Drugs / insulin degludec/insulin aspart
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01513590 | Jan → Nov 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2015-04-07 | Novo Nordisk A/S | Regulatory US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗
Novo Nordisk today announced that 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 Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes in adults. |
| 2012-12-25 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗
Novo Nordisk meddelte i dag, at det japanske ministerium for sundhed, arbejde og velfærd har godkendt Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes. |
| 2012-10-25 | Novo Nordisk A/S | Regulatory FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published information pertaining to the focus of the Advisory Committee meeting scheduled for 8 November 2012 to discuss the New Drug Applications for insulin degludec and insulin degludec/insulin aspart. |
All press releases naming this drug 19 releases
Evidence & citations 3 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 NCT01513590 ↗ |
| Known as | IDegAsp | “Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation” PMID 26612062 ↗ Mar 2016 |
| Route | Subcutaneous | “Administered s.c. (under the skin) twice daily.” NCT01513590 ↗ |