Tresiba® Trial Shows that People with Type 2 Diabetes who Avoid Severe Hypoglycaemia have a Reduced Risk of Death

PR70097

LISBON, Portugal, September 15, 2017 /PRNewswire=KYODO JBN/ --

- Symposium: S33

Novo Nordisk today announced new analyses from the multinational,

double-blinded DEVOTE trial showing that people with type 2 diabetes who

experience severe hypoglycaemia (low blood sugar levels) are at greater risk of

death. The risk was four-fold higher 15 days after an event and two and a

half-fold higher anytime following an episode of severe hypoglycaemia.[1] In

addition, results also showed that daily fluctuations in blood sugar levels in

people with type 2 diabetes are associated with a higher risk of death. The

results were presented at the European Association for the Study of Diabetes

53rd Annual Meeting (EASD) and simultaneously published in Diabetologia.[1],[2]

"Episodes of severe hypoglycaemia are not only distressing for patients and

potentially dangerous, they are also associated with an increased risk of

death," said Dr Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute,

Mount Sinai Hospital, University of Toronto, Canada and member of the DEVOTE

Steering Committee. "These results highlight the importance of maintaining low

variability in blood sugar levels and reducing the risk of severe hypoglycaemia

when treating people with type 2 diabetes."

In the DEVOTE trial, Tresiba® (insulin degludec) reduced the rate of severe

hypoglycaemia by 40% and the rate of nocturnal severe hypoglycaemia by 53%

compared to insulin glargine U100 in people with type 2 diabetes.[3] Similar

reductions were seen in the SWITCH 2 trial with 51% lower rates of severe

hypoglycaemia during the full treatment period of the trial and a 42% reduction

in the rate of nocturnal hypoglycaemia compared to insulin glargine U100 in

people with type 2 diabetes.[4]

Studies have also shown that Tresiba® provides significantly lower variability

in blood sugar levels compared to insulin glargine U100 and U300.[5],[6]

About DEVOTE

DEVOTE is a multinational, double-blinded clinical trial which investigated the

cardiovascular safety of Tresiba® compared with insulin glargine U100 over 104

weeks. DEVOTE is the first cardiovascular outcomes trial (CVOT) comparing two

basal insulins and enrolled more than 7,500 people with type 2 diabetes. All

participants had a high risk of, or existing, cardiovascular disease and were

already receiving standard of care to reduce their cardiovascular risk.[3] The

trial demonstrated that Tresiba® does not increase cardiovascular risk compared

with insulin glargine U100, and provides a significant reduction in the rate of

severe and nocturnal severe hypoglycaemia at similar levels of glycaemic

control.[3]

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.[6],[7] It provides low variability in blood glucose levels and a lower

risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine

U100.[3],[7] 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.[7] 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 41,400 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.    Zinman B, Marso SP, Poulter NR, et al. Day-to-day fasting glycaemic

variability in DEVOTE: associations with severe hypoglycaemia and

cardiovascular outcomes (DEVOTE 2). Diabetologia. 2017; TBC:TBC. (In press).

2.    Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal relationships

between severe hypoglycaemia, cardiovascular outcomes and mortality.

Diabetologia. 2017; TBC:TBC. (In press).

3.    Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec

versus glargine in type 2 diabetes. N Engl J Med. 2017; 377:723-732.

4.    Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs

insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: The

SWITCH 2 randomized clinical trial. JAMA. 2017; 318:45-56.

5.    Heise T, Norskov M, Nosek L, et al. Insulin degludec: Lower day-to-day

and within-day variability in pharmacodynamic response compared with insulin

glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017; 19:1032-1039.

6.    Haahr H, Heise T. A review of the pharmacological properties of insulin

degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800.

7.    EMA. Tresiba® 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: September 2017.

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

Hanna Ögren

+45-3079-8519

haoe@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Christina Jensen

+45-3079-3009

cnje@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

SOURCE: Novo Nordisk