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

Berlin (ots/PRNewswire) -

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® (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® 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® 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®, 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® 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® was calculated using the reduction in hypoglycaemia seen
with Tresiba® 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® 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® 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®

Tresiba® (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® 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® Summary of Product Characteristics. Available at: ht
tp://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

ots Originaltext: Novo Nordisk A/S
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