Positive phase 3 for Novo Nordisk combination diabetes drug
Novo Nordisk has announced that a phase 3 clinical trial of its diabetes drug, Ryzodeg, showed improved control of blood sugar levels compared to biphasic insulin aspart 30 (NovoMix® 30).
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,”
Lead investigator Gregory Fulcher, Royal North Shore Hospital, Sydney, Australia.
Data presented at the World Diabetes Congress of the International Diabetes Federation (IDF) showed that 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 with Ryzodeg compared to biphasic insulin as part 30, both administered twice-daily.
Ryzodeg has been approved in Japan, Mexico, EU, Norway, Iceland, Switzerland, El Salvador and Chile.
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