Novo Nordisk has announced the first results of a Phase 3a trial comparing the efficacy and safety of IcoSema once-weekly with insulin glargine U100 and insulin aspart (injected 2 to 4 times a day with meals) in 679 people with type 2 diabetes inadequately controlled by daily basal insulin.

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

From an overall baseline HbA1c of 8.30%, IcoSema once weekly achieved an estimated HbA1c reduction of -1.47 percentage points, compared with -1.40 percentage points for insulin glargine U100 and insulin aspart.

In the trial, IcoSema was superior to insulin glargine U100 and insulin aspart in terms of estimated rates of severe or clinically significant hypoglycemia.

These results demonstrate the potential of IcoSema with just one injection per week, compared with around 28 injections per week for people with type 2 diabetes inadequately controlled by basal insulin," said Martin Holst Lange, Executive Vice President Development at Novo Nordisk.


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