Novo Nordisk's GLP-1 Receptor Agonist Victoza (Liraglutide) Achieves Success in Pediatric Phase III Trial for Type 2 Diabetes

April 29, 2019/BioValleyBIOON/--DiabetesNovo Nordisk recently announced the results of the Phase III clinical study ELL for Victoza (liraglutide) at the annual meeting of the Pediatric Endocrine Society (PES)/Pediatric Academic Societies (PAS) held in Baltimore, Maryland, USA.ipsData on E.

It is worth mentioning that this study is the past 10 years in type 2DiabetesThe first Phase III study completed in the pediatric and adolescent (aged 10–17 years) patient population evaluated the efficacy and safety of Victoza (1.8 mg dose) versus placebo, with data confirming the superiority of Victoza over placebo in lowering blood glucose levels.

Currently, Victoza is indicated as an adjunct to diet and exercise to improve type 2DiabetesBlood Glucose Control in Adult Patients. ELLipsStudy E aims to evaluate the clinical application of Victoza in pediatric and adolescent patients.

ELLipsStudy E included a 26-week double-blind treatment period, followed by a 26-week open-label extension period. The study results demonstrated that when added to metformin (with or without basal insulin therapy), Victoza significantly reduced A1c compared with placebo at both 26 weeks (primary endpoint) and 52 weeks (secondary endpoint), with reductions of -0.64% and -0.50%, respectively, whereas placebo resulted in increases in A1c of +0.42% and +0.80% at 26 and 52 weeks, respectively. Furthermore, the proportion of patients achieving an A1c <7% at Week 26 (secondary endpoint) was significantly higher in the Victoza group (63.7%) than in the placebo group (36.5%), with the difference being statistically significant (p<0.001).

Overall, Victoza in type 2DiabetesThe safety profile in pediatric and adolescent patients was similar to that in adult patients. In the study, the proportion of patients reporting adverse events (AEs) was similar between the two groups (84.8% in the Victoza group vs. 80.9% in the placebo group). GastrointestinalAdverse ReactionsThe incidence rate was higher than that in the placebo group (13.2%). Adverse events with an incidence ≥5% in the Victoza group included headache, nasopharyngitis, dizziness, gastroenteritis, upper respiratory tract infection, rash, fever, and decreased appetite. Mild hypoglycemia occurred in 24.2% of patients treated with Victoza, compared to 10.3% in the placebo group. No cases of severe hypoglycemia were reported among patients treated with Victoza.

From ELLipsThe results of Study E have been submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to evaluate Victoza as a potential treatment option for pediatric and adolescent patients aged 10 years and older with type 2 diabetes.

Dr. William Tamborlane, Professor and Chief of Endocrinology at Yale School of Medicine and Principal Investigator of the ELLIPSE study, stated, “The prevalence of type 2 diabetes in children and adolescents is rising, driven by the global epidemic of childhood obesity, yet our treatment options are limited. Data from ELLips“These data from the E study provide a new therapeutic option for lowering blood glucose in children and adolescents with type 2 diabetes.”

Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer at Novo Nordisk, stated, “We are excited about ELLipspleased with the results of Study E, and look forward toFDADiscussions with the EMA regarding these data on Victoza. These data provide extensive evidence supporting the use of Victoza, further reinforcing Novo Nordisk’s commitment to addressing the substantial and growing unmet medical needs across the entire population of patients with type 2 diabetes.”

Victoza (liraglutide) is a blockbuster antidiabetic drug from Novo Nordisk. Its active pharmaceutical ingredient, liraglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist that stimulates the secretion of endogenous insulin. In clinical studies, liraglutide not only significantly improves glycemic control but also effectivelyWeight Lossand improve obesity-related comorbidities. Based on this finding, Novo Nordisk has developed liraglutide into aWeight LossSaxenda injection (liraglutide, 3 mg). To date, Victoza has been approved in more than 100 countries worldwide, with over 1.2 million patients with type 2 diabetes treated. (Bioon.com)

Original Source:Victoza demonstrated superiority in reducing blood sugar vs placebo in children and adolescents with type 2 diabetes