Drugs / insulin degludec/insulin aspart
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® | diabetes mellitus | 2015-04-07 | “de amerikanske sundhedsmyndigheder (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® | diabetes mellitus | 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®” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00993096 | Sep → Dec 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2008-09-26 | Novo Nordisk A/S | Results Novo Nordisk provides update on corporate strategy at its Capital Markets Day novonordisk.com ↗
Headline data from the study showed that patients who switched from exenatide to liraglutide experienced the following benefits which were all statistically significant: |
All press releases naming this drug 17 releases
Evidence & citations 5 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 NCT00993096 ↗ |
| Known as | IDegAsp | “insulin degludec/insulin aspart (IDegAsp), a novel, soluble co-formulation” PMID 25772444 ↗ May 2015 |
| Known as | NN5401 | “NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses” NCT00993096 ↗ |
| Modality | Protein / enzyme biologic | “a novel, soluble co-formulation of the ultra-long-acting basal insulin, insulin degludec (IDeg), with the rapid-acting prandial insulin (IAsp)” PMID 25772444 ↗ May 2015 |
| Route | Subcutaneous | “injected subcutaneously (under the skin)” NCT00993096 ↗ |