The trial was designed to investigate the effects of Ryzodeg on blood sugar control and hypoglycaemia reduction versus BIAsp 30, both at the end of Ramadan and 4 weeks post-Ramadan.
Abu Dhabi, UAE, 7 December 2017 - In people with type 2 diabetes who fast during Ramadan, Ryzodeg® (insulin degludec/insulin aspart) reduced the overall rate of low blood sugar (hypoglycaemia) including severe episodes by 62% and the rate of nocturnal hypoglycaemia by 74% versus biphasic insulin aspart 30 (BIAsp 30 [NovoMix® 30]). The trial results were presented today at the International Diabetes Federation Congress 2017 (IDF 2017).1
“Millions of people with type 2 diabetes participate in Ramadan every year and we know that periods of prolonged fasting can increase the risk of hypoglycaemia,” said lead investigator Dr Mohamed Hassanein of the Dubai Hospital, Dubai Health Authority, UAE and chair of the Diabetes and Ramadan International Alliance (DAR). “This highlights the importance of people with type 2 diabetes preparing for Ramadan with their doctor and discussing treatment options for preventing episodes of hypoglycaemia.”
It is estimated that worldwide over 116 million Muslims with diabetes may choose to fast during Ramadan.2 Muslims with type 2 diabetes who fast during Ramadan have up to a 7.5-fold increased risk of severe hypoglycaemia.3
“This trial has shown that Ryzodeg® is not only a simple treatment option which can make daily life easier for people with diabetes. Ryzodeg® also reduces the risk of potentially dangerous episodes of hypoglycaemia in people with type 2 diabetes who choose to fast during Ramadan,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The trial was designed to investigate the effects of Ryzodeg® on blood sugar control and hypoglycaemia reduction versus BIAsp 30, both at the end of Ramadan and 4 weeks post-Ramadan. There was no difference in overall blood sugar control between Ryzodeg® and BIAsp 30.1
About the trial
The Ramadan trial compared the efficacy and safety of Ryzodeg® twice daily and BIAsp 30 (NovoMix®) twice daily in subjects with type 2 diabetes before, during and after Ramadan. The trial was a 28-week, international, open-label, randomised, treat-to-target trial involving 263 adults from five countries with large Muslim populations (Algeria, India, Lebanon, Malaysia and South Africa). The primary endpoint was change in HbA1c from baseline to the end of the month of Ramadan (four-week period). Secondary confirmatory endpoints included rates of blood sugar confirmed, nocturnal and severe hypoglycaemia.1
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 basal insulin with an ultra-long duration of action and a mealtime insulin in one pen for people with type 1 and 2 diabetes.4-6 Ryzodeg® incorporates the benefits of the degludec molecule.7,8 Ryzodeg® is given as an injection once or twice daily with the main meal(s).4 Ryzodeg® offers a simpler regimen with fewer injections than basal and bolus therapy, in one pen.9
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 70 countries, including the US in September 2015. It is now commercially available in 13 countries.4
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 |
| Hanna Ögren | +45 3079 8519 | haoe@novonordisk.com |
| Anders Mikkelsen | +45 3079 4461 | armk@novonordisk.com |
| Christina Kjær | +45 3079 3009 | cnje@novonordisk.com |
| Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com |
References
1. Hassanein M, Echtay A, Malek R, et al. Efficacy and safety of insulin degludec/insulin aspart in adults with type 2 diabetes fasting during Ramadan. Presented at the International Diabetes Federation Congress 2017, Abu Dhabi, UAE. 4-8 December 2017.
2. International Diabetes Federation and the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical Guidelines. Brussels, Belgium: International Diabetes Federation, 2016. Available at: https://www.idf.org/e-library/guidelines/87-diabetes-and-ramadan-practical-25. Last accessed: November 2017.
3. Salti I, Benard E, Detournay B, et al. A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004;27:2306-2311.
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: November 2017.
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. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clinical Pharmacokinetics. 2014;53:787-800.
8. 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.
9. 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.
