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