Oral semaglutide demonstrated cardiovascular safety in people with type 2 diabetes and established cardiovascular disease or high cardiovascular risk in PIONEER 6 trial

San Francisco (ots/PRNewswire) - Novo Nordisk today announced that
the PIONEER 6 trial achieved its primary endpoint by demonstrating
non-inferiority of major adverse cardiovascular events (MACE) with
oral semaglutide compared with placebo, both in addition to standard
of care. The primary endpoint was defined as the MACE composite
outcome of the first occurrence of cardiovascular death, non-fatal
myocardial infarction or non-fatal stroke and non-inferiority for
cardiovascular safety of oral semaglutide versus placebo was
confirmed with a hazard ratio (HR) of 0.79 (p<0.001) in favour of
oral semaglutide compared with placebo. The results are based on an
accumulation of 137 first major adverse cardiovascular events and a
median follow-up time of 16 months.

The main results from PIONEER 6 were presented today at the
American Diabetes Association (ADA) 79th Scientific Sessions and
simultaneously published in The New England Journal of Medicine
(NEJM)1,2. Oral semaglutide is an investigational glucagon-like
peptide-1 (GLP-1) analogue in a pill.

The MACE results were driven by the individual components of
cardiovascular death [15 (0.9%) events with oral semaglutide vs 30
(1.9%) events with placebo, HR 0.49, p=0.03] and non-fatal strokes
[12 (0.8%) events with oral semaglutide vs 16 (1.0%) events with
placebo, HR 0.74, non-significant]. The number of non-fatal
myocardial infarctions with oral semaglutide was not significantly
different than placebo [37 (2.3%) events with oral semaglutide vs 31
(1.9%) events with placebo, HR 1.18, non-significant]. Among the
secondary endpoints, the number of all-cause deaths was significantly
lower in people treated with oral semaglutide compared with placebo
[23 (1.4%) events vs 45 (2.8%) events, HR 0.51, p=0.008].

"Cardiovascular disease is the most common cause of disability and
death in people with type 2 diabetes," said Dr Mansoor Husain,
PIONEER 6 investigator and lead author for the NEJM publication of
PIONEER 6 and director of the Ted Rogers Centre for Heart Research
and Toronto General Hospital Research Institute, Canada. "The PIONEER
6 trial demonstrates that oral semaglutide does not increase the risk
of major adverse cardiovascular events while providing further
evidence for the overall cardiovascular profile of semaglutide."

The safety profile of oral semaglutide was consistent with that of
the GLP-1 receptor agonist class and similar to those seen with
subcutaneous semaglutide.

"The results of PIONEER 6 further strengthen the overall clinical
evidence for oral semaglutide, building upon the strong clinical data
reported throughout the PIONEER clinical trial programme," said Mads
Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk. "We are excited about the potential of oral
semaglutide to become the first and only oral GLP-1 treatment for
people with type 2 diabetes."

About PIONEER 6 and the PIONEER clinical trial programme

PIONEER 6 was an event-driven, pre-approval cardiovascular
outcomes trial for oral semaglutide. It was a randomised,
double-blinded, placebo-controlled trial evaluating the
cardiovascular safety of oral semaglutide vs placebo when added to
standard of care in 3,183 people with type 2 diabetes at high risk of
cardiovascular events.

The PIONEER phase 3a clinical development program for oral
semaglutide was a global development programme that enrolled 9,543
people with type 2 diabetes across 10 clinical trials.

Novo Nordisk is a global healthcare company with more than 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 43,200 people in 80 countries and markets its
products in more than 170 countries. For more information, visit
novonordisk.com (https://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. Results of the PIONEER 6 trial. Oral Semaglutide: The PIONEER
Program Trials Symposium. 79th Annual Scientific Sessions of the
American Diabetes Association. 11 June 2019.
2. Husain M et al. Oral Semaglutide and Cardiovascular Outcomes in
Patients with Type 2 Diabetes. NEJM 2019. 10.1056/NEJMoa1901118

Further information

Media:
Katrine Sperling +45 4442 6718 krsp@novonordisk.com
Michael Bachner (US) +1 609 664 7308 mzyb@novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Valdemar Borum Svarrer +45 3079 0301 jvls@novonordisk.com
Ann Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com
Kristoffer Due Berg (US) +1 609 235 2989 krdb@novonordisk.com

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