New Data Confirm Tresiba(R) U200 Delivers Significantly Lower Rates of Confirmed Hypoglycaemia Versus Insulin Glargine U100

PR61802

STOCKHOLM, Sept. 15, 2015 / PRN=KYODO JBN/ --

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    New data presented today at the 51st annual meeting of the European

Association for the Study of Diabetes (EASD) show that patients with type 2

diabetes receiving the U200 formulation of Tresiba(R) (insulin degludec)

experienced significantly lower rates of confirmed hypoglycaemia and

significantly reduced mean fasting blood glucose compared to those receiving

insulin glargine U1001. Tresiba(R) U200 is twice as concentrated as U100,

allowing patients to inject up to 160 units in a single injection, rather than

in two separate injections.

    "These findings provide valuable insights to physicians treating patients

with type 2 diabetes, many of whom require higher doses of insulin," commented

Dr Mark Warren, lead study investigator. "The more concentrated formulation of

Tresiba(R) also means fewer injections, which will be a welcome option for

those patients who require higher than 80 units."

    The 32-week, open-label, crossover, treat-to-target trial compared the

safety, efficacy and patient-reported outcomes of Tresiba(R) U200 to insulin

glargine U100 in patients who might benefit from a low-volume basal insulin. In

the study, patients with type 2 diabetes also reported higher satisfaction with

Tresiba(R) U200, highlighting an overall preference versus insulin glargine

U100. Patients receiving the more concentrated formulation of Tresiba(R) also

reported numerically lower cases of nocturnal hypoglycaemia and lower weight

change and rated the delivery device FlexTouch(R) significantly better for

function1.     After 16 weeks, the study demonstrated1:

    - Tresiba(R) U200 delivered non-inferiority to insulin glargine with

respect to change in patient blood glucose levels

     - Significantly reduced mean fasting plasma glucose with Tresiba(R) U200

versus insulin glargine (-0.82 mmol/L vs -0.05 mmol/L, p＜0.05)

     - Significantly lower confirmed hypoglycaemia rate with Tresiba(R) U200

versus insulin glargine (estimated rate ratio [ERR]; 0.59, p＜0.05)

     - Tresiba(R) U200 delivered numerically lower nocturnal hypoglycaemia rate

versus insulin glargine (ERR; 0.66)

     - Lower mean weight change with Tresiba(R) U200 versus insulin glargine

(0.42 kg vs 1.04kg).

    In addition, 32.1% of patients in the Tresiba(R) U200 arm and 35.2% in the

insulin glargine arm reported adverse events. Of these, 2.9% and 2.8%

respectively were serious adverse events requiring third party intervention.

    About Tresiba(R)

    Tresiba(R) (insulin degludec) is a once-daily basal insulin that provides

duration of action beyond 42 hours2,3. 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 needed2,4,5. Tresiba(R) U200

enables up to 160 units of insulin to be dosed in a single injection, allowing

people with diabetes to administer the same amount of insulin in half the

volume as they are able to with current U100 formulations. No dose conversion

is needed when transferring a patient from U100 to U200.

    Tresiba(R) received its first regulatory approval in September 2012 and has

since been approved in more than 60 countries globally.

    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 39,700 people in

75 countries and markets its products in more than 180 countries. Novo

Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are

listed on the New York Stock Exchange (NVO). For more information, visit

novonordisk.com [http://C:\Users\nip\Desktop\Corporate

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    References

    1) Warren M, et al. Efficacy, patient reported outcomes and safety of

insulin degludec U200 compared with insulin glargine in patients with type 2

diabetes (T2D) requiring high-dose insulin. Presented at the 51st annual

meeting of the European Association for the Study of Diabetes (EASD);

Stockholm, Sweden, 14-18 September 2015.

     2) Tresiba(R) Summary of Product Characteristics. Bagsvard, Denmark, Novo

Nordisk A/S; June 2015.

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

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

     4) Meneghini L, 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. Diabetes Care. 2013;36:858-64.

     5) Mathieu C, 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.

J Clin Endocrinol Metab. 2013;98:1154-62.

Source: Novo Nordisk