Findings from an international study show a once-weekly injection of dulaglutide was superior in improving glycemic control in youth with type 2 diabetes compared to placebo. The trial was presented 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. 

The findings come at a time when cases of type 2 diabetes among youth have more than doubled, since the pandemic. Currently, there are limited treatment options for youth with diabetes, despite being a growing and progressive condition. This study sought to evaluate if a once-weekly subcutaneous injection of GLP-1 receptor agonist, dulaglutide—a drug that is approved in adults—would improve glycemic control in youth with type 2 diabetes. 

The study enrolled 154 patients between the ages of 10 and 18 (mean age, 14.5 years; mean BMI, 34.1 kg/m2) with type 2 diabetes treated with lifestyle alone or on stable metformin with or without basal insulin. Patients were randomized to placebo (N=51), 0.75 mg dose of dulaglutide (N=51), or 1.5 mg dose of dulaglutide (N=52). The primary endpoint was to demonstrate superiority of dulaglutide (pooled doses) versus placebo for change in A1C (a strong indicator of blood glucose levels) at 26 weeks.

Findings show that in youth with unmanaged type 2 diabetes treated with or without metformin and/or basal insulin, a once weekly 0.75 mg or 1.5 mg dose of dulaglutide was superior to placebo in improving glycemic control without an effect on BMI through 26 weeks. The safety of the therapy was consistent with the safety profile established in adults taking dulaglutide. 

“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, 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.”