Adults with type 2 diabetes achieved improved glycaemic control, significantly lower rates of overall and nocturnal confirmed hypoglycaemia for the full trial period, and a significantly lower rate of severe hypoglycaemia during the maintenance period (defined as week 16 onwards) with Ryzodeg compared to biphasic insulin aspart 30, both administered twice-daily, according to a data presented at the World Diabetes Congress of the International Diabetes Federation (IDF).
Ryzodeg is the first combination of two distinct insulin analogues, Tresiba (insulin degludec), the once-daily basal insulin with an ultra-long duration of action, and the well-established mealtime insulin NovoRapid (insulin aspart), in the ratio of 70% and 30%, in one pen for people with type 2 diabetes.
“Type 2 diabetes is a progressive disease and many patients who are uncontrolled with basal insulin need to add mealtime insulin to achieve or maintain their glycaemic targets over time. As Ryzodeg is a combination of two distinct insulins, a basal insulin with a long and steady action profile and a well-established mealtime insulin, it is a simple way for patients to add mealtime control with a reduced risk of overall and nocturnal confirmed, and severe hypoglycaemia,” said lead investigator Gregory Fulcher, Royal North Shore Hospital, Sydney, Australia.
The multinational BOOST INTENSIFY PREMIX I trial was a 26-week, randomised, controlled open-label, treat-to-target trial comparing the efficacy and safety of Ryzodeg and biphasic insulin aspart 30, both administered twice-daily with or without oral anti-diabetic drugs in adult patients with type 2 diabetes previously treated with premixed or self-mixed insulin either once- or twice-daily.
Ryzodeg is the global brand name for insulin degludec/insulin aspart. It is a combination of two distinct insulin analogues, Tresiba (insulin degludec) and NovoRapid (insulin aspart) in the ratio of 70% and 30%. Ryzodeg delivered twice-daily at main meals offers successful reductions in HbA1c2 with lower rates of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes. Ryzodeg has been approved in Japan, Mexico, EU, Norway, Iceland, Switzerland, El Salvador and Chile.
Novo Nordisk completed the phase 3a BOOST programme in 2010. This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries and comprised the majority of the data supporting the regulatory applications for Ryzodeg. More than 2000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe and USA.
Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care.