A study evaluating exenatide extended-release in adolescents with type 2 diabetes met its primary endpoint of significant reduction in HbA1c from baseline when compared with placebo.
The phase 3, double-blind, placebo-controlled, parallel trial (ClinicalTrials.gov Identifier: NCT01554618) was designed to investigate the effects of once-weekly exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, on glycemic control in patients 10 to 17 years of age. Participants were administered subcutaneous exenatide 2mg or placebo once weekly.
At week 24, the least squares mean change from baseline HbA1c in the treatment group was -0.36% compared with +0.49% for the placebo group, making the LS mean difference -0.85% (P =.012). The proportion of patients who met the secondary endpoint of HbA1c of less than 7.0% was significantly higher in the treatment group vs placebo group (31% vs 8.3%; P =.02). Other secondary endpoints (ie, changes in fasting glucose and body weight) favored exenatide but were nonsignificant.
The most common adverse event in the treatment group was upper respiratory tract infections (10%). Overall, the safety profile in the adolescent population was found to be consistent with that observed in the adult population.
Exenatide extended-release (Bydureon) is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The FDA has granted Priority Review to AstraZeneca for its supplemental New Drug Application for use of the treatment in those aged 10 to 17 years old.
“The rise in frequency of [type 2 diabetes] in pediatric patients corresponds to the international epidemic of childhood obesity, resulting in increased insulin resistance and beta cell disfunction in adolescents,” said William Tamborlane, MD, Department of Pediatrics, Yale School of Medicine and international coordinating investigator of the adolescent trial. “It is particularly noteworthy that no once weekly injection of a GLP-1 receptor agonist has been approved for older children or adolescents with T2D by the US Food and Drug Administration. Consequently, once weekly injections of exenatide could fill that gap in treatment options for T2D patients in this age group.”
Phase III pivotal trial of once weekly exenatide in adolescents aged 10–17 shows benefit for the treatment of type 2 diabetes. [press release]. Wilmington, Delaware: AstraZeneca; June 25, 2021.
This article originally appeared on MPR