BALTIMORE, April 28, 2019 /PRNewswire/ -- Novo Nordisk today announced the results from the ELLIPSE trial which examined efficacy and safety and demonstrated superiority of Victoza® (liraglutide) injection 1.8 mg vs placebo in reducing blood sugar in children and adolescents aged 10-17 with type 2 diabetes.1 ELLIPSE is the first phase 3 trial completed in over a decade in children and adolescents with type 2 diabetes. These data were presented today 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.2 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.
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).2 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<0.001.2
"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 US 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.
"We are delighted with the ELLIPSE trial results and look forward to discussions with the FDA and EMA about these data for Victoza®," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "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."
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%).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®.2
Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is a human glucagon-like peptide-1 (GLP-1) receptor agonist that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve glycemic control and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. In Europe, approved in 2009, Victoza® is indicated 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 medicinal products for the treatment of diabetes. Victoza® is commercially available in more than 100 countries, treating more than 1.2 million people with type 2 diabetes globally.3
ELLIPSE (NCT01541215) is a phase 3, multicenter trial in which 135 children 10-17 years of age were randomized 1:1 to treatment with Victoza® (liraglutide) up to 1.8 mg/day or placebo, in combination with metformin, with or without basal insulin, for a 26-week, double-blind period, followed by a 26-week open label extension for collection of additional data (total 52 weeks), as well as an additional 52 week off-treatment safety follow-up for people treated for more than 3 months with liraglutide.4
About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.
- Tamborlane WV, et al. Liraglutide in Children and Adolescents with Type 2 Diabetes. NEJM 2019 ePub ahead of print.
- Tamborlane WV, et al. The efficacy and safety of liraglutide versus placebo in children and adolescents with type 2 diabetes: the Ellipse randomized trial results. Abstract no. 617. Poster presented at the Pediatric Academic Societies / Pediatric Endocrine Society Pediatric Meeting in Baltimore, US. 2019.
- Internal calculations derived from IMS data from IQVIA; IMS Midas February 2018.
- ClinicalTrials.gov. Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (Ellipse™). Available at: https://clinicaltrials.gov/ct2/show/NCT01541215. Last accessed: March 2019.
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