1/1
2 files

Once-Weekly Exenatide in Youth With Type 2 Diabetes

figure
posted on 09.06.2022, 15:48 authored by William V. Tamborlane, Raafat Bishai, David Geller, Naim Shehadeh, Dalia Al-Abdulrazzaq, Evelina Mánica Vazquez, Eva Karoly, Tünde Troja, Orlando Doehring, Debra Carter, John Monyak, C. David Sjöström

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. 

Funding

AstraZeneca funded the study and was involved in the development of the study design, data collection, data analysis, data interpretation, writing the article, and the decision to submit the article for publication.

History