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

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Author Block: WILLIAM V. TAMBORLANE, RAAFAT BISHAI, DAVID GELLER, NAIM SHEHADEH, DALIA AL-ABDULRAZZAQ, ÉVA KÁROLY, ORLANDO DOEHRING, DEBRA CARTER, JOHN MONYAK, C. DAVID SJÖSTRÖM, New Haven, CT, Gaithersburg, MD, Los Angeles, CA, Haifa, Israel, Kuwait City, Kuwait, Baja, Hungary, Cambridge, United Kingdom, Mölndal, Sweden
Disclosure Block: W.V.Tamborlane: Consultant; Self; Medtronic, Sanofi, Other Relationship; Self; Tolerion, Inc.. C.Sjöström: 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. É.Károly: None. O.Doehring: Employee; Self; AstraZeneca. D.Carter: Employee; Self; AstraZeneca. J.Monyak: Employee; Self; AstraZeneca.
Aim: To evaluate the efficacy and safety of once‑weekly exenatide (EQW) in youth with T2D.
Methods: Participants (aged 10 to <18 years) were randomized (5:2) to EQW 2 mg or placebo. The primary efficacy endpoint was change from baseline in HbA1c at week 24. The secondary efficacy endpoints included changes in fasting glucose (FG), body weight, and systolic blood pressure (SBP). Frequency of adverse events (AEs) was also assessed.
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.