Semaglutide Demonstrated Superior Improvements In Glycaemic Control Vs Placebo In Adults With Type 2 Diabetes

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Abstract #OR15-1

Findings from the first phase 3a clinical trial for semaglutide,
an investigational glucagon-like peptide-1 (GLP-1) analogue,
demonstrated that treatment with semaglutide administered
once-weekly, significantly improved glycaemic control compared to
placebo in adults with type 2 diabetes previously managed with diet
and exercise alone. Results from the SUSTAIN 1 trial were presented
today at the Endocrine Society's 98th Annual Meeting and Expo (ENDO
2016) in Boston, MA, US.[1]

The 30-week SUSTAIN 1 trial, evaluating the efficacy and safety of
semaglutide monotherapy vs placebo in 388 adults with type 2
diabetes,[1] showed that, from a mean baseline HbA1c of 8.1%, adults
treated with 0.5 mg and 1.0 mg semaglutide achieved significantly
greater HbA1c reductions of 1.5% and 1.6%, respectively, vs <0.1%
with placebo.

In addition, more adults treated with 0.5 mg and 1.0 mg
semaglutide achieved HbA1c targets compared with placebo: HbA1c <7%
(74% and 72% vs 25%) and <=6.5% (59% and 60% vs 13%). The trial also
demonstrated that adults treated with 0.5 mg and 1.0 mg semaglutide
achieved significantly greater reductions from baseline in mean body
weight of 3.7 kg/8.16 lb and 4.5 kg/9.92 lb, respectively, vs 1.0
kg/2.20 lb with placebo.[1]

"Achieving glycaemic control remains a significant challenge for
people with type 2 diabetes and their treating physicians," said
Christopher Sorli, SUSTAIN 1 investigator and Chair of the Department
of Diabetes, Endocrinology and Metabolism, Billings Clinic, US. "It
is encouraging that almost three out of four adults treated with
semaglutide in the SUSTAIN 1 trial achieved the HbA1c target of less
than seven percent."

Furthermore, adults treated with both doses of semaglutide
demonstrated significantly greater reductions from baseline in
fasting plasma glucose compared with placebo (2.5 mmol/L or 45.2
mg/dL and 2.3 mmol/L or 42.1 mg/dL, respectively, vs 0.6 mmol/L or
9.9 mg/dL).[1]

The most common adverse events observed for adults treated with
0.5 mg and 1.0 mg semaglutide and placebo were gastrointestinal,
which were mainly mild or moderate (nausea: 20.3% and 23.8% vs 7.8%;
vomiting: 3.9% and 6.9% vs 1.6%; diarrhoea: 12.5% and 10.8% vs 2.3%).
The rate of nausea diminished over time. Comparable rates of severe
adverse events were observed for adults treated with 0.5 mg and 1.0
mg semaglutide compared with placebo (5.5% and 5.4% vs 3.9%). The
proportion of adults discontinuing due to adverse events was low
across treatment groups (6.3% and 5.4% vs 2.3%).[1]

About semaglutide

Semaglutide is an analogue of native human glucagon-like peptide-1
(GLP-1) that stimulates insulin and suppresses glucagon secretion in
a glucose-dependent manner, as well as decreases appetite and food
intake.[2] Semaglutide administered subcutaneously once-weekly is in
phase 3 development for the treatment of type 2 diabetes.

About SUSTAIN 1

SUSTAIN 1 is a randomised, double-blind, placebo-controlled,
multicentre, multinational 30-week trial investigating the safety and
efficacy of semaglutide, administered once-weekly, versus placebo in
388 people with type 2 diabetes who had not received any blood
glucose lowering therapies 90 days prior to trial participation. The
trial was conducted in Canada, Italy, Japan, Mexico, Russia, South
Africa, UK and the US.

About the SUSTAIN clinical programme

SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type
2 Diabetes) is a clinical programme for semaglutide, administered
once-weekly, that comprises six phase 3a global clinical trials
encompassing more than 7,000 people with type 2 diabetes as well as
two Japanese trials encompassing around 1,000 people with type 2
diabetes.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat other serious chronic conditions: haemophilia, growth
disorders and obesity. Headquartered in Denmark, Novo Nordisk employs
approximately 41,000 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
novonordisk.com (http://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.youtube.com/novonordisk)

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7708

aajf@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

References

1. Sorli C, Harashima S, Tsoukas G, et al. SUSTAIN 1: efficacy and
safety of once-weekly semaglutide monotherapy versus placebo in
subjects with type 2 diabetes. Abstract number OR15-1. Endocrine
Society's 98th Annual Meeting and Expo (ENDO 2016), Boston, MA,
US; 1-4 April 2016.
2. Nauck MA, Petrie JR, Sesti G, et al. A phase 2, randomized,
dose-finding study of the novel once-weekly human GLP-1 analog,
semaglutide, compared with placebo and open-label liraglutide in
patients with type 2 diabetes. Diabetes Care. 2015; 39:231-241.

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