Novo Nordisk's COMBINE3 Phase 3 Trial Reveals Positive Results For Once-weekly IcoSema In Diabetes

(RTTNews) - Novo Nordisk (NVO) Monday announced positive results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide in inadequately controlled type 2 diabetes.

The company said the trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.

COMBINE 3 was a 52-week, open-label treat-to-target trial of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart, dosed with or without oral glucose-lowering medications, in 679 people.

The study showed that an overall baseline HbA1c of 8.30, once-weekly IcoSema achieved an estimated reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin aspart.

The trial also revealed a weight reduction of -3.6 kg, from a baseline body weight of 85.8 kg, with IcoSema and a weight gain of 3.2 kg with insulin glargine U100 and insulin aspart.

Once-weekly IcoSema appeared to have a safe and well-tolerated profile, the company noted.