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	[phone]	[e-mail]
Ken Inchausti (US)	[phone]	[e-mail]
Investors:
Peter Hugreffe Ankersen	[phone]	[e-mail]
Hanna Ögren	[phone]	[e-mail]
Anders Mikkelsen	[phone]	[e-mail]
Kasper Veje (US)	[phone]	[e-mail]

Company announcement No 21 / 2017

PR170324_Tresiba_CHMP_recommendation_UK

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Source: Novo Nordisk A/S via Globenewswire