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2015-09-25

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

Bagsværd, Denmark, 25 September 2015 -
Novo Nordisk today announced the headline results from the second phase 3a
trial for semaglutide, SUSTAIN3. Semaglutide is a new GLP-1 analogue
administered subcutaneously once weekly. The trial investigated the efficacy
and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide once-weekly
after 56 weeks of treatment added on to 1-2 oral antidiabetic drugs in 813
people with type 2 diabetes.

The trial achieved its objective by demonstrating that from a mean baseline
HbA1cof 8.4%, people treated with 1.0 mg semaglutide achieved a statistically
significant and superior improvement in HbA1cof 1.5% compared to the
improvement in HbA1cof 0.9% with 2.0 mg exenatide once-weekly.

66% of the people treated with 1.0 mg semaglutide achieved the American
Diabetes Association (ADA) and the European Association for the Study of
Diabetes (EASD) treatment target of HbA1cbelow 7% compared with 40% of the
people treated with 2.0 mg exenatide once-weekly.

Furthermore, from a mean baseline body weight of 96 kg, people treated with
1.0 mg semaglutide experienced a statistically significant and superior
weight loss of 5.6 kg compared with a weight loss of 1.8 kg for people
treated with 2.0 mg exenatide once-weekly.

In the trial, semaglutide appeared to have a safe and well-tolerated profile.
The most common adverse event was nausea which diminished over time. Nausea
was reported by 22% of people treated with 1.0 mg semaglutide once-weekly
compared with 11% of people treated with 2.0 mg exenatide once-weekly. The
discontinuation rate due to all adverse events for 1.0 mg semaglutide was
9.4% compared to 7.2% for 2.0 mg exenatide.

"We are excited about these trial results, which show that 1.0 mg semaglutide
injected once weekly provided better glycaemic control and greater weight
loss than 2.0 mg exenatide once-weekly," says Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk. "These
results support that semaglutide has the potential to become the most
efficacious GLP-1 product for people with type 2 diabetes. We look forward to
further results from the SUSTAIN clinical development programme."

Novo Nordisk expects to announce headline results of the four remaining
SUSTAIN trials within the next coming quarters.

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 once
weekly is in development for the treatment of type 2 diabetes.

About the SUSTAIN clinical programme

The SUSTAIN programme is a phase 3 clinical programme comprising six global
trials of semaglutide administered 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 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: |
| 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 |
| Frank Daniel Mersebach (US) +1 609 235 8567 fdni@novonordisk.com |
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Company announcement No 57 / 2015

Read the announcement in PDF
http://hugin.info/2013/R/1954507/711318.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#1954507

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