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, 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® 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 [email protected]
Åsa Josefsson +45-3079-7708 [email protected]
Investors:
Peter Hugreffe Ankersen +45-3075-9085 [email protected]
Anders Mikkelsen +45-3079-4461 [email protected]
Valdemar Borum Svarrer +45-3079-0301 [email protected]
