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2016-02-23

Novo Nordisk A/S: Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine U100 in blinded phase 3b trial in people with type 1 d

Bagsværd, Denmark, 23 February 2016 -
Novo Nordisk today announced the headline results from SWITCH 1, the second of
two 2x32-weeks randomised, double-blind, cross-over, treat-to-target trials,
comparing the safety and efficacy of Tresiba®(insulin degludec) and
Lantus®(insulin glargine U100). The overall purpose of the trial was to
compare the hypoglycaemia occurrence in people with type 1 diabetes treated
with Tresiba®or insulin glargine.

In the trial, 501 people with type 1 diabetes were randomised to cross-over
treatment with Tresiba®and insulin glargine U100 in combination with insulin
aspart. 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 for 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 trial met the primary end-point by demonstrating non-inferiority in the
rate of severe or blood glucose confirmed symptomatic hypoglycemia of
Tresiba®compared to insulin glargine. The observed rate was 2,201 events per
100 patient years exposed to Tresiba®and 2,463 events per 100 patient years
exposed to insulin glargine during the maintenance period, corresponding to a
statistically significant reduction of 11%.

Similarly, non-inferiority was demonstrated for the rate of severe or blood
glucose confirmed symptomatic nocturnal hypoglycaemia in the maintenance
period. The observed rate of severe or blood glucose confirmed symptomatic
nocturnal hypoglycaemia was 277 events per 100 patient years exposed to
Tresiba®and 429 events per 100 patient years exposed to insulin glargine,
corresponding to a statistically significant 36% reduction with
Tresiba®compared to insulin glargine.

Finally, superiority was demonstrated for the confirmatory secondary endpoint
of proportions of subjects experiencing severe hypoglycaemia during the
maintenance period. The proportion of patients experiencing severe
hypoglycaemia was 10% for Tresiba®and 17% for insulin glargine, corresponding
to a statistically significant reduction with Tresiba®compared to insulin
glargine. The rates of severe hypoglycaemia were 69 and 92 events per 100
patient years exposed, respectively, corresponding to a statistically
significant 35% reduction.

All of the above analyses showed similar results for the total 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, upper respiratory tract
infections and hypoglycaemia.

"We are very excited about these trial results, which document that
Tresiba®also in people with type 1 diabetes significantly reduces the risk of
hypoglycaemia compared to insulin glargine" says Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk. "We
expect to initiate filing of the data from the SWITCH trials with regulatory
authorities in Q3 2016 with the aim of updating the label for Tresiba®".

Conference call

On 24 February 2016 at 8.30 am CET, corresponding to 2.30 am EST, a conference
call for investors will be held. Investors will be able to listen in via a
link on the investor section of novonordisk.com.

About SWITCH 1 and 2

The two 2x32-weeks randomised, double-blind, cross-over, treat-to-target
trials were initiated in January 2014 with the purpose of comparing the
safety and efficacy of Tresiba®and Lantus®(insulin glargine U100). 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 U100. In SWITCH 1, 501 people with type 1 diabetes were randomised
to cross-over treatment with Tresiba®and insulin glargine U100 in combination
with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were
randomised to cross-over treatment with Tresiba®and insulin glargine U100 in
combination with oral antidiabetics. The results from SWITCH 2 were reported
on 29 January 2016.

Lantus®is a registered trademark of Sanofi.

For further information

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| Media: |
| Mike Rulis +45 3079 3573 mike@novonordisk.com |
| Ken Inchausti (US) +1 609 786 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 |
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Company announcement No 17 / 2016

Company announcement No 17 / 2016
http://hugin.info/2013/R/1988404/730062.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#1988404

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