Novo Nordisk Announces IcoSema Weekly Combination Therapy Meets Primary Endpoint in Phase IIIa COMBINE 3 Trial for Type 2 Diabetes

Jan 10, 2024 07:45 CST Updated 07:45

Novo Nordisk

Insulin Developer and Manufacturer

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 has met its primary endpoint.

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

The study results show that once-weekly IcoSema reduces HbA1cThe effect is non-inferior to insulin glargine U100 and insulin aspart. In the overall baseline HbA1cIn the case of 8.30%, the estimated HbA for the once-weekly IcoSema group1cThe reduction was -1.47%, while the estimated HbA for insulin glargine U100 and insulin aspart groups1cThe reduction was -1.40 (estimated treatment difference: -0.06%).

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

In terms of safety,IcoSema GroupThe estimated incidence of severe or clinically significant hypoglycemia (blood glucose below 3.0 mmol/L) is lower than that of insulin glargine U100 and insulin aspart.ElementIn the trial, once-weekly IcoSema demonstrated good safety and tolerability. 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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