drugset

Drugs / insulin degludec/insulin aspart

Follow last change Feb 2013 re-read 3 minutes ago

insulin degludec/insulin aspart

also known as NN5401

Developed for: type 2 diabetes mellitus
Investigated by: Novo Nordisk A/S

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Rejected (CRL)	US (FDA)	Ryzodeg	—	2013-02-08	“on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA)” novonordisk.com ↗

Trials 1

today NCT01045447 · Ph 3

201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT01045447	Jan → Oct 2010	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	Met primary

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

Date	Issuer	Release
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 ↗
2012-07-18	Novo Nordisk A/S	Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-07-18	Novo Nordisk A/S	Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-06-08	Novo Nordisk A/S	Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗
2012-06-08	Novo Nordisk A/S	Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗
2008-09-26	Novo Nordisk A/S	Novo Nordisk provides update on corporate strategy at its Capital Markets Day novonordisk.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	insulin degludec/insulin aspart	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01045447 ↗
Known as	NN5401	“The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with...” NCT01045447 ↗
Route	Subcutaneous	“injected subcutaneously (under the skin) once daily with main meal” NCT01045447 ↗