drugset
Drugs / insulin degludec/insulin aspart
last change Apr 2013 re-read 9 days ago

insulin degludec/insulin aspart

also known as IDegAsp · NN5401
Developed for
type 2 diabetes mellitus
Investigated by
Novo Nordisk A/S

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Rejected (CRL) US (FDA) Ryzodeg® diabetes mellitus 2013-02-08

“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

today NCT01272193 · Ph 3
20112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT01272193 Jan → Sep 2011 type 2 diabetes mellitus Novo Nordisk A/S Completed Met primary

Press releases naming this drug 16 releases

DateIssuerRelease
2013-01-21 Novo Nordisk A/S Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
2012-12-25 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗
2012-12-25 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗
2012-12-03 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗
2012-12-03 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) passerer evaluering i japansk medicinkomite novonordisk.com ↗
2012-11-08 Novo Nordisk A/S Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗
2012-11-06 Novo Nordisk A/S FDA offentliggør briefingmateriale forud for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-11-06 Novo Nordisk A/S FDA posts briefing materials prior to Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-10-25 Novo Nordisk A/S FDA offentliggør fokus for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-10-25 Novo Nordisk A/S FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-10-19 Novo Nordisk A/S Novo Nordisk modtager positive udtalelser om Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) fra de europæiske registreringsmyndigheder novonordisk.com ↗
2012-10-19 Novo Nordisk A/S Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) receive positive opinions from the European regulatory authorities novonordisk.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as insulin degludec/insulin aspart ClinicalTrials.gov intervention name — accepted as the source's own label NCT01272193 ↗
Known as IDegAsp “This phase 3, 26-week, open-label, treat-to-target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in” PMID 23557077 ↗ Apr 2013
Known as NN5401 “The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan.” NCT01272193 ↗
Route Subcutaneous “Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).” NCT01272193 ↗