Weekly dulaglutide lowers glycated hemoglobin in young people with T2DM; no data on clinical outcomes

Reference

Arslanian SA, Hannon T, Zeitler P, et al, for the AWARD-PEDS Investigators. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med 2022;387(5)433-443.

Synopsis

Type 2 diabetes mellitus (T2DM) is increasingly common in adolescents. These industry-funded researchers identified persons aged 10 to 18 years with a body mass index in (at least) the 85th percentile and a glycated hemoglobin (HbA1c) level between 6.5% and 11.0%. The authors randomized 154 participants to receive placebo, weekly subcutaneous (SC) dulaglutide 0.75 mg, or weekly SC dulaglutide 1.5 mg. The groups were similar at baseline, with approximately 60% taking metformin and approximately 25% taking metformin plus basal insulin. The patients took their assigned treatment in double-blind fashion for 26 weeks, followed by a 26-week open-label period. The groups were balanced at baseline: the average age was 14.5 years, 71% were female, 45% were a non-white race, and the mean A1C was 8.1%. At 26 weeks, the mean HbA1c level increased 0.6% in the placebo group, decreased 0.6% in the 0.75-mg group, and decreased 0.9% in the 1.5-mg group. At 52 weeks, more patients in the dulaglutide groups than in the placebo group achieved an HbA1c level of less than 7.0% (51% vs 14%; P < .001; number needed to treat = 3). There was no difference in body mass index among groups, and adverse events (especially gastrointestinal) were more common in the dulaglutide groups. The study was too small and too short to either address either patient-oriented outcomes or rare but potentially serious adverse events. Gastrointestinal symptoms were the most common adverse events.