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Novo Nordisk announced that it will not pursue an expanded indication for liraglutide (Victoza) as an add-on treatment to insulin for type 1 diabetes because of disappointing phase III trial results.
The company for the randomized trial, in which nearly 1,400 people with type 1 diabetes were treated for 52 weeks with either placebo and insulin or with insulin and liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist.
The liraglutide-insulin combination had little effect on HbA1c levels (mean baseline of about 8.2%). Specifically, those treated with 1.2 mg and 1.8 mg of liraglutide saw an improvement of around 0.5% versus 0.3% for those on placebo. However, the company stated that liraglutide as adjunct to insulin therapy "achieved the primary objective of non-inferiority in HbA1c."
The rate of severe hypoglycemia was not significantly different for the treatment and placebo groups. In addition, those treated with 1.2 and 1.8 mg of liraglutide had a significantly higher rate of confirmed symptomatic hypoglycemia, according to the company.
The findings were in contrast to data from the SCALE study, which showed that a 1.8 mg dose of liraglutide improved both HbA1c and fasting glucose in patients with type 1 diabetes compared to placebo.
"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," said , executive vice president and chief science officer for .
"Novo Nordisk intends to conduct thorough analyses to evaluate the clinical data and define potential future clinical and regulatory initiatives," according to the company.