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2016-01-29

Novo Nordisk A/S: Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine in blinded phase 3b trial in people with type 2 diabet

Bagsværd, Denmark, 29 January 2016 -
Novo Nordisk today announced the headline results from SWITCH 2, the first of
two 2x32-weeks randomised, double-blind, cross-over, treat-to-target trials,
comparing the safety and efficacy of Tresiba®(insulin degludec) and insulin
glargine. The overall purpose of the trial was to compare the hypoglycaemia
occurrence in people with type 2 diabetes treated with Tresiba®or insulin
glargine.

In the trial, 721 people with type 2 diabetes were randomised to cross-over
treatment with Tresiba®and insulin glargine in combination with metformin.
The timing of the daily injections of both Tresiba®and insulin glargine was
randomised equally to take place either in the morning or evening. The
primary end-point of the trial was the number of treatment emergent severe or
blood glucose confirmed symptomatic hypoglycaemia episodes during the
maintenance period (ie after 16 weeks of treatment) in each treatment period.

From a mean baseline of 7.6%, the trial showed non-inferiority in
HbA1creduction of Tresiba®compared to insulin glargine, thus fulfilling the
requirements for objectively comparing hypoglycaemia rates between the two
treatments. Likewise, the end-of-trial insulin doses were similar at the end
of treatment in the two treatment periods.

The observed rate of severe or blood glucose confirmed symptomatic
hypoglycemia was 186 events per 100 patient years exposed to Tresiba®and 265
events per 100 patient years exposed to insulin glargine during the
maintenance period. This reduction was statistically significant, and the
trial thus met its primary endpoint by demonstrating a reduction of 30% when
people were treated with Tresiba®compared to insulin glargine.

The observed rate of severe or blood glucose symptomatic nocturnal confirmed
hypoglycaemia in the maintenance period was 55 events per 100 patient years
exposed to Tresiba®and 94 events per 100 patient years exposed to insulin
glargine, corresponding to a 42% reduction with Tresiba®compared to insulin
glargine and showing statistical significance on this confirmatory secondary
end-point.

The confirmatory secondary endpoint of proportions of subjects experiencing
severe hypoglycaemia during the maintenance period did not reach statistical
significance. However, the supportive end-point, rate of severe
hypoglycaemia, showed a 46% reduction with Tresiba®in the maintenance period
and a statistical significant reduction of 51% with Tresiba®in the full
treatment period.

In the trial, Tresiba®appeared to have a safe and well-tolerated profile.
Adverse events were comparable between the two treatment arms. The most
common adverse events were nasopharyngitis and upper respiratory tract
infections.

"We are excited about these trial results, which in a blinded setting confirm
the significant reduction in the risk of hypoglycaemia for Tresiba®compared
to insulin glargine" says Mads Krogsgaard Thomsen, executive vice president
and chief science officer of Novo Nordisk. "We look forward to reporting the
outcome of the SWITCH 1 trial in people with type 1 diabetes and to
evaluating the results from both trials".

Novo Nordisk expects to announce headline results of SWITCH 1 later in the
first quarter of 2016.

About SWITCH 1 and 2

The two 2x32-weeks randomised, double-blind, cross-over, treat-to-target
trials were initiated in January 2014 with purpose of comparing the safety
and efficacy of Tresiba®and insulin glargine. The overall purpose of the
trials is to document the hypoglycaemia profile in type 1 diabetes and type 2
diabetes respectively, compared to insulin glargine. In SWITCH 1, 501 people
with type 1 diabetes were randomised to crossover treatment with Tresiba®and
insulin glargine in combination with insulin aspart. In SWITCH 2, 721 people
with type 2 diabetes were randomised to crossover treatment with Tresiba®and
insulin glargine in combination with oral antidiabetics.

For further information

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| Media: |
| Mike Rulis +45 3079 3573 mike@novonordisk.com |
| Ken Inchausti (US) +1 609 514 8316 kiau@novonordisk.com |
| Investors: |
| Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com |
| Daniel Bohsen +45 3079 6376 dabo@novonordisk.com |
| Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com |
| Kasper Veje +45 3079 8519 kpvj@novonordisk.com |
| Company announcement No 6 / 2016 |
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Company announcement No 6 / 2016
http://hugin.info/2013/R/1982283/726367.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
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

HUG#1982283

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