About 3 times as many of the children and teenagers taking dulaglutide had a glycated hemoglobin level of less than 7.0% at 26 weeks compared with those on placebo.
Treatment with a once-weekly dose of 0.75 mg or 1.5 mg dulaglutide was better than placebo in improving glycemic control among youths with type 2 diabetes (T2D).
Findings were published earlier this month in New England Journal of Medicine and also presented at the American Diabetes Association (ADA) 2022 Scientific Sessions.
In a double-blind, placebo-controlled, 26-week trial, about 3 times as many participants on dulaglutide had a glycated hemoglobin level of less than 7.0%.
The open-label extension study, Assessment of Weekly Administration of LY2189265 in Diabetes-Pediatric Study (AWARD-PEDS), examined the efficacy and safety of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA). Dulaglutide (Trulicity) has been approved since 2014 for the treatment of adults with T2D.
Researchers randomly assigned 154 participants, aged 10 to 18 years of age, being treated with lifestyle modifications alone or with metformin, with or without basal insulin, in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg. They were also randomized by body mass index (BMI) above the 85th percentile.
The researchers said they aimed to have more diverse participants in this trial, since Black and Hispanic youths have a higher prevalence of T2D. Of the 154% participants, 15% were Black, 55% were Hispanic, 55% were White, 12 were Asian, and 10% were American Indian or Alaska Native.
Among those who underwent randomization, 146 (95%) completed the 26-week double-blind period and 139 (90%) completed the 52-week treatment period.
Following the end of the double-blind period at week 26, those assigned to dulaglutide continued to receive open-label dulaglutide at the assigned dose, while those on placebo began to receive open-label dulaglutide at a weekly dose of 0.75 mg.
The primary end point was the change from baseline in the glycated hemoglobin level at 26 weeks. Secondary end points included a glycated hemoglobin level of less than 7.0% and changes from baseline in the fasting glucose concentration and BMI.
At 26 weeks, the mean glycated hemoglobin level had increased in the placebo group by 0.6 percentage points (estimated treatment difference, -1.4 percentage points; 95% CI, -1.9 to -0.8) and had decreased in the dulaglutide groups (–0.6 percentage points in the 0.75-mg group and −0.9 percentage points in the 1.5-mg group). Both results were statistically significant at P <.001.
At 26 weeks, a higher percentage of participants in the pooled dulaglutide groups than in the placebo group had a glycated hemoglobin level of less than 7.0% (51% vs. 14%; P <.001).
Fasting glucose concentration rose in the placebo group (17.1 mg per deciliter) and dec in the pooled dulaglutide groups (−18.9 mg per deciliter; P <.001), and there were no between-group differences in the change in BMI.
The safety profile of dulaglutide was consistent with what was seen in adults; the incidence of gastrointestinal adverse events was higher with dulaglutide than with placebo.
The once-a-week dosing of dulaglutide, if it is approved for pediatric use, may prove beneficial in this population, the authors noted.
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