Tresiba(R) 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

PR68908

SAN DIEGO, June 13, 2017 /PR Newswire=KYODO JBN/ --

    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(R) (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 (R) 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(R) 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(R) 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(R) in DEVOTE was generally consistent with

previous Tresiba(R) 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(R) 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(R) (insulin

degludec) compared to insulin glargine U100. In the trial, 7,637 people

(Tresiba(R): 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(R) 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(R)

    Tresiba(R) (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(R) allows for flexibility in day-to-day dosing time with a

minimum of eight hours between injections.[2] Tresiba(R) 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(R) Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/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 Ogren

    +45-3079-8519

    haoe@novonordisk.com

    Anders Mikkelsen

    +45-3079-4461

    armk@novonordisk.com

    Kasper Veje (US)

    +1-609-235-8567

    kpvj@novonordisk.com

SOURCE: Novo Nordisk