A higher percentage of participants in the pooled dulaglutide group had a glycated hemoglobin level of <7.0% than the placebo group at week 26 of the AWARD-PEDS trial.
According to new findings presented at the American Diabetes Association (ADA) 2022 Scientific Sessions, treatment with a once-weekly dose of 0.75 mg or 1.5 mg dulaglutide was superior to placebo in improving glycemic control among youths with type 2 diabetes (T2D).
Through 26 weeks, investigators observed approximately 3 times as many participants in the dulaglutide groups in comparison to the placebo group had a glycated hemoglobin level of less than 7.0%.
“The data from our trial suggest that dulaglutide, if ultimately approved for pediatric use, may offer advantages not only with regard to glycemic control but also with regard to its frequency and method of administration,” wrote study author Silva A. Arslanian, MD, Division of Pediatric Endocrinology, Diabetes, and Metabolism, University of Pittsburgh, School of Medicine, UPMC Children’s Hospital of Pittsburgh.
These findings were the results of the randomized, double-blind Assessment of Weekly Administration of LY2189265 in Diabetes-Pediatric Study (AWARD-PEDS) assessing the efficacy and safety of the once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), dulaglutide.
Investigators noted participants aged 10 to 18 years of age with body mass index (BMI) greater than the 85th percentile for age and sex being treated with lifestyle modifications alone or with metformin, with or wihtout basal insulin, were randomized 1:1:1 to receive once-weekly subcutaneous injections of placeo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
Following the end of the double-blind period (week 26), those assigned to dulaglutide continued to receive open-label dulaglutide at the assigned dose, while those assigned to placebo began to receive open-label dulaglutide at a weekly dose of 0.75 mg.
The primary efficacy endpoint was identified as the change in the glycated hemoglobin level from baseline to week 26. Key secondary endpoints included a glycated hemoglobin level of ≤7.0% and changes from baseline in the fasting plasma glucose concentration and in the BMI. Safety was additionally assessed, according to investigators.
From a total of 227 youth with diabetes assessed for eligibility between December 2016 - December 2020, 154 underwent randomization. Among those who underwent randomization, 146 (95%) completed the 26-week double-blind period and 139 (90%) completed the 52-week treatment period.
According to the intention-to-treat estimand, the mean glycated hemoglobin level at week 26 decreased from baseline by 0.8 percentage points in the pooled dulaglutide group, but sa an increase by 0.6 percentage points in the placebo group (estimated treatment difference, -1.4 percentage points; 95% confidence interval [CI], -1.9 to -0.8; P <.001).
Investigators noted superiority in the primary end-point analysis of the change in the glycated hemoglobin level was shown with each dulaglutide dose (0.75 mg per week and 1.5 mg per week) compared with placebo (P <.001).
Data show at 26 weeks, a higher percentage of those in the pooled dulaglutide group had a glycated hemoglobin level of <7.0% compared to placebo (51% vs 14%, P <.001). Moreover, the fasting glucose concentration increased in the placebo group (17.1 mg per deciliter) and decreased in the pooled dulaglutide groups (-18.9 mg per deciliter, P <.001). There were no between group-differences in the change in BMI.
In terms of body-weight end points, dulaglutide was not superior to placebo regarding the lowering of BMI and there were no clinically relevant differences across the trial groups in the change from baseline in BMI through 52 weeks.
Meanwhile, no adverse events leading to treatment discontinuation were found during the open-label period through 52 weeks and no deaths were reported during the trial. They noted gastrointestinal event incidence was higher with dulaglutide therapy than placebo through 26 weeks. The overall safety profile of dulaglutide was consistent with previous reports in adults.
The study, “Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes,” was published in The New England Journal of Medicine.