Youth with type 2 diabetes (T2D) taking the once-weekly GLP-1 receptor agonist (GLP-1 RA) dulaglutide (Trulicity®, Eli Lilly) had a decrease in HbA1c at 26 weeks without a significant change in body mass index (BMI), according to results from the phase 3 AWARD-PEDS clinical trial.
The international study was presented Monday, June 6 at the 82nd Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, LA, and simultaneously published in The New England Journal of Medicine.
“These findings are a potential breakthrough in the pediatric diabetes space and can help address the unmet need for additional treatments available to young people with diabetes, particularly pharmacotherapeutic options,” said presenting author Silva Arslanian, MD, professor of pediatrics, professor of clinical and translational science institute, University of Pittsburgh, School of Medicine, in an ADA press release.
The prevalence of T2D among US young has significantly increased in the past several years, yet there are still limited treatment options for this growing patient population. Researchers sought to evaluate whether a once-weekly subcutaneous injection of dulaglutide, which is already approved for use in adults with the disease, would improve glycemic control in children and adolescents with T2D.
A total of 154 participants (mean age, 14.5 years; mean BMI, 34.1 kg/m2) with T2D treated with lifestyle alone or on a stable dose of metformin with or without basal insulin were enrolled in the study. Participants were randomized in a 1:1:1 ratio to receive once-weekly subcutaneous injections of either placebo (n=51), 0.75 mg dulaglutide (n=51), or 1.5 mg dulaglutide (n=52). The primary endpoint was the change from baseline in the HbA1c level at 26 weeks. Secondary endpoints included a HbA1c level of <7.0% and changes from baseline in fasting glucose concentration and BMI.
Results showed that at 26 weeks, HbA1c decreased 0.6 percentage points in the 0.75 mg dulaglutide group and 0.9 percentage points in the 1.5 mg dulaglutide group (P<.001 for both comparisons vs placebo), while there was a 0.6 percentage point increase in the placebo group. A higher percentage of participants in the pooled dulaglutide groups than in the placebo group had a HbA1c level of <7.0% at 26 weeks (51% vs 14%, P<.001).
The fasting glucose concentration decreased by 18.9 mg/dL in the pooled dulaglutide groups compared with a 17.1 mg/dL increase in the placebo group (P<.001), and there were no between-group differences in the change in BMI. The safety profile of dulaglutide was consistent with that reported in adults, according to investigators.
“We are encouraged by the strong HbA1C improvements achieved, and are hopeful that a once-a-weekly medication could be a step forward for how young people are treated,” added Arslanian.
Reference: Arslanian SA, Hannon T, Zeitler P, et al. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med. Published online June 4, 2022. doi: 10.1056/NEJMoa2204601.