Ryzodeg significantly reduces the risk of low blood sugar in people with type 2 diabetes who fast during Ramadan, by 62%
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).
In people with type 2 diabetes who fast during Ramadan, Ryzodeg (insulin degludec and 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]).
It is estimated that worldwide over 116 million Muslims with diabetes may choose to fast during Ramadan. Muslims with type 2 diabetes who fast during Ramadan 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 Ramadan," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The Ramadan trial compared the efficacy and safety of Ryzodeg庐 twice daily and BIAsp 30 (NovoMix庐) 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.
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 available in 13 countries.
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