Novo Nordisk has been forced to scrap plans to expand its licence for Victoza to include adults with type 1 diabetes following disappointing results in a Phase III study.
The Danish firm had hoped to grow its diabetes market share by extending the label of Victoza (liraglutide) for use in type 1 diabetes.
But the headline results from the company’s second and final Phase IIIa trial, which looked at three different doses of Victoza added to insulin or placebo in 1,400 people with type 1 diabetes who were treated for one year, have forced it to ditch its plans.
The trial’s primary endpoint was to show that Victoza added to insulin is as good as insulin alone at controlling blood sugar levels, (measured as HbA1c). From an average baseline HbA1c of around 8.2%, people treated with 1.2 mg and 1.8 mg Victoza and insulin achieved the primary objective of non-inferiority in blood glucose levels. They showed a greater improvement in HbA1c, of around 0.5%, compared with 0.3% for people treated with placebo.
Furthermore, from an average baseline weight of around 86 kg, people treated with 1.2 mg and 1.8 mg liraglutide and insulin achieved a statistically significantly greater weight loss between 3 kg and 4kg, compared with 1kg in the placebo group.
However the primary objective was not achieved by people who were treated with the 0.6 mg dose. Furthermore, the rate at which people experienced confirmed episodes of low blood sugar levels (hypoglycaemia) was statistically higher with liraglutide 1.2 mg and 1.8 mg, compared with placebo.
An earlier trial to demonstrate Victoza added to insulin is better than insulin alone did meet its primary endpoint for all doses. But there was a higher rate of symptomatic hypoglycaemia was in people treated with liraglutide 1.2 mg compared to placebo.
In a statement the company says: “Based on a risk/benefit assessment of the overall dataset from the two trials, Novo Nordisk does currently not intend to submit an application to expand the label of Victoza for use in type 1 diabetes. Novo Nordisk intends to conduct thorough analyses to evaluate the clinical data and define potential future clinical and regulatory initiatives.”
While Mads Krogsgaard Thomsen, who is executive vice president and chief science officer of Novo Nordisk, adds: “The results of the two trials show that liraglutide as adjunct to insulin therapy met the primary end-point of improving blood glucose control for people with type 1 diabetes, however, unfortunately without the hypoglycaemic benefit experienced in type 2 diabetes. We are disappointed as we believed in the potential to provide people with type 1 diabetes with a new treatment option, and we will continue to invest in new treatment options for this group of people.”