EASD 2022: Dulaglutide in Youth with Type 2 Diabetes: Results of the AWARD-PEDS Randomized, Placebo-Controlled Trial
The abstract presents the results of the Assessment of Weekly Administration of LY2189265 in Diabetes–Pediatric Study (AWARD-PEDS) which aimed to demonstrate the superiority of dulaglutide (pooled doses) versus placebo for HbA1c reduction at 26 weeks.
The AWARD-PEDS was designed to study efficacy and safety of once-weekly GLP-1 receptor agonist dulaglutide in young individuals aged between 10 to 18 years with type 2 diabetes (T2D) who were managed with lifestyle changes alone or on stable metformin with or without basal insulin. The patients were randomized to receive placebo (N=51), dulaglutide 0.75 mg (N=51), or dulaglutide 1.5 mg (N=52). At 26 weeks, a greater number of patients treated with dulaglutide achieve HbA1c <7% and lowering of fasting plasma glucose. There was no change in body mass index values in the dulaglutide group. Although the incidence of adverse events in the dulaglutide group was higher than placebo, it remained comparable to those observed in adults.
The results of the above analysis establish that once-weekly dose of dulaglutide 0.75 mg or 1.5 mg was superior to placebo for improving glycemic control in youth with inadequately controlled T2D treated with or without metformin and/or basal insulin while having a consistent safety profile as observed in adults without an effect on BMI.
Abstract 109, European Association for the Study of Diabetes (EASD) International Congress 2022, 19th – 23rd Sept. 2022, Stockholm
