Drugs / insulin degludec/insulin aspart
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Ryzodeg | — | 2015-04-07 | “FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart)” novonordisk.com ↗ “FDA has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart)” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | Ryzodeg | — | 2013-02-08 | “Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin...” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01009580 | Nov 2009 → Aug 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 NCT01009580 ↗ |
| Known as | IDegAsp | “OBJECTIVE: Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection.” PMID 24812432 ↗ May 2014 |
| Modality | Protein / enzyme biologic | “a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection” PMID 24812432 ↗ May 2014 |
| Route | Subcutaneous | “Injected s.c. (under the skin) with the breakfast meal and main evening meal.” NCT01009580 ↗ |