VIENNA – A novel fixed-dose insulin analogue combination reduced blood glucose levels to a similar degree as a control basal-bolus regimen in patients with type 2 diabetes but just failed to show noninferiority for the primary endpoint in a phase IIIb randomized trial.
The percentage change in hemoglobin A1c from baseline to week 26 was –1.3% for IDegAsp (Ryzodeg, Novo Nordisk) and –1.5% for the basal-bolus regimen used as the comparator.
IDegAsp is a soluble combination of 70% insulin degludec (Tresiba, Novo Nordisk) and 30% insulin aspart (NovoLog, Novo Nordisk). Unlike other fixed-dose insulins, IDeg and IAsp exist separately in a coformulation.
Although noninferiority was not demonstrated for glycemic control, there was a significant benefit in terms of a lower dose of insulin used (1.11 vs. 1.34 U) and less weight gain, of about 1 kg, with IDegAsp than with the basal-bolus approach. There were also numerically lower rates of confirmed (rate ratio, 0.81) and nocturnal hypoglycemia (RR, 0.80). Both regimens were well tolerated.
“If we are very, very, strict, and as we did not reach noninferiority, we can’t really say anything about anything else,” study investigator Dr. John Cooper of Stavanger (Norway) University Hospital conceded in an interview at the annual meeting of the European Association for the Study of Diabetes. He added, however, “common sense says that it is very close and it looks like it is a useful insulin.”