AWARD-PEDS was a Phase 3 trial to assess the efficacy and safety of dulaglutide (DU) , a once-weekly GLP-1 receptor agonist, in youth (10 to <18 years old) with T2D treated with lifestyle alone or on stable metformin with or without basal insulin. Participants (mean age, 14.5 yrs; mean BMI, 34.1 kg/m2) were randomized to placebo (N=51) , DU 0.75 mg (N=51) , or DU 1.5 mg (N=52) . The primary aim was to demonstrate superiority of DU (pooled doses) vs. placebo for change in HbA1c at 26 weeks. Analyses included all patients with ≥1 dose of study drug, excluding data after initiation of rescue therapy. DU was superior to placebo (figure) in improving glycemic control measured by change in HbA1c, percent of patients with HbA1c <7%, and change in fasting glucose at Week 26. No effect of DU was observed on BMI change (p=0.776) . Fewer patients assigned to DU compared to placebo required rescue therapy (2.9% vs. 17.6% respectively, p=0.003) . Incidence of common GI adverse events was higher in DU group vs. placebo [nausea (14.6% vs. 7.8%) , vomiting (15.5% vs. 3.9%) , diarrhea (18.4% vs. 13.7%) ] but comparable to that observed in adults.
In conclusion, in youth with inadequately controlled T2D treated with or without metformin and/or basal insulin, once weekly DU 0.75 mg or 1.5 mg was superior to placebo in improving glycemic control without an effect on BMI through 26 weeks, with a safety profile consistent with that established in adults.
S. A. Arslanian: Advisory Panel; Eli Lilly and Company, Novo Nordisk. Research Support; Eli Lilly and Company, Novo Nordisk. Other Relationship; AstraZeneca. J. Cho: None. T. S. Hannon: Advisory Panel; Eli Lilly and Company. P. Zeitler: Consultant; Boehringer Ingelheim International GmbH, Daiichi Sankyo, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Takeda Pharmaceutical Company Limited. L. Chao: None. M. Barrientos: Research Support; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Research & Development, LLC, Novo Nordisk. C. C. Boucher-Berry: None. E. Bismuth: None. S. A. Dib: None. D. Cox: Employee; Eli Lilly and Company.
Eli Lilly and Company