Once-Weekly Exenatide in Youth With Type 2 Diabetes
OBJECTIVE: 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.
RESEARCH DESIGN AND METHODS: 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.
RESULTS: 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; P=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; P=0.119), systolic blood pressure (−2.8 mm Hg; 95% CI: −8.0, 2.4; P=0.284), and body weight (−1.22 kg; 95% CI: −3.59, 1.15; P=0.307). AEs occurred in 36 (61.0%) and 17 (73.9%) participants in the exenatide and placebo groups, respectively.
CONCLUSIONS: 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.