Once-Weekly Exenatide in Youth With Type 2 Diabetes

Abstract

<p><strong>OBJECTIVE:</strong> Approved treatments for type 2 diabetes in pediatric patients include metformin, liraglutide, and insulin. However, approximately half of the youth fail metformin monotherapy within 1 year, and insulin therapy is associated with challenges. Consequently, the efficacy and safety of once‑weekly injections of exenatide for the treatment of youth with type 2 diabetes was evaluated. </p> <p><strong>RESEARCH DESIGN AND METHODS:</strong> Participants (aged 10 to <18 years) were randomized (5:2) to once‑weekly exenatide 2 mg or placebo, respectively. The primary efficacy endpoint was change in glycated hemoglobin from baseline to week 24. Secondary efficacy endpoints were also evaluated and the frequency of adverse events (AEs) assessed.</p> <p><strong>RESULTS:</strong> 83 participants were randomized (exenatide, 59; placebo, 24) and 72 completed 24-week treatment (exenatide, 49; placebo, 23). At 24 weeks, the least squares mean change in glycated hemoglobin was −0.36% for the exenatide and +0.49% for the placebo groups (between-group difference, −0.85%; 95% CI: −1.51, −0.19; <em>P</em>=0.012). Nonsignificant least squares mean differences from baseline to 24 weeks favoring exenatide were observed: fasting glucose (−21.6 mg/dL; 95% CI: −49.0, 5.7; <em>P</em>=0.119), systolic blood pressure (−2.8 mm Hg; 95% CI: −8.0, 2.4; <em>P</em>=0.284), and body weight (−1.22 kg; 95% CI: −3.59, 1.15; <em>P</em>=0.307). AEs occurred in 36 (61.0%) and 17 (73.9%) participants in the exenatide and placebo groups, respectively.</p> <p><strong>CONCLUSIONS:</strong> In youth with type 2 diabetes sub-optimally controlled with current treatments, once‑weekly exenatide reduced glycated hemoglobin at 24 weeks and was well tolerated. </p>

ISPAD Clinical Practice Consensus Guidelines 2022: Type 2 diabetes in children and adolescents

“…• Recently, extended release exenatide (Bydureon BCise 2 mg) was approved as a once-weekly injection for youth 10-17 years of age based on data from the BCB114 study showing superiority to placebo in lowering HbA1c with a between-group difference of 0.85 percentage points (p = 0.012). 127 • A clinical trial of another weekly GLP-1 receptor agonist (Dulaglutide) at a once-weekly dose of 0.75 mg or 1.5 mg was superior to placebo in improving glycemic control. The HbA1c lowering was À0.6 percentage points in the 0.75-mg group and À0.9…”

“…This glycemic reduction was accompanied by a small decrease in BMI z‐score. Liraglutide (Victoza 0.6–1.8 mg a day) subsequently received approval by the FDA for use in youth 12–17 years of age. Higher dose Liraglutide (Saxenda 3 mg a day) has been approved for use in youth >12 years of age for weight loss. Recently, extended release exenatide (Bydureon BCise 2 mg) was approved as a once‐weekly injection for youth 10–17 years of age based on data from the BCB114 study showing superiority to placebo in lowering HbA1c with a between‐group difference of 0.85 percentage points ( p = 0.012) 127 A clinical trial of another weekly GLP‐1 receptor agonist (Dulaglutide) at a once‐weekly dose of 0.75 mg or 1.5 mg was superior to placebo in improving glycemic control.…”

Effects of once-weekly dulaglutide on juvenile type 2 diabetes mellitus and obesity in Korea: a pilot study

“…Recently, once daily liraglutide and once weekly exenatide injections were approved for adolescent T2DM patients. 9,10) When using the glucagon like peptide (GLP)-1 agonist, the risk of hypoglycemia is very low, and it also has appetite control, weight loss, and glucose control effects. Furthermore, the once-weekly dulaglutide injection, approved in 2014 and widely used for adult diabetes, showed good blood glucose control efficacy, reduced cardiovascular events, and renal complications in adult type 2 diabetes patients.…”