Once-weekly treatment with dulaglutide was found to improve glycemic control in adolescents with uncontrolled type 2 diabetes (T2D), according to data presented at the 82nd Scientific Sessions of the American Diabetes Association.
Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently approved by the Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with T2D. The phase 3 AWARD-PEDS study (CinicalTrials.gov Identifier: NCT02963766) was conducted to investigate the safety and efficacy of dulaglutide in pediatric patients ages 10 to less than 18 years with T2D who were treated with lifestyle alone or were on a stable metformin dose with or without basal insulin.
Patients were randomly assigned to receive dulaglutide 0.75mg (n=51), dulaglutide 1.5mg (n=52) or placebo (n=51) once-weekly through subcutaneous administration. The primary endpoint was the change from baseline in hemoglobin A1c (HbA1c) at week 26.
Findings showed that both doses of dulaglutide were superior to placebo in improving glycemic control based on the change in HbA1c; the estimated treatment difference vs placebo was -1.0% (95% CI, -1.7, -0.4; P =.002) for the 0.75mg dose and -1.5% (95% CI, -2.2, -0.9; P <.001) for the 1.5mg dose.
At week 26, 60.0% of the 0.75mg dose group and 53.2% of the 1.5mg dose group had an HbA1c less than 7%, compared with 18.4% of those who received placebo. A significant improvement in fasting blood glucose was also observed with dulaglutide.
Gastrointestinal side effects (nausea, vomiting, diarrhea) were more commonly reported in patients treated with dulaglutide than with placebo; the incidence of these adverse events was comparable to that observed in adult trials.
“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 study investigator Silva Arslanian MD, Richard L. Day-endowed professor of pediatrics, director Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Diabetes and Metabolism, University of Pittsburgh, UPMC Children’s Hospital of Pittsburgh. “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.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
- Once weekly drug helps control pediatric type 2 diabetes. News release. American Diabetes Association. June 4, 2022. Accessed June 6, 2022. https://www.prnewswire.com/news-releases/once-weekly-drug-helps-control-pediatric-type-2-diabetes-301561362.html
- Arslanian S, Cho JI, Hannon TS, et al. Dulaglutide in youth with type 2 diabetes (T2D)—Results of the AWARD-PEDS randomized, placebo-controlled trial. Presented at the 82nd Scientific Sessions of the American Diabetes Association® (ADA) in New Orleans, LA; June 6, 2022; New Orleans, LA.
This article originally appeared on MPR