Ozempic® Consistently Reduced the Risk of Major Cardiovascular Events Across Type 2 Diabetes Populations at High CV Risk Regardless of Prior CV Events at Baseline

Munich (ots/PRNewswire) - Ozempic® (semaglutide) consistently
reduced the risk of the composite outcome of time to first occurrence
of non-fatal heart attack, non-fatal stroke or cardiovascular death
(collectively termed major adverse cardiovascular events, MACE) in
people with type 2 diabetes at high cardiovascular risk regardless of
previously having had a cardiovascular event at the start of the
trial.1 Findings from two post-hoc subgroup analyses of the SUSTAIN 6
trial and one post-hoc meta-analysis of MACE in the SUSTAIN 1-5
trials were presented today at the ESC Congress 2018, organised by
the European Society of Cardiology, in Munich, Germany.1

"Cardiovascular disease remains the leading cause of disability
and death in people with type 2 diabetes and there is an increasing
focus on reducing cardiovascular risk in the clinic," said Professor
Stephen Bain, School of Medicine, Swansea University, UK. "We have
seen from clinical trials that diabetes treatments confer variable
effects on cardiovascular outcomes and the results of these post-hoc
analyses provide further evidence of the consistent cardiovascular
risk reduction of Ozempic® in people with type 2 diabetes, with
varying profiles of cardiovascular risk at baseline."

The SUSTAIN 6 post-hoc analyses found that reduction in the risk
of MACE was consistent in people at high cardiovascular risk treated
with Ozempic® regardless of their cardiovascular risk profile at the
start of the trial, including whether or not they had a prior heart
attack or stroke, and whether they had cardiovascular risk factors or
established cardiovascular disease.1 SUSTAIN 6 was a pre-approval
cardiovascular outcomes trial in 3,297 people with type 2 diabetes
and established cardiovascular disease or with at least one
cardiovascular risk factor, compared to placebo, both in addition to
standard of care.2

The post-hoc pooled meta-analysis of the SUSTAIN 1-5 efficacy
trials, which included 4,807 people, trended towards a lower risk of
MACE in people taking Ozempic®. The comparators included in SUSTAIN
1-5 were placebo, sitagliptin, exenatide extended release and insulin
glargine U100. The overall incidence of MACE was low across the
SUSTAIN 1-5 trials and, due to the low number of events, this
reduction did not achieve statistical significance.1

About Ozempic®

Ozempic® (semaglutide) is a once-weekly analogue of human
glucagon-like peptide-1 (GLP-1) indicated for the treatment of adults
with insufficiently controlled type 2 diabetes as an adjunct to diet
and exercise to improve glycaemic control in adults with type 2
diabetes, as monotherapy when metformin is considered inappropriate
due to intolerance or contraindications, or in addition to other
medicinal products for the treatment of diabetes.3 Ozempic® was
approved by the U.S. Food and Drug Administration on 5 December,
2017, by Health Canada on 4 January, 2018, by the European Commission
on 9 February, 2018 and on 23 March, 2018 by the Japanese Ministry of
Health, Labour and Welfare.4-7

About the SUSTAIN clinical trial programme

The SUSTAIN global clinical development programme for Ozempic®
comprises eight phase 3a trials, encompassing more than 8,000 adults
with type 2 diabetes. The phase 3a programme involves a broad range
of people with type 2 diabetes, including some with high
cardiovascular risk profiles.

The primary analysis of the SUSTAIN 6 trial was published in The
New England Journal of Medicine.2 The primary outcome measure was a
composite outcome of major adverse cardiovascular events (MACE),
defined as non-fatal myocardial infarction, non-fatal stroke or
cardiovascular death. Ozempic®-treated patients had a significant 26%
lower risk of MACE vs those receiving placebo over 2 years (hazard
ratio 0.74; 95% confidence interval 0.58-0.95).2 SUSTAIN 6 was
designed to assess non-inferiority, i.e. demonstrate no increased
risk of major cardiovascular events vs placebo, when added to
standard of care. Testing for superiority was not part of the
pre-specified analysis.

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs
approximately 43,100 people in 79 countries and markets its products
in more than 170 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).

References

1. Bain S, Réa R, Warren ML, et al. Semaglutide consistently reduces
cardiovascular risk in patients with type 2 diabetes regardless of
baseline cardiovascular risk level: post hoc analyses of the
SUSTAIN trial programme. Abstract number P-2859. Presented at the
2018 Congress of the European Society of Cardiology, Munich,
Germany. 25-29 August.
2. Marso SP, Bain SC, Consoli A, et al. Semaglutide and
cardiovascular outcomes in patients with type 2 diabetes. N Engl J
Med. 2016;375:1834-1844.
3. EMA. Ozempic® (semaglutide) SmPC. Available at: http://www.ema.eur
opa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/huma
n/004174/WC500244163.pdf. Last accessed: July 2018.
4. Novo Nordisk. Ozempic® approved in the EU for the treatment of
type 2 diabetes. Available at:
https://www.novonordisk.com/bin/getPDF.2167679.pdf. Last accessed:
August 2018.
5. Novo Nordisk. Ozempic® (semaglutide) approved in the US. Available
at: https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk
-com/en_gb/home/media/news-details.2154210.html. Last accessed:
August 2018.
6. Novo Nordisk. Ozempic® approved in Canada for the treatment of
adults with type 2 diabetes. Available at: http://www.novonordisk.
ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Ozempic%20
press%20release_Eng_01.08.2018_FINAL.pdf Last accessed: August
2018.
7. Novo Nordisk. Ozempic® approved in Japan for the treatment of type
2 diabetes. Available at: https://www.novonordisk.com/content/Denm
ark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.h
tml. Last accessed: August 2018.

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
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Valdemar Borum Svarrer +45 3079 0301 jvls@novonordisk.com

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