Friday, 8 December 2017

Ryzodeg lowers hypoglycaemia risk during Ramadhan

The drug Ryzodeg (insulin degludec/insulin aspart in a 70/30 ratio) has 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]) in a trial targeted at people with type 2 diabetes who fast during Ramadhan. Both drugs are made by 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 Ramadhan and four weeks post-Ramadhan. There was no difference in overall blood sugar control between Ryzodeg and BIAsp 30*.

The 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 Ramadhan. 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 Ramadhan (four-week period). Secondary confirmatory endpoints included rates of blood sugar confirmed, nocturnal and severe hypoglycaemia.

"Millions of people with type 2 diabetes participate in Ramadhan 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 Ramadhan 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 Ramadhan**. Muslims with type 2 diabetes who fast during Ramadhan have up to a 7.5-fold increased risk of severe hypoglycaemia***.

"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 Ramadhan," said Mads Krogsgaard Thomsen, Executive VP and Chief Science Officer of Novo Nordisk.

Ryzodeg is 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****, *****, ******, given as an injection once or twice daily with the main meals****.  It is commercially available in 13 countries****.

*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.

**International Diabetes Federation and the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical Guidelines. Brussels, Belgium: International Diabetes Federation, 2016. Available at: . Last accessed: November 2017.

***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.

****EMA. Ryzodeg Summary of Product Characteristics. Last accessed: November 2017.

*****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.

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