Ryzodeg® Offers a Simpler Solution With Once-Daily Dosing and Reduced Risk of Nocturnal Hypoglycaemia vs Insulin Glargine U100 Plus Insulin Aspart

Berlin (ots/PRNewswire) -

When treated with once-daily Ryzodeg®, people with type 2 diabetes
achieved similar blood sugar control with half the number of daily
injections, significantly lower total daily insulin dose and
significantly reduced risk of nocturnal hypoglycaemia in the Step by
Step trial compared with once-daily insulin glargine U100 plus
once-daily insulin aspart after 26 weeks. Ryzodeg® is a combination
of insulin degludec and insulin aspart (IDegAsp) in one pen for the
treatment of people with type 2 diabetes. The results from the Step
by Step trial were presented today at the 54th Annual Meeting of the
European Association for the Study of Diabetes (EASD 2018) in Berlin,
Germany.[1]

"Complicated treatment regimens that require multiple injections
at different times of day can be difficult for patients to adhere to,
potentially leading to poor blood sugar control," said Dr Athena
Philis-Tsimikas, Step by Step lead investigator and corporate vice
president, Scripps Whittier Diabetes Institute. "These trial results
show that once-daily IDegAsp can offer people with type 2 diabetes a
much simpler option with fewer injections compared with insulin
glargine U100 plus insulin aspart, to achieve effective blood sugar
control."

After 26 weeks, people in the once-daily Ryzodeg® treatment arm
received 50% fewer injections and significantly fewer total daily
insulin units (12%) compared with insulin glargine U100 plus insulin
aspart.[1]

Once-daily Ryzodeg® demonstrated a statistically significant 45%
lower rate of nocturnal severe or blood glucose (BG)-confirmed
symptomatic hypoglycaemic episodes compared with insulin glargine
U100 plus insulin aspart after 26 weeks. The rate of overall severe
or BG-confirmed hypoglycaemic episodes was numerically lower for
once-daily Ryzodeg® compared with insulin glargine U100 plus insulin
aspart.[1]

"Hypoglycaemic episodes, especially at night, are often
frightening for people with diabetes. Not only does once-daily
Ryzodeg® offer a much simpler solution but it also significantly
reduces the risk of nocturnal hypoglycaemia compared with basal-bolus
treatment," said Mads Krogsgaard Thomsen, executive vice president
and chief science officer of Novo Nordisk. "By reducing the number of
daily injections, we hope that Ryzodeg® can help reduce the burden of
diabetes, and make it easier for people with diabetes to comply with
treatment and help them towards achieving better outcomes."

About the trial

The Step by Step trial compared the efficacy and safety of
Ryzodeg® with insulin glargine U100 plus insulin aspart in people
with type 2 diabetes treated with basal insulin, with or without oral
antidiabetic treatment in need of insulin intensification.[1] The
trial was a 38-week, international, open-label, randomised,
treat-to-target trial involving 532 adults from seven countries.[1,2]
If participants were not on target at Week 26 or Week 32, they went
on to receive an intensified insulin regimen, as would happen in
real-life clinical practice.[1] The primary endpoint was change from
baseline in HbA1c after 26 weeks.[1,2] Key secondary endpoints
included change from baseline in HbA1c after 38 weeks, responder rate
(%) for HbA1c <7% after 26 and 38 weeks, and number of
treatment-emergent severe or BG-confirmed symptomatic hypoglycaemic
episodes during 26 and 38 weeks.[1,2]

About Ryzodeg®

Ryzodeg® is a combination of two distinct insulin analogues
(insulin degludec and insulin aspart in the ratio of 70% and 30%),
making it the first combination of a long-acting basal insulin and a
mealtime insulin in one pen for people with type 1 and 2
diabetes.[3-6] Ryzodeg® incorporates the benefits of the insulin
degludec molecule.[7,8] Ryzodeg® is given as an injection once or
twice daily with main meal(s).[4] Ryzodeg® offers a simpler regimen
with fewer injections than basal and bolus therapy, in one pen.[3]

Ryzodeg® received its first regulatory approval in December 2012
and European Medicines Agency approval in January 2013. Since then,
Ryzodeg® has been approved in more than 90 countries, including the
US in September 2015. It is now commercially available in 20
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://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).

References

1. Gupta Y, Astamirova K, Fita E, et al. Similar glycaemic
control and less nocturnal hypoglycaemia with intensification of
IDegAsp QD or BID vs glargine U100 QD + IAsp 1-3 in adults with type
2 diabetes. Abstract and poster presented at the 54th Annual Meeting
of the European Association for the Study of Diabetes (EASD), Berlin,
Germany; 1-5 October 2018.

2. Clinicaltrials.gov. A 38 Week Trial Comparing Effect and
Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus
Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal
Insulin With or Without Oral Antidiabetic Treatment in Need of
Treatment Intensification. Available at: https://clinicaltrials.gov/c
t2/show/NCT02906917?term=NN5401-4266&rank=1 Last accessed: September
2018.

3. Heise T, Tack CJ, Cuddihy R, et al. A new-generation
ultra-long-acting basal insulin with a bolus boost compared with
insulin glargine in insulin-naïve people with type 2 diabetes: a
randomized, controlled trial. Diabetes Care. 2011; 34:669-674.

4. EMA. Ryzodeg® Summary of Product Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_Information/human/002499/WC500139011.pdf Last accessed: September
2018.

5. Fulcher GR, Christiansen JS, Bantwal G, et al. Comparison of
insulin degludec/insulin aspart and biphasic insulin aspart 30 in
uncontrolled, insulin-treated type 2 diabetes: a phase 3a,
randomized, treat-to-target trial. Diabetes Care. 2014; 37:2084-2090.

6. De Rycke A, Mathieu C. Degludec - first of a new generation
of insulins. European Endocrinology. 2011; 7:84-87.

7. 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.

8. Haahr H, Fita EG, Heise T. A Review of Insulin
Degludec/Insulin Aspart: Pharmacokinetic and Pharmacodynamic.
Properties and Their Implications in Clinical Use. Clin
Pharmacokinet. 2017; 56:339-354.

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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