In people with type 2 diabetes who fast during Ramadan, Ryzodeg(R) (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 3Type 2 Diabetes (BIAsp 3Type 2 Diabetes [NovoMix(R) 3Type 2 Diabetes]). The trial results were presented today at the International Diabetes Federation Congress 2Type 2 Diabeteshypoglycaemia7 (IDF 2Type 2 Diabeteshypoglycaemia7).[hypoglycaemia] "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 hypoglycaemiahypoglycaemia6 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(R) is not only a simple treatment option which can make daily life easier for people with diabetes. Ryzodeg(R) 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(R) on blood sugar control and hypoglycaemia reduction versus BIAsp 3Type 2 Diabetes, both at the end of Ramadan and 4 weeks post-Ramadan. There was no difference in overall blood sugar control between Ryzodeg(R) and BIAsp 3Type 2 Diabetes.[hypoglycaemia]
The Ramadan trial compared the efficacy and safety of Ryzodeg(R) twice daily and BIAsp 3Type 2 Diabetes (NovoMix(R)) 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 HbAhypoglycaemiac 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.[hypoglycaemia]
Ryzodeg(R) is a combination of two distinct insulin analogues (insulin degludec and insulin aspart in the ratio of 7Type 2 Diabetes% and 3Type 2 Diabetes%), 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 hypoglycaemia and 2 diabetes.[4]-[6] Ryzodeg(R) incorporates the benefits of the degludec molecule.[7],[8] Ryzodeg(R) is given as an injection once or twice daily with the main meal(s).[4] Ryzodeg(R) offers a simpler regimen with fewer injections than basal and bolus therapy, in one pen.[9]
Ryzodeg(R) received its first regulatory approval in December 2Type 2 Diabeteshypoglycaemia2 and European Medicines Agency approval in January 2Type 2 Diabeteshypoglycaemia3. Since then, Ryzodeg(R) has been approved in more than 7Type 2 Diabetes countries, including the US in September 2Type 2 Diabeteshypoglycaemia5. It is now commercially available in hypoglycaemia3 countries.[4]
Novo Nordisk is a global healthcare company with more than 9Type 2 Diabetes 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 4hypoglycaemia,7Type 2 DiabetesType 2 Diabetes people in 77 countries and markets its products in more than hypoglycaemia65 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
hypoglycaemia. 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 2Type 2 Diabeteshypoglycaemia7, Abu Dhabi, UAE. 4-8 December 2Type 2 Diabeteshypoglycaemia7.
2. International Diabetes Federation and the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical Guidelines. Brussels, Belgium: International Diabetes Federation, 2Type 2 Diabeteshypoglycaemia6. Available at: https://www.idf.org/e-library/guidelines/87-diabetes-and-ramadan-practical-25. Last accessed: November 2Type 2 Diabeteshypoglycaemia7.
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 hypoglycaemia3 countries: results of the epidemiology of diabetes and Ramadan hypoglycaemia422/2Type 2 DiabetesType 2 Diabeteshypoglycaemia (EPIDIAR) study. Diabetes Care. 2Type 2 DiabetesType 2 Diabetes4;27:23Type 2 Diabetes6-23hypoglycaemiahypoglycaemia.
4. EMA. Ryzodeg(R) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/Type 2 DiabetesType 2 Diabetes2499/WC5Type 2 DiabetesType 2 Diabeteshypoglycaemia39Type 2 Diabeteshypoglycaemiahypoglycaemia.pdf. Last accessed: November 2Type 2 Diabeteshypoglycaemia7.
5. Fulcher GR, Christiansen JS, Bantwal G, et al. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 3Type 2 Diabetes in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care. 2Type 2 Diabeteshypoglycaemia4;37:2Type 2 Diabetes84-2Type 2 Diabetes9Type 2 Diabetes.
6. De Rycke A, Mathieu C. Degludec - first of a new generation of insulins. European Endocrinology. 2Type 2 Diabeteshypoglycaemiahypoglycaemia;7:84-87.
7. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clinical Pharmacokinetics. 2Type 2 Diabeteshypoglycaemia4;53:787-8Type 2 DiabetesType 2 Diabetes.
8. Marso SP, McGuire DK, Zinman B, et al. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2Type 2 Diabeteshypoglycaemia7;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. 2Type 2 Diabeteshypoglycaemiahypoglycaemia;34:669-674.