People With Diabetes May Achieve Improved Glycaemic Control With Tresiba(R) Versus Glargine U100, Without an Increase in Hypoglycaemia

PR75490

BERLIN, Oct. 2, 2018 /PRNewswire=KYODO JBN/ --

      According to results of a post-hoc analysis people with both type 1 and

type 2 diabetes in clinical practice may achieve improved glycaemic control

(HbA1c) with Tresiba (R) (insulin degludec) versus insulin glargine U100,

without an increase in hypoglycaemia (potentially dangerous low blood

sugar).[1] The results of this new analysis from the SWITCH 1 and 2 trials were

presented today at the 54th Annual Meeting of the European Association for the

Study of Diabetes (EASD 2018) in Berlin, Germany.

    Lowering blood sugar to target levels is important to help prevent the

complications of diabetes, but reductions can increase the risk of

hypoglycaemia. In this post-hoc analysis, based on the reduction in

hypoglycaemia risk with Tresiba(R) found in the maintenance period of the

SWITCH trials, it is estimated that people with diabetes may achieve a mean

HbA1c reduction of 0.70% (type 1 diabetes) and 0.96% (type 2 diabetes) with

Tresiba(R) compared to insulin glargine U100 at similar rates of

hypoglycaemia.[1]

    "Episodes of hypoglycaemia can be dangerous for people with diabetes and

can often be a significant barrier to achieving glycaemic control," said Mads

Krogsgaard Thomsen, executive vice president and chief science officer of Novo

Nordisk. "These findings add to already published evidence showing a reduced

risk of hypoglycaemia with Tresiba(R), providing further confidence that this

treatment may help people with diabetes achieve blood sugar control."

    This post-hoc analysis is based on patient-level data from the SWITCH 1 and

2 trials. The SWITCH trials demonstrated statistically significantly lower

rates of overall symptomatic hypoglycaemia versus insulin glargine U100 in

people with type 1 and type 2 diabetes.[2,3]

    About the new analysis This post-hoc analysis investigated the individual

patient-level risk of hypoglycaemia by HbA1c with Tresiba(R) and insulin

glargine U100 to compare how glycaemic control differs at a similar rate of

hypoglycaemia. For each trial participant at each visit their HbA1c level was

linked with the number of hypoglycaemic events (blood glucose-confirmed [<3.1

mmol/L] with symptoms or severe [third-party assistance]) since last visit.

Reduction of hypoglycaemia risk with Tresiba(R) was calculated using the

reduction in hypoglycaemia seen with Tresiba(R) compared to insulin glargine

U100 in the SWITCH trials.[1]

    About SWITCH 1 and 2 SWITCH 1 and SWITCH 2 were two phase 3b, 64-week,

double-blinded, 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 and at least one risk

factor for hypoglycaemia, respectively. The trial design included a titration

period in which the doses of study treatments (Tresiba(R) or insulin glargine

U100) were gradually increased over a 16-week period, followed by a 16-week

maintenance period during which a stable 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 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 speech.[4,5]

In severe cases it can lead to a seizure, coma or even death.[4,6]

    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.[7,8] Tresiba led to an effective reduction in

HbA1c in clinical trials and showed a lower risk of hypoglycaemia in certain

patient populations and studies compared to insulin glargine U100,  in

particular in type 2 diabetes.[2,3,8,9] It also provides for a lower day-to-day

variability in glucose lowering effect versus insulin glargine U100.[8]

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

since been approved in more than 80 countries globally. It is commercially

available in more than 61 countries.

    About Novo Nordisk Novo Nordisk is a global healthcare company with 95

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 43,100 people in 79 countries

and markets its products in more than 170 countries. For more information,

visit novonordisk.com [https://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 ]

    References

    1) Pedersen-Bjergard U, Philis-Tsimikas A, Lane W, et al. Relationship

between HbA1c and hypoglycaemia risk in individual patients comparing insulin

degludec with insulin glargine U100. Poster presented at the 54th Annual

Meeting of the European Association for the Study of Diabetes (EASD), Berlin,

Germany; 1-5 October 2018.     

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:

July 2018.     

6) Cryer PE. Hypoglycemia, functional brain failure, and brain death. J Clin

Invest. 2007;117:868-870.     

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

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

8) 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: July 2018.     

9) 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.

    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

Anders Mikkelsen     

+45-3079-4461     

armk@novonordisk.com

Valdemar Borum Svarrer     

+45-3079-0301     

jvls@novonordisk.com

SOURCE: Novo Nordisk