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2016-02-23

Novo Nordisk A/S: Novo Nordisk successfully completes fifth phase 3a trial with semaglutide in people with type 2 diabetes

Bagsværd, Denmark, 23 February 2016 -
Novo Nordisk today announced the headline results from the fifth phase 3a
trial for semaglutide, SUSTAIN5. Semaglutide is a new GLP-1 analogue, which
in the SUSTAIN trials is administered subcutaneously once weekly. The
double-blinded trial investigated the efficacy and safety of 0.5 mg and 1.0
mg semaglutide compared with placebo as add-on to basal insulin alone or
basal insulin in combination with metformin, after 30 weeks of treatment in
397 people with type 2 diabetes.

The trial successfully achieved its objective by demonstrating that people
treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically
significant and superior improvement in HbA1cof 1.4% and 1.8% respectively,
from a mean baseline HbA1cof 8.4%, compared with an improvement in HbA1cof
0.1% with placebo. Additionally, the end of trial insulin dose for people
treated with 0.5 mg and 1.0 mg semaglutide was reduced by 10% and 15%
respectively, compared with 3% for the placebo group.

61% of the people treated with 0.5 mg semaglutide and 79% of the people
treated with 1.0 mg semaglutide achieved the treatment target of HbA1cbelow
7% set by the American Diabetes Association (ADA) and the European
Association for the Study of Diabetes (EASD), compared with 11% of the people
treated with placebo.

From a mean baseline body weight of 92 kg, people treated with 0.5 mg and 1.0
mg semaglutide experienced a statistically significant and superior weight
loss of 3.7 kg and 6.4 kg respectively, compared with a weight loss of 1.4 kg
for people treated with placebo.

In the trial, semaglutide appeared to have a safe and well-tolerated profile.
The most common adverse event was nausea. Nausea was reported by 11% of the
people treated with 0.5 mg semaglutide and by 17% of the people treated with
1.0 mg semaglutide, compared with 5% of people treated with placebo. Severe
or blood glucose-confirmed symptomatic hypoglycaemia was experienced by 8%
and 11% of people treated with 0.5 mg or 1.0 mg once-weekly semaglutide
respectively, compared with 5% in the placebo group. The discontinuation rate
due to adverse events was 5% and 6% for people treated with 0.5 mg
semaglutide and 1.0 mg semaglutide respectively, compared to 1% for people
treated with placebo.

"We are excited about the results of SUSTAIN 5, showing superior efficacy in
glycaemic control and weight loss with semaglutide administered once-weekly
in patients inadequately controlled on basal insulin" says Mads Krogsgaard
Thomsen, executive vice president and chief science officer of Novo Nordisk.
"The results from the first five SUSTAIN trials support the potential for
broad usage of semaglutide in people with type 2 diabetes, as results have
been consistent when exploring people with both early onset as well as late
stage type 2 diabetes."

Novo Nordisk expects to announce headline results of the final SUSTAIN trial,
SUSTAIN 6 in the first half of 2016.

About semaglutide Semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue that can help
people with type 2 diabetes achieve substantial improvement of blood glucose
with a low risk of hypoglycaemia. In addition, semaglutide induces weight
loss by decreasing appetite and food intake. Semaglutide administered
subcutaneously once weekly is in phase 3 development for the treatment of
type 2 diabetes. Furthermore, semaglutide is being developed in an oral
tablet version for treatment of type 2 diabetes as well as once-daily
subcutaneous versions for treatment of type 2 diabetes and weight management.

About the SUSTAIN clinical programme

The SUSTAIN programme is a phase 3 clinical programme comprising six global
trials of semaglutide administered subcutaneously once weekly encompassing
more than 7,000 people with type 2 diabetes.

SUSTAIN 1 - a 30-week efficacy and safety trial of semaglutide versus placebo
in 388 drug-naïve people with type 2 diabetes.

SUSTAIN 2 - a 56-week efficacy and safety trial of semaglutide versus
sitagliptin once-daily as add-on to metformin and/or TZD in 1,231 people with
type 2 diabetes.

SUSTAIN 3 - a 56-week efficacy and safety trial of semaglutide versus 2.0 mg
exenatide once-weekly as add-on to 1-2 oral antidiabetic drugs in 813 people
with type 2 diabetes.

SUSTAIN 4 - a 30-week efficacy and safety trial of semaglutide versus insulin
glargine once-daily as add-on to metformin with or without sulfonylurea in
1,089 insulin-naïve people with type 2 diabetes.

SUSTAIN 5 - a 30-week efficacy and safety trial of semaglutide versus placebo
as add-on to basal insulin alone or basal insulin in combination with
metformin in 397 people with type 2 diabetes.

SUSTAIN 6 - a 2-year trial not yet reported to evaluate cardiovascular and
other long-term outcomes with semaglutide in 3,297 people with type 2
diabetes.

For further information

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| Media: |
| Katrine Sperling +45 3079 6718 krsp@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 18 / 2016

Company announcement No 18 / 2016
http://hugin.info/2013/R/1988465/730077.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#1988465

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