “OBJECTIVE: To compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial.” PMID 30104294 ↗ Aug 20182“To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available” PMID 32100192 ↗ Feb 2020 “There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300).” PMID 35802405 ↗ Jul 2022 |
| Known as | insulin 454 | “The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at...” NCT01868529 ↗8“insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.” NCT01865292 ↗ “The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.” NCT01154881 ↗ “The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered” NCT01006057 ↗ “insulin degludec (insulin 454), an explorative formulation” NCT01865279 ↗ “two insulin degludec (insulin 454) preparations” NCT01868555 ↗ “insulin degludec (insulin 454)” NCT01865331 ↗ “insulin degludec (insulin 454)” NCT01868568 ↗ “insulin degludec (insulin 454)” NCT01865305 ↗ |
| Known as | insulin degludec/insulin aspart 15 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01773798 ↗ |
| Known as | insulin degludec/insulin aspart 30 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01868555 ↗ |
| Known as | insulin degludec/insulin aspart 40 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01865305 ↗ |
| Known as | insulin degludec/insulin aspart 45 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01868555 ↗ |
| Known as | insulin degludec/insulin aspart 50 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01865305 ↗ |
| Known as | NN1250 | “The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with...” NCT01068665 ↗26“The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes...” NCT01068678 ↗ “This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin...” NCT00611884 ↗ “The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese...” NCT01467414 ↗ “This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug...” NCT01193387 ↗ “This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with...” NCT01114542 ↗ “The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.” NCT01076634 ↗ “The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.” NCT01002768 ↗ “NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.” NCT01173926 ↗ “The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.” NCT01154881 ↗ “The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.” NCT01151072 ↗ |
| Known as | RD15003 | “Insulin degludec injection, RD15003” NCT05576298 ↗ |
| Known as | SIBA | “This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin...” NCT00611884 ↗1“to insulin degludec (NN1250, SIBA) on a basal-bolus regimen” NCT00841087 ↗ |
| Known as | Tresiba | “Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week.” NCT06288412 ↗7“Insulin degludec injection（Tresiba®）subcutaneous administration once daily for 26 weeks” NCT04955834 ↗ “Basal insulin (NPH, Lantus, Levimir, Toujeo or Tresiba)” NCT02846233 ↗ “Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra” NCT04965051 ↗ “Insulin Degludec 100 UNT/ML [Tresiba]” NCT03244241 ↗ “Insulin Degludec Injection (Tresiba®)” NCT07527078 ↗ “Insulin degludec, Tresiba” NCT05576298 ↗ |
| Modality | Protein / enzyme biologic | “Insulin degludec (IDeg) is a basal insulin that forms soluble multihexamers after subcutaneous injection, resulting in an ultra-long action profile.” PMID 21270174 ↗ Jan 2011 |
| Route | Subcutaneous | “Insulin degludec is a new basal insulin that forms soluble multihexamer assemblies after subcutaneous injection, resulting in an ultra-long action profile.” PMID 21396703 ↗ Mar 2011 |