Novo Nordisk does not plan to expand Victoza (liraglutide) for use in type 1 diabetes after disappointing results from a recent study.
In the pharmaceutical company’s latest phase III trial, Victoza – a GLP-1 analogue which is used to treat type 2 diabetes – was used as an add-on treatment to insulin in type 1 patients.
1,400 people were recruited for a year-long trial. Alongside insulin treatment, they were either given one of three liraglutide doses via once-daily subcutaneous injectio, or placebo.
The trial, known as ADJUNCT ONE, could have allowed liraglutide to be used in type 1 treatment as well as type 2, but the study reported negative findings.
Those treated with the two highest doses of liraglutide (1.2mg and 1.8mg) had significantly higher rates of symptomatic hypoglycemia. While these doses performed better than placebo in reducing HbA1c, and enabled greater weight loss, the lowest dose (0.6mg) performed worse than placebo.
These findings were in contrast to Novo Nordisk’s 2014 SCALE study, in which a 1.8mg dose of liraglutide met HbA1c targets without increasing episodes of hypoglycemia.
Earlier this month, another phase III study called ADJUNCT TWO was also conducted, but neither trial has led to liraglutide being further considered as a type 1 treatment.
In a statement, Novo Nordisk announced: “Based on a risk/benefit assessment of the overall dataset from the two ADJUNCT trials, Novo Nordisk does currently not intend to submit an application to expand the label of Victoza for use in type 1 diabetes.”
Mads Krogsgaard Thomse, executive vice president and chief science officer for Novo Nordisk, added: “We are disappointed, as we believed in the potential to provide people with type 1 diabetes with a new treatment option. We will continue to invest in new treatment options for this group of people.”
