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2015-08-24

Novo Nordisk A/S: Novo Nordisk completes second and final phase 3a trial with liraglutide as adjunct therapy to insulin for people with type 1 diabetes (NN9211

Bagsværd, Denmark, 24 August 2015
- Novo Nordisk today announced headline results from the second and final
phase 3a trial with liraglutide as adjunct therapy to insulin for people with
type 1 diabetes. ADJUNCT ONE(TM) is a randomised, double-blind,
placebo-controlled trial investigating efficacy and safety of daily doses of
0.6 mg, 1.2 mg and 1.8 mg liraglutide compared with placebo as adjunct to
insulin treatment. 1,398 people with type 1 diabetes were treated for 52
weeks.

From a mean baseline HbA1cof around 8.2%, people treated with 1.2 mg and 1.8
mg liraglutide as adjunct to insulin therapy achieved the primary objective
of non-inferiority in HbA1cand showed a greater improvement in HbA1cof around
0.5% compared with 0.3% for people treated with placebo. The primary
objective of HbA1cnon-inferiority was not confirmed for the 0.6 mg dose.

Furthermore, from a mean baseline weight of around 86 kg, people treated with
1.2 mg and 1.8 mg liraglutide as adjunct to insulin therapy achieved a
statistically significantly greater weight loss between 3 kg and 4 kg whereas
people treated with placebo experienced a weight gain of around 1 kg.

In the trial, the most common adverse events were related to the
gastrointestinal system, primarily transient nausea and vomiting. The rate of
severe hypoglycaemia appeared numerically, but not statistically
significantly lower for all doses of liraglutide as adjunct to insulin
therapy compared with placebo. A statistically significant higher rate of
confirmed symptomatic hypoglycaemia was observed among people treated with
liraglutide 1.2 mg and 1.8 mg compared with people treated with placebo. The
proportion of people with serious adverse events was similar in all treatment
groups.

Based on a risk/benefit assessment of the overall dataset from the two ADJUNCT
trials, Novo Nordisk does currently not intend to submit an application to
expand the label of Victoza®for use in type 1 diabetes. Novo Nordisk intends
to conduct thorough analyses to evaluate the clinical data and define
potential future clinical and regulatory initiatives.

"The results of the two ADJUNCT trials show that liraglutide as adjunct to
insulin therapy met the primary end-point of improving blood glucose control
for people with type 1 diabetes, however, unfortunately without the
hypoglycaemic benefit experienced in type 2 diabetes " said Mads Krogsgaard
Thomsen, executive vice president and chief science officer of Novo Nordisk.
"We are disappointed as we believed in the potential to provide people with
type 1 diabetes with a new treatment option, and we will continue to invest
in new treatment options for this group of people."

About liraglutideLiraglutide is a once-daily human analogue of the naturally occurring hormone
Glucagon-Like Peptide-1 (GLP-1). The compound is approved for the treatment
of type 2 diabetes, and is currently in phase 3 development for the treatment
of type 1 diabetes as adjunct to insulin therapy. Liraglutide works by
stimulating the release of insulin only when glucose levels become too high,
supressing the glucagon production by the liver and by inhibiting appetite.
In contrast to most other antidiabetic treatments, liraglutide also leads to
weight loss instead of weight increase.

About the ADJUNCT clinical programmeThe ADJUNCT programme is a phase 3 clinical programme comprising two global
trials of liraglutide as adjunct to insulin therapy encompassing more than
2,000 people with type 1 diabetes.

ADJUNCT ONE(TM) (1,398 people randomised) - a 52-week, double-blind,
placebo-controlled treat-to-target trial investigating liraglutide as adjunct
to insulin therapy.

ADJUNCT TWO(TM) (835 people randomised) - a 26-week, double-blind,
insulin-capped, placebo-controlled trial investigating the additional glucose
control of liraglutide as adjunct to insulin therapy. The results were
announced on 6 August 2015.

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 |
| Frank Daniel Mersebach (US) +1 609 235 8567 fdni@novonordisk.com |
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Company announcement No 51 / 2015

Company announcement No 51 / 2015
http://hugin.info/2013/R/1947182/707001.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#1947182

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