Novo Nordisk has announced the results of a Phase III diabetes trial in which its Victoza (liraglutide) injection was found to hit both its primary and secondary endpoints, reducing A1C - the amount of haemoglobin in the blood that has glucose attached to it - at both 26 weeks and 52 weeks.
The results showed that the safety profile of Victoza seen in children and adolescents was similar to that seen in adults.
In the trial, the percentage of children who reported an adverse event was similar in both groups with headache, nasopharyngitis, dizziness and gastroenteritis in the top adverse reactions.
The ELLIPSE trial is the first Phase III trial completed in over a decade in children and adolescents with type II diabetes, despite the prevalence of type II diabetes in children and adolescents ever-increasing.
The problem is “driven by the global epidemic of childhood obesity, yet our treatment options are limited," said Dr William Tamborlane, professor and chief of endocrinology, Yale School of Medicine and ELLIPSE lead investigator. "These data represent a potential new treatment option for lowering blood sugar in children and adolescents with type II diabetes."
The human glucagon-like peptide-1 (GLP-1) receptor is approved in Europe for the treatment of adults with insufficiently controlled type 2 diabetes together with diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other diabetes treatments.