DENMARK – Novo Nordisk has completed its COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide.

In a press statement, Novo Nordisk confirmed that the objective of the trial is to assess the efficacy and safety of IcoSema in around 1.300 people with type 2 diabetes inadequately controlled on basal insulin treatment.

Once-weekly IcoSema is fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide. In the COMBINE 3 phase 3a trial, once-weekly IcoSema appeared to have a safe and well-tolerated profile,” said Novo Nordisk.

The global healthcare company further said that the COMBINE 3 phase 3a trial involved 679 people with type 2 diabetes inadequately controlled on daily basal insulin treatment.

However, the most common adverse events for people treated with IcoSema were gastrointestinal consistent with GLP-1 receptor agonist class and the vast majority were mild to moderate.

Initiated in the second quarter of 2022, the COMBINE 3 phase 3a trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.

COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart, dosed with or without oral glucose-lowering medications,” reported Novo Nordisk.

It is worth highlighting that once-weekly IcoSema is being evaluated in the phase 3a COMBINE programme, which consists of three, multinational, multicentre, randomised, parallel-group, open-label, treat-to target trials.

In the clinical trial, IcoSema was superior to insulin glargine U100 and insulin aspart in estimated rates of severe or clinically significant (blood glucose below 3.0 mmol/L) hypoglycaemia.

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, according to Novo Nordisk.

This development highlights the company’s commitment to pioneering scientific breakthroughs, expanding access to its medicines, and working to prevent and ultimately cure disease.

On the phase 3a results for once-weekly IcoSema, Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, highlighted: “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.”

Martin Holst Lange pointed out that once-weekly IcoSema is well placed to provide glycaemic control as well as weight benefits and lower rates of hypoglycaemia for people with type 2 diabetes.

Additional details also include 0.26 events per patient-year of exposure for once-weekly IcoSema and 2.18 events per patient-year of exposure for insulin glargine U100 and insulin aspart.

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

In addition to reduction in HbA1c, from a baseline body weight of 85.8 kg, people treated with IcoSema achieved a superior reduction in estimated change of body weight a weight loss of -3.6 kg with IcoSema and a weight gain of 3.2 kg with insulin glargine U100 and insulin aspart.

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