Oral Semaglutide Shows Superior Glycaemic Control<\/p>\n
The phase 3a study evaluated oral semaglutide in patients aged 10\u201317 years and found the drug delivered a superior reduction in HbA1c (blood sugar levels) compared to placebo.<\/p>\n
The trial demonstrated<\/a> a statistically significant and superior reduction in blood sugar by 0.83% versus placebo at 26 weeks.<\/p>\n The treatment also demonstrated a safety profile consistent with prior semaglutide trials, reinforcing its tolerability.<\/p>\n Oral semaglutide is currently marketed as Rybelsus in the U.S. and Europe.<\/p>\n Novo Nordisk expects to file for regulatory approval of a label expansion for Ozempic pill and Rybelsus in the U.S. and EU in the second half of the year.<\/p>\n Rising Burden Of Youth-Onset Type 2 Diabetes<\/p>\n The prevalence of type 2 diabetes<\/a> among children and adolescents has increased significantly over the past two decades, creating a substantial unmet medical need. The condition is associated with higher risks of early mortality later in life.<\/p>\n Globally, an estimated 14.6 million adolescents were living with type 2 diabetes in 2021, a figure projected to rise to 20.9 million by 2030.<\/p>\n Limitations Of Current Treatment Options<\/p>\n Current treatment guidelines recommend metformin and insulin as first-line therapies. <\/p>\n However, metformin fails to maintain glycaemic control in roughly half of adolescent patients, while insulin use is linked to risks such as hypoglycemia and weight gain<\/a>.<\/p>\n The PIONEER TEENS trial represents the first clinical evaluation of an oral GLP-1 receptor agonist in this age group. <\/p>\n Pending regulatory approvals, oral semaglutide could become the first oral therapy in this class to show superior efficacy over placebo in pediatric patients.<\/p>\n Trial Design And Key Details<\/p>\n The 52-week study enrolled 132 participants and tested multiple dose levels of oral semaglutide against a placebo. Patients received background therapy with metformin, basal insulin, or both<\/a>.<\/p>\n NVO Stock Price Activity: Novo Nordisk shares were down 0.05% at $39.13 during premarket trading on Thursday, according to Benzinga Pro data<\/a>.<\/p>\n Image via Shutterstock<\/p>\n