Study Shows Drug May Be New Treatment Option for Pediatric Patients with T2D
Novo Nordisk announced the results of the ELLIPSE trial, which examined efficacy and safety and demonstrated superiority of liraglutide (Victoza) injection 1.8 mg vs placebo, in a presentation at the Pediatric Endocrine Society (PES)/Pediatric Academic Societies (PAS) Annual Meeting in Baltimore, MD, on Sunday.
A clinical trial has demonstrated that Novo Nordisk’s liraglutide (Victoza) injection significantly reduced blood sugar in children and adolescents aged 10-17 years with type 2 diabetes (T2D).
Novo Nordisk announced the results of the ELLIPSE trial, which examined efficacy and safety, and demonstrated superiority of liraglutide injection 1.8 mg vs placebo, in a presentation at the Pediatric Endocrine Society (PES)/Pediatric Academic Societies (PAS) Annual Meeting in Baltimore, MD, on Sunday.
The ELLIPSE trial included a 26-week, double-blinded treatment period followed by a 26-week open-label extension period. The trial data showed that, when added to metformin, with or without concurrent basal insulin treatment, liraglutide significantly reduced A1C at both 26 weeks (primary endpoint) and 52 weeks (secondary endpoint), -0.64% and -0.50% respectively, versus placebo, where there was an increase in A1C at both 26 weeks and 52 weeks, +0.42% and +0.80% respectively (p<0.001 for both).2 Additionally, the proportion of children and adolescents achieving A1C <7% at week 26 (secondary endpoint) was significantly higher in those treated with liraglutide (63.7%) than in those treated with placebo (36.5%), p<0.001.
ELLIPSE is the first phase 3 trial completed in over a decade in children and adolescents with type 2 diabetes. This study was designed to evaluate the investigational use of the liraglutide, a human glucagon-like peptide-1 (GLP-1) receptor agonist, in children and adolescents. The drug is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
"The prevalence of type 2 diabetes in children and adolescents is increasing, 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, in a prepared statement. "These data represent a potential new treatment option for lowering blood sugar in children and adolescents with type 2 diabetes."
The results of the ELLIPSE trial have been submitted to the FDA and the European Medicines Agency (EMA) for evaluation as a potential treatment option for children age 10 years and older with T2D.
Overall, the safety profile of liraglutide seen in children and adolescents was similar to that seen in adults. In the trial, the percentage of children who reported an adverse event (AE) was similar in both groups (84.8% with liraglutide vs 80.9% with placebo). Gastrointestinal AEs occurred more frequently with liraglutide (33.3%) than placebo (13.2%). Adverse events greater than or equal to 5% in patients treated with liraglutide include headache, nasopharyngitis, dizziness, gastroenteritis, upper respiratory tract infection, rash, pyrexia and decreased appetite. Minor hypoglycemia occurred in 24.2% of patients treated with liraglutide vs 10.3% in the placebo arm. There were no episodes of severe hypoglycemia in patients treated with liraglutide.
Victoza® demonstrated superiority in reducing blood sugar vs placebo in children and adolescents with type 2 diabetes [news release]. Baltimore, MD; April 28, 2019: Novo Nordisk. https://www.novonordisk-us.com/media/news-releases.html?122961. Accessed April 29, 2019.