Tresiba® Demonstrated Lower Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Compared With Insulin Glargine U300

Bagsværd, Denmark (ots/PRNewswire) -

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Results from a study comparing the pharmacodynamics of Tresiba®
(insulin degludec) with insulin glargine U300 in people with type 1
diabetes were presented today at the 16th Annual Diabetes Technology
Meeting in Bethesda, US. Treatment with Tresiba® (0.4 U/kg) resulted
in lower day-to-day and within-day variability* in glucose-lowering
effect,compared with insulin glargine U300 (0.4 U/kg).[1]

The study showed that the day-to-day variability was approximately
four times lower with Tresiba® than with insulin glargine U300.
Within-day variability was approximately 40% lower with Tresiba®,
with the glucose-lowering effect being more evenly distributed across
24 hours compared to insulin glargine U300.[1] In addition, insulin
glargine U300 showed a 30% lower potency assessed by the total
glucose-lowering effect compared to Tresiba®.[1]

"While large-scale head-to-head trials are needed to compare the
efficacy and safety of new insulins, pharmacodynamic studies are
important, as they enable us to better understand their
pharmacological properties. The more stable the glucose lowering
profile of insulin, the easier it is to titrate and can help reduce
the risk of hypoglycaemia and hyperglycaemia in patients with
diabetes," says Dr Tim Heise, lead scientist at the Profil Institute
in Germany.

*within-day variability was assessed in a post-hoc analysis and
calculated as the relative fluctuation, in order to account for the
difference in potency between Tresiba® and insulin glargine U300.

About the NN1250-4227 study

This was a phase 1, single-centre, double-blind, two-period,
cross-over trial, where people with type 1 diabetes were randomly
assigned to receive Tresiba® or insulin glargine U300 at a dose of
0.4 U/kg/day. A total of 57 people completed the study. Both
treatments were administered once daily for 12 days, followed by a
7-21 day period in which the participants received no study
treatment, before being crossed over to receive the other treatment
for a further 12 days. In order to assess the pharmacodynamic
variability in the glucose-lowering effect of Tresiba® and insulin
glargine U300, each participant underwent six 24-hour glucose clamps
(three during each 12-day study period) performed at steady state
(where glucose levels are stabilised in the participants).[1]

About Tresiba®

Tresiba® is a once-daily basal insulin that provides a duration of
action beyond 42 hours.[2],[3] It is important for people with type 1
and type 2 diabetes to establish a routine for insulin treatment. On
occasions when administration at the same time of day is not
possible, Tresiba® allows for flexibility in day-to-day dosing time
when needed.[2],[4],[5] Tresiba® received its first regulatory
approval in September 2012 and has since been approved in more than
80 countries globally. It was most recently approved by the FDA in
the United States on 26 September 2015.

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 42,600 people in 75 countries and markets its products
in more than 180 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)

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7708

aajf@novonordisk.com

Michael Bachner (US)

+1-609-664-7308

mzyb@novonordisk.com
Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Melanie Raouzeos

+45-3075-3479

mrz@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

References

1. Heise T, Nørskov M, Nosek L, et al. Insulin degludec:
Four-times lower pharmacodynamic within-patient variability compared
to insulin glargine U300 in type 1 diabetes. Annual Diabetes
Technology Meeting 2016, Poster presentation

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: November 2016

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

4. Meneghini L, Atkin SL, Gough SC, et al. The efficacy and safety
of insulin degludec given in variable once-daily dosing intervals
compared with insulin glargine and insulin degludec dosed at the same
time daily: a 26-week, randomized, open-label, parallel-group,
treat-to-target trial in individuals with type 2 diabetes. Diabetes
Care. 2013; 36:858-864

5. Mathieu C, Hollander P, Miranda-Palma B, et al. Efficacy and
safety of insulin degludec in a flexible dosing regimen vs insulin
glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week
randomized, treat-to-target trial with a 26-week extension. The
Journal of Clinical Endocrinology & Metabolism. 2013; 98:1154-1162

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