The company said that the trial failed to 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.
Ryzodeg is a combination of two distinct insulin analogues including insulin degludec and insulin aspart in the ratio of 70% and 30%.
In the trial, patients previously treated with basal insulin were randomized 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.
Study principal investigator and endocrinologist in Rockville Helena Rodbard said patients currently using basal-bolus regimens may need to take up to four daily injections, which can be a great burden and very inconvenient.
"Ryzodeg is a new treatment option which provides proven glycaemic control, with fewer injections and reduced rates of hypoglycaemia compared to basal-bolus regimens," Rodbard said.
"This new treatment offers the potential for a simple alternative to basal-bolus for patients who require intensification of basal insulin regimens."