Clinical Trials

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 glucoselowering 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.

According to the company’s press release, ‘COMBINE 3 is the first trial to readout in the phase 3a COMBINE programme, and results from COMBINE 1 and COMBINE 2 will be shared later this year’.

Martin Holst Lange, executive vice president for Development at Novo Nordisk, commented: “We are very pleased to share the first phase 3a results for onceweekly 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.”