Novo Nordisk joins UCB and gets knocked down by its drug’s final clinical trial. Liraglutide, the already approved adjunct therapy for people with type 2 diabetes won’t reach out to type 1 diabetes.
Novo Nordisk can look at a 90-year long history of improving the lives of diabetes patients. However, the phase IIIa trial that tested several doses of liraglutide as an ‘add-on’ to insulin treatment was a lead balloon.
Liraglutide is a once-daily human analog of the naturally occurring hormone Glucagon-Like Peptide-1. It stimulates the release of insulin only when glucose levels become too high, suppressing the glucagon production by the liver and by inhibiting appetite. The compound is approved for the treatment of type 2 diabetes, and Novo hoped to expand its application to patients suffering from type 1 diabetes.
The liraglutide molecule. © Novo Nordisk
But no chance, the results are disappointing. Only two out of three doses reached the primary objective. They improved HbA1c – a value to measure the blood glucose level – only by about 0.5% compared with 0.3% for people treated with placebo. Further, the drug didn’t show the hypoglycemic benefit that was experienced in type 2 diabetes.
The most common adverse effects were related to the gastrointestinal system and consisted mainly of vomiting. This may contribute to the fact that liraglutide leads to weight loss, which is untypical for antidiabetic treatments. Patients treated with liraglutide lost between 3 kg and 4 kg, whereas the placebo group increased in weight by about 1kg.
Based on these results, Novo won’t submit an application for liraglutide’s use in type 1 diabetes. This implies that the Danish company misses the chance to bring back the spent money, which must be quite a bit. For this phase IIIa only, 1,398 people were treated once-daily for 52 weeks.
Plus, the drug had the potential to really improve its finances. The sales of liraglutide for type 2 diabetes were increased by 41% in the first year of 2015, bolstering Novo’s revenues significantly.
All in all, the results are a real damper for Novo’s rise, which showed great numbers for the first semester. However, the company is still the world’s leading insulin supplier and will surely recover soon from this disappointment.