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

PR66507

BAGSVAERD, Denmark, Nov.12, 2016 /PRNewswire=KYODO JBN/ --

    This material is intended for global medical media only.  

    For journalistic assessment and preparation before publication.  

    Results from a study comparing the pharmacodynamics of Tresiba(R) (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(R) (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(R) than with insulin glargine U300. Within-day

variability was approximately 40% lower with Tresiba(R), 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(R).[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(R) 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(R) 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(R) 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(R)

    Tresiba(R) 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(R) allows for

flexibility in day-to-day dosing time when needed.[2], [4],[5] Tresiba(R)

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

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[http://www.twitter.com/novonordisk ],

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[http://www.Youtube.com/novonordisk ]

    Further information

    Media:

    Katrine Sperling

    +45-4442-6718

    krsp@novonordisk.com

    Asa 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 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

    References  

    1. Heise T, Norskov 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_Information/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

SOURCE: Novo Nordisk