91-LB: Once-Weekly Exenatide in Youth with Type 2 Diabetes: A Pivotal Phase III Randomized Study

Abstract

Aim: To evaluate the efficacy and safety of once‑weekly exenatide (EQW) in youth with T2D. Methods: Participants (aged 10 to Results: Overall, 83 participants were randomized (exenatide: 59; placebo: 24); 72 completed 24-week treatment. Baseline characteristics were mostly balanced between groups. At 24 weeks, EQW was superior to placebo in lowering HbA1c; the least squares mean (LSM) change in HbA1c was −0.36% for EQW and +0.49% for placebo (between-group difference: −0.85%; P=0.012). Nonsignificant LSM differences from baseline to 24 weeks favoring EQW were observed for FG (−21.6 mg/dL; 95% CI: −49.0, 5.7; P=0.119), SBP (−2.8 mmHg; 95% CI: −8.0, 2.4; P=0.284), and body weight (−1.22 kg; 95% CI: −3.59, 1.15; P=0.307). EQW was well tolerated; AEs occurred in 61.0% and 73.9% and serious AEs in 3.4% and 4.3% of participants in the EQW and placebo groups, respectively. Conclusion: In youth with T2D sub-optimally controlled with current treatments, EQW was effective in improving metabolic control. EQW was well-tolerated and no AEs led to treatment discontinuation by the investigator. Disclosure W. V. Tamborlane: Consultant; Self; Medtronic, Sanofi, Other Relationship; Self; Tolerion, Inc. C. Sjostrom: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. R. Bishai: Employee; Self; AstraZeneca. D. Geller: None. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Self; Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi. D. Al-abdulrazzaq: None. E. Karoly: None. O. Doehring: Employee; Self; AstraZeneca. D. Carter: Employee; Self; AstraZeneca. J. Monyak: Employee; Self; AstraZeneca.