Tresiba(R) (Insulin Degludec Injection U-100) Demonstrated Significantly Lower Rates of Overall, Nocturnal and Severe Hypoglycaemia vs Insulin Glargine U-100

PR64756

NEW ORLEANS, June 12, 2016 /PRNewswire=KYODO JBN/ --

    This material is intended for global medical media only.

    For journalistic assessment and preparation before publication.

    Abstracts 87-LB and 90-LB

    New findings from the two phase 3b SWITCH trials showed that treatment with

long-acting basal insulin Tresiba(R) (insulin degludec injection U-100)

resulted in significantly lower rates of overall, nocturnal and severe

hypoglycaemia compared with insulin glargine U-100.1,2 Results from the SWITCH

1 and 2 trials, the first completed double-blinded basal insulin studies

evaluating the safety profile and efficacy of Tresiba(R) vs insulin glargine

U-100,1,2 were presented today at the American Diabetes Association

76th Scientific Sessions in New Orleans, US.

    In SWITCH 1, patients with type 1 diabetes taking Tresiba(R) compared with

insulin glargine U-100 experienced: a rate reduction of 11% in overall

symptomatic blood glucose(BG) confirmed hypoglycaemic episodes (95% confidence

interval CI: 0.85; 0.94); a rate reduction of 36% in nocturnal BG confirmed

symptomatic hypoglycaemic episodes (95% CI: 0.56; 0.73), and a rate reduction

of 35% severe hypoglycaemia (95% CI: 0.48; 0.89) during the maintenance

period.1 All of the above analyses showed similar results in the full treatment

period.

    In SWITCH 2, patients with type 2 diabetes taking Tresiba(R) compared with

insulin glargine U-100 experienced a rate reduction of 30% in overall BG

confirmed symptomatic hypoglycaemic episodes (95% CI: 0.61; 0.80) and a rate

reduction of 42% in nocturnal BG confirmed symptomatic hypoglycaemic episodes

(95% CI: 0.46; 0.74). The above analyses showed significant results in the full

treatment period. In the maintenance period, there was a trend towards lower

rates of severe hypoglycaemia in favour of Tresiba(R) vs insulin glargine

U-100. In the full treatment period, a significant 51% rate reduction in severe

hypoglycaemia was observed in patients receiving Tresiba(R) vs insulin glargine

U-100 (95% CI: 0.26; 0.94).2  

    "Hypoglycaemia is an ongoing challenge for people with type 1 and type 2

diabetes," said Dr. Wendy Lane, lead SWITCH 1 study investigator and clinical

endocrinologist at Mountain Diabetes and Endocrine Center in Asheville, N.C.,

U.S. "These findings are important for the diabetes community, and add to the

existing body of evidence for Tresiba(R)."

    Tresiba(R) (IDeg) was non-inferior to insulin glargine U-100 (IGlar U-100)

in reducing HbA1c in both treatment periods for both SWITCH 1 and 2 trials

(SWITCH 1 treatment period 1: IDeg 6.92% vs IGlar U-100 6.78%; SWITCH 1

treatment period 2: IDeg 6.95% vs IGlar U-100 6.97%; SWITCH 2 treatment period

1: IDeg 7.06% vs IGlar U-100 6.98%; SWITCH 2 treatment period 2: IDeg 7.08% vs

IGlar U-100 7.11%).1-3 The end-of-trial insulin doses were similar at the end

of each treatment period in both trials. The most common adverse events(greater

than or equal to5%) included nasopharyngitis, upper respiratory tract infections

and hypoglycaemia.3-5

    About SWITCH 1 and 2

    The two phase 3b, 2x32-weeks randomised, double-blind, crossover,

treat-to-target trials were initiated in January 2014 to compare the safety

profile and efficacy of Tresiba(R)and insulin glargine U-100. The overall

objective was to document the hypoglycaemia profile in type 1 diabetes and type

2 diabetes, respectively. During the maintenance period, the primary endpoint

studied was the number of treatment emergent severe or BG confirmed symptomatic

hypoglycaemic episodes. The two secondary endpoints included: the

number of treatment emergent severe or BG confirmed nocturnal episodes and the

proportion of subjects with one or more severe hypoglycaemic episodes. In

SWITCH 1, 501 people with type 1 diabetes were randomised to crossover

treatment with Tresiba(R) and insulin glargine U-100 in combination with

insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to

crossover treatment with Tresiba(R) and insulin glargine U-100 in combination

with oral antidiabetic drugs.

    About hypoglycaemia

    Hypoglycaemia is a frequent complication in people with type 1 and type 2

diabetes when low levels of blood glucose in the blood deprive muscles, cells

and the brain of the energy needed to function.6 Hypoglycaemia can be triggered

by multiple factors including taking too much insulin, not following the

prescribed meal schedule or participating in unusually strenuous or prolonged

exercise.

    About Tresiba(R)

    Tresiba(R) (insulin degludec injection U-100) is a once-daily basal insulin

that provides a duration of action beyond 42 hours.7,8 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.7,9,10 Tresiba(R) received its first regulatory approval in

September 2012 and has since been approved in more than 60 countries globally.

It was most recently approved by the FDA in the United States on 26 September

2015.

    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 41,600

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

    For more information, visit: http://www.novonordisk.com

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    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;

    Kasper Veje (US)

    +1-609-235-8567    

    kpvj@novonordisk.com

    References   

    1. Lane W, Bailey T, Gerety G, et al. SWITCH 1: Reduced Hypoglycaemia With

       Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in

       Patients With T1D at High Risk of Hypoglycaemia: A Randomised,

       Double-Blind Crossover Trial. Abstract 87-LB presented at the 76th

       Annual Scientific Sessions of the American Diabetes Association (ADA),

       New Orleans, USA. 11 June 2016.

    2. Wysham C, Bhargava A, Chaykin L, et al. SWITCH 2: Reduced Hypoglycaemia

       With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in

       Patients With T2D at High Risk of Hypoglycaemia: A Randomised,

       Double-Blind Crossover Trial. Abstract 90-LB presented at the 76th

       Annual Scientific Sessions of the American Diabetes Association (ADA),

       New Orleans, USA. 11 June 2016.

    3. Novo Nordisk. Data on file.

    4. Lane W, Bailey T, Gerety G, et al. SWITCH 1: Reduced Hypoglycaemia With

       Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in

       Patients With T1D at High Risk of Hypoglycaemia: A Randomised,

       Double-Blind Crossover Trial. Poster (#87-LB) presented at the 76th

       Annual Scientific Sessions of the American Diabetes Association (ADA),

       New Orleans, USA. 11 June 2016.

    5. Wysham C, Bhargava A, Chaykin L, et al. SWITCH 2: Reduced Hypoglycaemia

       With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in

       Patients With T2D at High Risk of Hypoglycaemia: A Randomised,

       Double-Blind Crossover Trial. Poster (#90-LB) presented at the 76th

       Annual Scientific Sessions of the American Diabetes Association ADA),

       New Orleans, USA; 11 June 2016.

    6. Willis WD, Diago-Cabezudo JI, Madec-Hily A, et al. Medical resource

       use, disturbance of daily life and burden of hypoglycemia in

       insulin-treated patients with diabetes: results from a European online

       survey. Expert Review of Pharmacoeconomics & Outcomes Research. 2013;

       13:123-30.

    7. 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 2016.

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

       degludec and their clinical relevance. Clinical Pharmacokinetics. 2014;

       53:787-800.

    9. 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.

   10. 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