Drugs / insulin degludec/insulin aspart
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | Ryzodeg | diabetes mellitus, congenital autoimmune | 2013-02-08 | “den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin...” novonordisk.com ↗ “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...” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01059812 | Feb → Dec 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
Press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin degludec/insulin aspart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01059812 ↗ |
| Known as | IDegAsp | “This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in...” NCT01059812 ↗ |
| Modality | Protein / enzyme biologic | “IDegAsp is a soluble coformulation of the basal analog insulin degludec and the rapid-acting prandial insulin aspart in a single injection.” PMID 26612062 ↗ Mar 2016 |
| Route | Subcutaneous | “Injected subcutaneously twice daily.” NCT01059812 ↗ |