Novo Nordisk shares positive results from COMBINE 3 phase 3a trial

Betsy Goodfellow | January 10, 2024 | News story | Research and Development Diabetes, IcoSema, Novo Nordisk, clinical trial, diabetes 

Novo Nordisk has shared topline results from the COMBINE 3 phase 3a trial of once-weeklly IcoSema, a fixed-ration combination treatment consisting of basal insulin icodec and semaglutide.

The trial was a 52-week, open-label treat-to-target trial which assessed the efficacy and safety of once-weekly IcoSema compared to once-daily insulin glargine U100 and insulin aspart (injected 2-4 times each day during mealtimes), dosed with or without oral glucose-lowering medications. The trial included 679 people with type 2 diabetes inadequately controlled currently being treated with daily basal insulin.

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

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Martin Holst Lange, executive vice president for Development at Novo Nordisk, commented: “We are very pleased to share the first phase 3a results for once-weekly IcoSema. The results demonstrate the potential of IcoSema to simplify insulin intensification by reducing the injection burden to a single injection per week compared to around 28 injections per week for people with type 2 diabetes inadequately controlled on basal insulin while providing glycaemic control as well as weight benefits and lower rates of hypoglycaemia.”

Betsy Goodfellow

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