CHMP provides positive opinion for EU label update for Novo Nordisk's Tresiba® based on data from SWITCH trials - Seite 2
About SWITCH 1 and 2
The two phase 3b, 2x32-week randomised, double-blind, crossover, treat-to-target trials were initiated to investigate the hypoglycaemia profile of Tresiba® compared to insulin glargine U100 in people with type 1 and type 2 diabetes, respectively. The primary endpoint was the number of severe or
blood glucose confirmed symptomatic hypoglycaemic episodes observed in participants. The two secondary endpoints included: the number of severe or blood glucose confirmed nocturnal episodes
experienced in participants; and the proportion of people with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with
Tresiba® and insulin glargine U100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were
randomised to crossover treatment with Tresiba® and insulin glargine U100 in combination with oral antidiabetic
drugs.
Further information
Media: | ||
Katrine Sperling | +45 4442 6718 | krsp@novonordisk.com |
Ken Inchausti (US) | +1 609 786 8316 | kiau@novonordisk.com |
Investors: | ||
Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com |
Hanna Ögren | +45 3079 8519 | haoe@novonordisk.com |
Anders Mikkelsen | +45 3079 4461 | armk@novonordisk.com |
Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com |
Lesen Sie auch
Company announcement No 21 / 2017
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via Globenewswire