Tresiba® Demonstrated No Increased Risk Of Major Cardiovascular Events and Significant Reduction in Rates of Severe Hypoglycaemia Compared to Insulin Glargine U100 in the DEVOTE Trial

San Diego (ots/PRNewswire) -

Symposium: 3-CT-SY22

Novo Nordisk today announced the primary results from DEVOTE - the
first randomised, double-blind, treat-to-target, event-driven trial
comparing two basal insulins, Tresiba® (insulin degludec injection
100 U/mL) and insulin glargine U100, in adults with type 2 diabetes
at high risk of cardiovascular (CV) disease. The trial demonstrated
that Tresiba® met the primary endpoint of non-inferiority compared
with insulin glargine U100 for major adverse CV events (MACE) with a
hazard ratio (HR) of 0.91 (95% confidence interval [CI]: 0.78; 1.06,
p=0.209). Additionally, the findings for each component of MACE were
consistent with the primary endpoint, including first occurrence of
CV death (HR=0.96, 95% CI: 0.76; 1.21, p=0.714), non-fatal myocardial
infarction (HR=0.85, 95% CI: 0.68; 1.06, p=0.150) or non-fatal stroke
(HR=0.90, 95% CI: 0.65; 1.23, p=0.502).[1]

Results from the trial, involving 7,637 people with type 2
diabetes followed for approximately two years, were presented at the
American Diabetes Association's 77th Scientific Sessions (ADA 2017)
and also published simultaneously in the New England Journal of
Medicine.[1]

Results from the secondary endpoints of the trial showed a
significant reduction in the rate of severe (40%) and nocturnal
severe (53%) hypoglycaemia with Tresiba® vs. insulin glargine U100
(both p<0.001).* Additionally, post hoc analyses showed: similar
levels of glycaemic control with an end of trial HbA1c estimated
treatment difference of 0.01% (p=0.779) between the two treatment
groups and significantly lower fasting plasma glucose levels with
Tresiba® after 2 years vs. insulin glargine U100 (estimated treatment
difference -7.2 mg/dL, p<0.001).[1]

"In the DEVOTE trial degludec demonstrated no increase in the risk
of major cardiovascular events and significant reductions in the
rates of severe and nocturnal severe hypoglycaemia compared to
insulin glargine U100," said Dr Bernard Zinman of the
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital,
Toronto, Canada and member of the DEVOTE Steering Committee. "Risk of
cardiovascular disease and hypoglycaemia are important concerns for
those with type 2 diabetes and the results from DEVOTE add to the
mounting evidence that will play an important role in treatment
decisions."

The safety profile of Tresiba® in DEVOTE was generally consistent
with previous Tresiba® clinical trials.[1] In DEVOTE, systematic
collection of adverse events was limited to serious adverse events,
adverse events leading to permanent discontinuation of
investigational product (5.2% of patients in the Tresiba® arm and
5.8% of patients in the insulin glargine U100 arm), medication errors
leading to serious adverse events and adverse events related to
technical complaints.

*Severe hypoglycaemia was defined as an episode requiring
assistance of another person, and nocturnal severe defined as between
the hours of 00:01-05:59, inclusive.[1]

About DEVOTE

DEVOTE is a long-term, multi-national, randomised, double-blind
and event-driven trial conducted to confirm the CV safety of Tresiba®
(insulin degludec) compared to insulin glargine U100. In the trial,
7,637 people (Tresiba®: n=3,818, insulin glargine U100: n=3,819) with
type 2 diabetes at high risk of CV disease were randomised to
treatment with either Tresiba® or insulin glargine U100 in vial in
addition to standard of care.[1]

The primary endpoint in DEVOTE was time from randomisation to the
first occurrence of a three-component composite CV outcome comprising
CV death, non-fatal myocardial infarction or non-fatal stroke.
Secondary endpoints included severe hypoglycaemia, nocturnal severe
hypoglycaemia, HbA1c and fasting plasma glucose.[1]

About Tresiba®

Tresiba® (insulin degludec) is a once-daily basal insulin that
provides a duration of action beyond 42 hours with a flat and stable
glucose-lowering effect.[2],[3] It provides low within-day and
day-to-day variability and a lower risk of overall, nocturnal and
severe hypoglycaemia vs. insulin glargine U100.[1],[2] On occasions
when administration at the same time of day is not possible, Tresiba®
allows for flexibility in day-to-day dosing time with a minimum of
eight hours between injections.[2] Tresiba® received its first
regulatory approval in September 2012 and has since been approved in
more than 80 countries globally. It is now commercially available in
more than 50 countries.

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 42,000 people in 77 countries and markets its products
in more than 165 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. Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine
in Patients with Type 2 Diabetes at High Risk of Cardiovascular
Events (DEVOTE) Trial Results. Symposium 3-CT-SY22 at the 77th
Scientific Sessions of the American Diabetes Association (ADA). 12
June 2017. Manuscript in press.

2. EMA. Tresiba® Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_I
nformation/human/002498/WC500138940.pdf. Last accessed: June 2017.

3. Haahr H, Heise T. A review of the pharmacological properties of
insulin degludec and their clinical relevance. Clin Pharmacokinet.
2014; 53:787-800.

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

Hanna Ögren

+45-3079-8519

haoe@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

ots Originaltext: Novo Nordisk A/S
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