2017年12月7日

Novo Nordisk

Tresiba(R) Reduces Hypoglycaemia Regardless of Blood Sugar Level

Tresiba(R) Reduces Hypoglycaemia Regardless of Blood Sugar Level

PR71409

ABU DHABI, UAE, Dec. 7, 2017 /PRNewswire=KYODO JBN/ —

    
    People with either type 1 or type 2 diabetes treated with Tresiba(R) had
fewer episodes of low blood sugar (hypoglycaemia) compared with people on
insulin glargine U100 regardless of whether they had achieved blood sugar
targets.[1] These new post-hoc analyses from the SWITCH 1 and 2 trials were
presented at the International Diabetes Federation (IDF) Annual Congress in Abu
Dhabi today.[2],[3]

    "Achieving target blood sugar levels can be a constant challenge for people
with diabetes treated with insulin, and this is made even more complex by the
risk of hypoglycaemia," said Mads Krogsgaard Thomsen, executive vice president
and chief science officer at Novo Nordisk. "Tresiba(R) has consistently been
shown to provide stable blood sugar control while at the same time reducing
hypoglycaemia compared with insulin glargine U100; it is very encouraging to
see that treatment with Tresiba(R) helps people to achieve blood sugar control
with fewer episodes of hypoglycaemia regardless of their blood sugar levels in
this analysis."

    The findings of these analyses are consistent with the results of the main
SWITCH trials which demonstrated significantly lower rates of overall
symptomatic hypoglycaemia versus insulin glargine U100 in people with type 1
and type 2 diabetes.[2],[3]

    About hypoglycaemia

    Hypoglycaemia occurs when blood sugar levels are too low and cannot provide
the body’s organs with the energy they need. Hypoglycaemia can cause a range of
symptoms including confusion, trembling, sweating, increased heart rate,
difficulty with concentration and/or speech and in severe cases can lead to a
seizure or coma.[4]-[6] Severe hypoglycaemia can cause extensive damage to the
body and is significantly associated with cardiovascular death.[7] Every month,
46.5% of people with type 2 diabetes and 83.0% of people with type 1 diabetes
experience a hypoglycaemic episode.[8]

    About the new analyses

    The analyses, based on the recent SWITCH trials, separated people into two
groups depending on whether they had achieved target blood sugar levels
(defined as HbA1c of 7.0% or less) during the maintenance period of the
trial.[1] Target blood sugar levels are those recommended by the joint
guidelines of the American Diabetes Association and the European Association
for the Study of Diabetes.[9]

    About SWITCH 1 and 2

    SWITCH 1 and SWITCH 2 were two phase 3b, 64-week, double-blind, randomised,
treat-to-target, 2-period crossover trials that investigated the hypoglycaemia
profile of Tresiba(R) compared with insulin glargine U100 in people with type 1
and type 2 diabetes, respectively. The trial design included a titration period
in which the doses of study treatments (Tresiba(R) or insulin degludec U100)
were gradually increased over a 16 week period, followed by a 16 week
maintenance period during which a constant dose of study treatment was
maintained.[2],[3] The primary endpoint was the number of severe or blood
glucose-confirmed symptomatic hypoglycaemic episodes observed in participants
during the maintenance period.[2],[3]

    About Tresiba(R)

    Tresiba(R) (insulin degludec) is a once-daily basal insulin that provides a
duration of action beyond 42 hours with a flat and stable glucose-lowering
effect.[10],[11] It has been shown to provide a lower risk of overall,
nocturnal and severe hypoglycaemia, and low variability in blood glucose levels
versus insulin glargine U100.[11],[12] Tresiba(R) received its first regulatory
approval in September 2012 and has since been approved in more than 80
countries globally. It is now commercially available in more than 50 countries.

    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 obesity,
haemophilia, growth disorders and other serious chronic diseases. Headquartered
in Denmark, Novo Nordisk employs approximately 41,700 people in 77 countries
and markets its products in more than 165 countries. For more information,
visit novonordisk.com [https://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  

    Investors:   
    Peter Hugreffe Ankersen +45 3075 9085   phak@novonordisk.com  
    Hanna Ögren             +45 3079 8519   haoe@novonordisk.com  
    Anders Mikkelsen        +45 3079 4461   armk@novonordisk.com  
    Christina Kjær          +45 3079 3009   cnje@novonordisk.com  
    Kasper Veje (US)        +1 609 235 8567 kpvj@novonordisk.com  


    References  

    1.    Gumprecht J, Lane W, Chaykin LB, et al. Lower rate of hypoglycaemia
with insulin degludec vs. insulin glargine U100 after adjusting for HbA1c in
SWITCH 1 and 2. Poster presentation. International Diabetes Federation (IDF)
Annual Congress 2017, Abu Dhabi, UAE. December 2017.

    2.    Lane W, Bailey TS, Gerety G, et al. Effect of insulin degludec vs
insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: The
SWITCH 1 randomized clinical trial. JAMA. 2017;318:33-44.

    3.    Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs
insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: The
SWITCH 2 randomized clinical trial. JAMA. 2017;318:45-56.

    4.    Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes:
a report of a workgroup of the American Diabetes Association and the Endocrine
Society. Diabetes Care. 2013;36:1384-1395.

    5.    International Hypoglycaemia Study Group. Diagnosis of hypoglycaemia.
Available online at
http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last accessed
November 2017.

    6.    Cryer P. Hypoglycemia, functional brain failure, and brain death.
Journal of Clinical Investigation. 2007;117:868-870.

    7.    Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal
relationships between severe hypoglycaemia, cardiovascular outcomes and
mortality. Diabetologia. 2017.

    8.    Khunti K, Alsifri S, Aronson R, et al. Rates and predictors of
hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1
and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2016;18:907-915.

    9.    Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of
Hyperglycemia in Type 2 Diabetes, 2015: A Patient Centered Approach. Diabetes
Care 2015;38:140-149.

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

    11.    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: November 2017.

    12.    Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of
degludec versus glargine in type 2 diabetes. N Engl J Med. 2017;377:723-732.


SOURCE: Novo Nordisk