Insulin maker, Novo Nordisk announced this week the results of a clinical trial which demonstrated the superiority of Victoza® (liraglutide) injection 1.8 mg versus placebo in reducing blood sugar in children and adolescents aged 10-17 with Type 2 diabetes.
The trial, known as ELLIPSE is the first phase 3 trial completed in over a decade in children and adolescents with Type 2 diabetes, according to the company.
Victoza is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. This study was designed to evaluate the investigational use of Victoza in children and adolescents.
How was the Study Conducted?
The ELLIPSE trial included a 26-week, double-blinded treatment period followed by a 26-week open-label extension period.
The trial results showed that, when added to metformin, with or without concurrent basal insulin treatment, Victoza 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).
Additionally, the proportion of children and adolescents achieving A1C <7% at week 26 (secondary endpoint) was significantly higher in those treated with Victoza (63.7%) than in those treated with placebo (36.5%), p<0.001.
“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. “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 U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for evaluation as a potential treatment option for children 10 years and above with Type 2 diabetes.
The data were presented at the Pediatric Endocrine Society (PES)/Pediatric Academic Societies (PAS) Annual Meeting in Baltimore, MD and simultaneously published in the New England Journal of Medicine.
Mads Krogsgaard Thomsen, executive vice president, and chief science officer of Novo Nordisk said the company is delighted with the ELLIPSE trial results and look forward to discussions with the FDA and EMA about these data for Victoza.
“These data add to the extensive evidence for the use of Victoza and further cement Novo Nordisk’s commitment to addressing a considerable and growing unmet medical need across the full spectrum of the Type 2 diabetes patient population,” Thomsen said.
Overall, 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 (AE) was similar in both groups (84.8% with Victoza vs 80.9% with placebo).
Gastrointestinal AEs occurred more frequently with Victoza (33.3%) than placebo (13.2%).
Adverse events greater than or equal to 5% in patients treated with Victoza include headache, nasopharyngitis, dizziness, gastroenteritis, upper respiratory tract infection, rash, pyrexia, and decreased appetite.
Minor hypoglycemia occurred in 24.2% of patients treated with Victoza vs 10.3% in the placebo arm. There were no episodes of severe hypoglycemia in patients treated with Victoza.
- Novo Nordisk.Victoza® demonstrated superiority in reducing blood sugar vs placebo in children and adolescents with type 2 diabetes. PR Newswire. (2019, April 28). Retrieved: https://prnmedia.prnewswire.com/news-releases/victoza-demonstrated-superiority-in-reducing-blood-sugar-vs-placebo-in-children-and-adolescents-with-type-2-diabetes-300839462.html