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Data from the AWARD-PEDS study presented at ADA 2022 suggest once-weekly dulaglutide could improve glycemic control in youth with type 2 diabetes, with a safety profile consistent with that observed in adult patients.
Results of a new study suggest use of dulaglutide could help improve glycemic control in youth with type 2 diabetes.
With rates of type 2 diabetes in youth and adolescents on the rise in recent years, results of the AWARD-PEDS provide insight into the efficacy and safety of GLP-1 receptor agonist use in children, with results demonstrating once-weekly dulaglutide in 0.75 mg or 1.5 mg doses was superior to placebo for improving glycemic control without an effect on BMI through 26 weeks in youth with unmanaged type 2 diabetes treated with or without metformin.
“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 Silva Arslanian, MD, the Richard L. Day-endowed professor of pediatrics at the University of Pittsburgh and director of the Center for Pediatric Research in Obesity and Metabolism in the Division of Pediatric Endocrinology, Diabetes and Metabolism at UPMC Children's Hospital of Pittsburgh, in a statement from the American Diabetes Association (ADA). “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.”
Presented at the ADA 82nd Scientific Sessions, the Assessment of Weekly Administration of LY2189265 in Diabetes-Pediatric Study (AWARD-PEDS) was a phase 3, randomized, placebo-controlled, parallel-group, superiority trial that enrolled patients aged 10 years or older but less than 18 years of age with a BMI in the 85th percentile or greater who were being treated with or without metformin or basal insulins from 46 centers in nine countries. Funded by Eli Lilly and Company, the trial randomized 154 patients in a 1:1:1 ratio to once-weekly subcutaneous injections of dulaglutide 0.75 mg, dulaglutide 1.5 mg, or placebo for 26 weeks. After this 26-week period, study participants were included in a 26-week open-label extension study where patients who had received placebo began receiving dulaglutide at a weekly dose of 0.75 mg.
At baseline study cohort had a mean age of 14.5±2.0 years, a mean BMI of 34.1±8.8 kg/m2, a mean HbA1c of 8.1±1.3%, mean disease duration of 2.0±1.7 years, and 71% were female. All patients who underwent randomization received at least 1 dose of dulaglutide or placebo and were included in the intention-to-treat population. Of the 154 who were randomized, 95% (n=146) completed the 26-week double-blind period and 90% completed the 52-week treatment period.
The primary outcome of interest for the trial was the change in HbA1c from baseline to 26 weeks. Secondary outcomes of interest for the trial included achieving an HbA1c of less than 7.0% and changes from baseline in fasting glucose and BMI.
Upon analysis, results indicated the mean HbA1c level had increased by 0.6 percentage points among the placebo therapy from baseline to 26 weeks and decreased among the dulaglutide groups, with reductions of -0.6 percentage points in the 0.75 mg arm and -0.9 percentage points in the 1.5 mg arm (P <.001 for both comparisons vs placebo). At 26 weeks, a greater proportion of patients receiving dulaglutide achieved an HbA1c level below 7.0% than with placebo therapy, with 51% of the pooled dulaglutide population reaching this mark compared to 14% of patients receiving placebo (P <.001).
Further analysis suggested the fasting glucose concentration decreased by -18.9 mg/dL in the pooled dulaglutide groups but decreased by 17.1 mg/dL among those receiving placebo (P <.001). Investigators also pointed out there were no between-group differences observed for change in BMI. When assessing the safety profile of dulaglutide, investigators found the safety profile was consistent with that reported in adults, with the incidence of gastrointestinal adverse events greater with dulaglutide than placebo.
This study, “Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes,” was presented at ADA 2022 and simultaneously published in the New England Journal of Medicine.