Novo Nordisk has announced positive results from a phase 3 trial evaluating semaglutide for the prevention of kidney disease-related events in people with type 2 diabetes and chronic kidney disease (CKD).
Announced in October last year, the kidney outcomes FLOW trial was stopped early due to the efficacy of semaglutide in preventing kidney disease-related incidences.
According to Diabetes UK, out of the 4.9 million people living with diabetes in the UK, 90% have type 2 diabetes.
An estimated 40% of people living with type 1 or type 2 diabetes will go on to develop CKD, a gradual loss of kidney function over time, during their lifetime.
The double-blind trial evaluated injectable semaglutide 1mg in comparison to placebo as a potential alternative standard of care treatment for the prevention of the progression of kidney impairment and the risk of kidney and cardiovascular mortality in 3,533 people with type 2 diabetes and CKD.
Results showed that semaglutide was safe and well-tolerated, and achieved its primary endpoint after demonstrating a statistically significant reduction of 24% in kidney disease progression, cardiovascular and kidney death for people treated with semaglutide.
Martin Holst Lange, executive vice president for development at Novo Nordisk, commented: “The positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and CKD.”
Available under the brand name Ozempic, semaglutide is already approved as an alternative to diet and exercise to improve glycaemic control in adults living with type 2 diabetes while reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease.
The company now intends to file for regulatory approvals of a label expansion for Ozempic in the US and the EU this year and will present detailed results from the FLOW trial at a scientific conference later this year.
In January this year, Novo Nordisk shared positive topline results from the phase 3a COMBINE trial of once-weekly IcoSema, a fixed-ration combination of basal insulin icodec and semaglutide, in type 2 diabetes patients inadequately controlled by daily basal insulin.