Drugs / Insulin degludec/liraglutide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | type 2 diabetes mellitus | 2013-05-31 | “Novo Nordisk today announced the submission to the European Medicines Agency of the marketing authorisation application for the approval of IDegLira” novonordisk.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | — | “IDegLira was submitted to the FDA in September 2015 under the US FDA's Prescription Drug User Fee Act V (PDUFA V) regulation.” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03172494 | May 2017 → Jun 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
Press releases naming this drug 14 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/liraglutide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03172494 ↗ |
| Known as | IDegLira | “BACKGROUND: DUAL I China, one of the DUAL trials, assessed efficacy/safety of insulin degludec/liraglutide (IDegLira) in Chinese adults with type 2 diabetes (T2D) not...” PMID 35762390 ↗ Jun 2022 |
| Route | Subcutaneous | “Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.” NCT03172494 ↗ |