Results of Phase IIIb trial for Ryzodeg offers successful glycaemic control and with fewer injections than a basal bolus regimen- Novo Nordisk
Data presented at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) show that Ryzodeg (insulin degludec/insulin aspart) from Novo Nordisk administered twice daily, provides successful glycaemic control with fewer injections than a basal-bolus regimen.
The study presented at EASD was a 26-week randomised multinational phase IIIb trial, where patients previously treated with basal insulin were randomised to a regimen of either twice daily Ryzodeg, or a basal-bolus regimen of once-daily insulin degludec plus two to four injections of insulin aspart. The study did not meet its primary endpoint of non-inferiority; however, the results showed that HbA1c was reduced for patients on either regimen, to 7.0% and 6.8% respectively, with no significant difference between the two regimens. Patients who received Ryzodeg experienced a numerically lower rate of overall and nocturnal confirmed hypoglycaemic episodes, 19% and 20% less, respectively. They also gained significantly less weight (p<0.05) over the course of the study and used a significantly lower daily insulin dose (12%; p<0.05) versus the basal-bolus regimen.