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 | “accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart)” novonordisk.com ↗ “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 | “modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg®” novonordisk.com ↗ “received a 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 2 | NCT00842361 | Jan → Jun 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
Press releases naming this drug 16 releases
Evidence & citations 6 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 NCT00842361 ↗ |
| Known as | IDegAsp | “Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%).” PMID 27560769 ↗ Oct 2016 |
| Known as | NN5401 | “This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin...” NCT00842361 ↗ |
| Known as | SIAC | “This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin...” NCT00842361 ↗ |
| Modality | Protein / enzyme biologic | “The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.” NCT00842361 ↗ |
| Route | Subcutaneous | “injected subcutaneously immediately before breakfast and dinner” NCT00842361 ↗ |