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

PR75469

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

When treated with once-daily Ryzodeg(R), 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(R)

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(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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(R)

Ryzodeg(R) 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(R) incorporates the

benefits of the insulin degludec molecule.[7,8] Ryzodeg(R) is given as an

injection once or twice daily with main meal(s).[4] Ryzodeg(R) offers a simpler

regimen with fewer injections than basal and bolus therapy, in one pen.[3]

Ryzodeg(R) received its first regulatory approval in December 2012 and European

Medicines Agency approval in January 2013. Since then, Ryzodeg(R) 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, Facebook, Twitter, LinkedIn, YouTube.  

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/ct2/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(R) Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_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

Source: Novo Nordisk