Semaglutide Demonstrated Superior Improvements in Glycaemic Control vs Sitagliptin (SUSTAIN 2) and Exenatide ER (SUSTAIN 3) in Two Clinical Trials in Adults With Type 2 Diabetes

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Abstracts 185-OR and 187-OR

Findings from two phase 3a clinical trials for semaglutide, an
investigational glucagon-like peptide-1 (GLP-1) analogue, were
presented today at the American Diabetes Association 76th Scientific
Sessions.[1],[2] In the SUSTAIN 2 trial, 0.5 mg and 1.0 mg
semaglutide administered once-weekly significantly improved glycaemic
control compared to sitagliptin (100 mg), a dipeptidyl peptidase-4
(DPP-4) inhibitor, in adults with type 2 diabetes.[1] In the SUSTAIN
3 trial, 1.0 mg semaglutide administered once-weekly significantly
improved glycaemic control compared to 2.0 mg exenatide
extended-release (ER), a GLP-1 receptor agonist, in adults with type
2 diabetes.[2]

The SUSTAIN 2 trial showed that from a mean baseline HbA1c of
8.1%, adults with type 2 diabetes treated with 0.5 mg and 1.0 mg
semaglutide achieved superior HbA1c reductions of 1.3% and 1.6%,
respectively, vs 0.5% with 100 mg sitagliptin at 56 weeks (both
p<0.0001), as add-on to metformin and/or thiazolidinediones.[1]

In the 56-week SUSTAIN 3 trial, adults with type 2 diabetes and a
mean baseline HbA1c of 8.3% achieved a superior HbA1c reduction of
1.5% when treated with 1.0 mg semaglutide vs 0.9% with 2.0 mg
exenatide ER (p<0.0001), as add-on to one or two oral antidiabetics
(metformin, sulfonylurea or thiazolidinediones).[2]

"Many people with type 2 diabetes struggle to reach individualised
treatment goals," said Bo Ahrén, Professor of Clinical Metabolic
Research at the Department of Clinical Sciences, Lund University,
Sweden. "The superior glucose reductions achieved with once-weekly
semaglutide vs sitagliptin in SUSTAIN 2 are encouraging as new
treatment options are needed to address these treatment goal
challenges."

More adults with type 2 diabetes achieved the HbA1c target of <7%
when treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in
SUSTAIN 2 (69% and 78% vs 36%)[1] and with 1.0 mg semaglutide vs
exenatide ER in SUSTAIN 3 (67% vs 40%).[2]

In addition, from a mean baseline body weight of 89.5 kg, adults
with type 2 diabetes achieved significantly greater reductions in
mean body weight when treated with 0.5 mg and 1.0 mg semaglutide vs
sitagliptin in SUSTAIN 2 (4.3 kg and 6.1 kg vs 1.9 kg; both
p<0.0001).[1] Similarly, from a mean baseline body weight of 95.8 kg,
adults with type 2 diabetes achieved significantly greater reductions
in mean body weight when treated with 1.0 mg semaglutide vs exenatide
ER in SUSTAIN 3 (5.6 kg vs 1.9 kg; p<0.0001).[2]

"The superior and sustained glycaemic control and weight loss
demonstrated in SUSTAIN 2 and 3 add to the growing clinical evidence
for our next-generation GLP-1 analogue, once-weekly semaglutide,"
said Mads Krogsgaard Thomsen, executive vice president and chief
science officer of Novo Nordisk. "We are excited about these results
and look forward to further data from the comprehensive SUSTAIN
clinical trial programme being presented later this year."

In SUSTAIN 2, the most common adverse events observed for adults
treated with 0.5 mg and 1.0 mg semaglutide and sitagliptin were
gastrointestinal (43.5% and 39.9% vs 23.6%). Comparable rates of
serious adverse events were observed for all treatment groups (7.3%
and 7.3% vs 7.1%). The proportions of adults discontinuing 0.5 mg,
1.0 mg or 100 mg sitagliptin due to adverse events were 8.1% and 9.5%
vs 2.9%, respectively.[1]

Similarly, in SUSTAIN 3, the most common adverse events observed
for adults treated with 1.0 mg semaglutide and exenatide ER were also
gastrointestinal (41.8% and 33.3%). Fewer adults reported injection
site reactions with 1.0 mg semaglutide (1.2%) compared with exenatide
ER (22.0%). The rates of serious adverse events observed for adults
treated with 1.0 mg semaglutide compared with exenatide ER were 9.4%
and 5.9%, respectively. The proportions of adults discontinuing due
to adverse events were 9.4% and 7.2%.[2]

About semaglutide

Semaglutide is an investigational 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.[3] Semaglutide administered
subcutaneously once-weekly is in phase 3 development for the
treatment of adults with type 2 diabetes.

About SUSTAIN 2

SUSTAIN 2 is a randomised, double-blind, double-dummy,
multicentre, multinational 56-week trial investigating the safety and
efficacy of semaglutide, administered once-weekly, vs sitagliptin, a
once-daily DPP-4 inhibitor, in 1,231 adults with type 2 diabetes,
where both drugs were added on to metformin and/or
thiazolidinediones. The primary endpoint was change in HbA1c from
baseline after 56 weeks of treatment. Secondary endpoints included
change in body weight from baseline after 56 weeks of treatment. The
trial was conducted in Argentina, Bulgaria, Czech Republic, Hong
Kong, Hungary, India, Japan, Mexico, Norway, Portugal, Romania,
Russia, South Africa, Spain, Sweden, Thailand, Turkey and Ukraine.

About SUSTAIN 3

SUSTAIN 3 is a randomised, open-label, multicentre, multinational
56-week trial investigating the safety and efficacy of semaglutide,
administered once-weekly, vs 2.0 mg exenatide extended release (ER)
once-weekly as add-on to one or two oral antidiabetic treatments in
813 adults with type 2 diabetes. The primary endpoint was change in
HbA1c from baseline after 56 weeks of treatment. Secondary endpoints
included change in body weight from baseline after 56 weeks of
treatment. The trial was conducted in Argentina, Croatia, Finland,
France, Germany, Greece, Italy, the Netherlands, Puerto Rico, Serbia,
Switzerland, 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 41,600 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
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

Melanie
Raouzeos

+45-3075-3479

mrz@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

References

1. Ahrén B, Comas LM, Kumar H, et al. Efficacy and safety of
once-weekly semaglutide vs sitagliptin as add-on to metformin and/or
thiazolidinediones after 56 weeks in subjects with type 2 diabetes
(SUSTAIN 2). Abstract number 185-OR. American Diabetes Association
76th Scientific Session, New Orleans, US; 10-14 June 2016.

2. Ahmann A, Capehorn M, Charpentier G, et al. Efficacy and safety
of once-weekly semaglutide vs exenatide ER after 56 weeks in subjects
with type 2 diabetes (SUSTAIN 3). Abstract number 187-OR. American
Diabetes Association 76th Scientific Session, New Orleans, US; 10-14
June 2016.

3. 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.

ots Originaltext: Novo Nordisk A/S
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