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

PR79145

SAN FRANCISCO, June 12, 2019 /PRNewswire=KYODO JBN/ --

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, Facebook, Twitter, LinkedIn, YouTube.

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

SOURCE: Novo Nordisk