Tresiba® (insulin degludec injection U-100) demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs insulin glargine U-100

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Abstracts 87-LB and 90-LB

New findings from the two phase 3b SWITCH trials showed that
treatment with long-acting basal insulin Tresiba® (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® 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®
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®
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® vs insulin glargine U-100.
In the full treatment period, a significant 51% rate reduction in
severe hypoglycaemia was observed in patients receiving Tresiba® 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®."

Tresiba® (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 (>=5%) 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® 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® 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® 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®

Tresiba® (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® allows for flexibility
in day-to-day dosing time when needed.7,9,10 Tresiba® 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,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

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® summary of product characteristics. Available
at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_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.

ots Originaltext: Novo Nordisk A/S
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