Novo Nordisk Announces Positive Topline Results from Phase IIIa COMBINE 3 Trial of Once-Weekly IcoSema in Type 2 Diabetes

On January 8, Novo Nordisk announced that the Phase IIIa trial (COMBINE 3) of once-weekly IcoSema (a fixed-ratio combination of basal insulin icodec and semaglutide) vs basal insulin in the treatment of type 2 diabetes had met its primary endpoint.

COMBINE 3 is a 52-week, open-label, treat-to-target trial that compared the efficacy and safety of once-weekly IcoSema with once-daily insulin glargine U100 and insulin aspart (administered 2-4 times daily at mealtimes) in 679 patients with type 2 diabetes who had inadequate glycemic control on once-daily basal insulin, with or without concomitant oral antidiabetic drugs.

The study results showed that once-weekly IcoSema was non-inferior to insulin glargine U100 and insulin aspart in lowering HbA1c. With an overall baseline HbA1c of 8.30%, the estimated HbA1c reduction in the once-weekly IcoSema group was -1.47%, compared to -1.40% in the insulin glargine U100 and insulin aspart group (estimated treatment difference: -0.06%).

Moreover, based on a baseline weight of 85.8 kg, patients receiving IcoSema experienced significant weight loss, with an estimated weight reduction of 3.6 kg in the IcoSema group, compared to a weight increase of 3.2 kg in the insulin glargine U100 and insulin aspart groups (estimated treatment difference: -6.7 kg).

In terms of safety, the estimated incidence of severe or clinically significant hypoglycemia (blood glucose below 3.0 mmol/L) was lower in the IcoSema group compared to insulin glargine U100 and insulin aspart. Additionally, once-weekly IcoSema demonstrated good safety and tolerability in this trial. The most common adverse events reported by patients were gastrointestinal adverse events, consistent with GLP-1 receptor agonist drugs, and the vast majority were mild to moderate.

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