New research indicates dulaglutide is effective in improving glycemic control in pediatric patients with diabetes.
A once-weekly injection of dulaglutide (Trulicity) was superior in improving glycemic control in youth with type 2 diabetes (T2D) compared to placebo, according to a new study.
Silva Arslanian M.D., scientific director and principal investigator at the UPMC Children's Hospital of Pittsburgh in Pennsylvania, presented the findings of the international trial at the 82nd Scientific Sessions of the American Diabetes Association® (ADA) in New Orleans, Louisiana, June 3-7.1
The research, funded by Lilly, Trulicity’s manufacturer, was simultaneously published in The New England Journal of Medicine.2
“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,” Arslanian said in an ADA news release.3 “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.”
The trial enrolled 154 patients between the ages of 10 and 18 years with T2D treated with lifestyle alone or on stable metformin with or without basal insulin. Patients were randomized to placebo, 0.75 mg dose of dulaglutide, or 1.5 mg dose of dulaglutide.
The researchers found that 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 body mass index through 26 weeks. In addition, the safety of the therapy was consistent with the safety profile established in adults taking dulaglutide.
"Type 2 diabetes in youth is challenging to manage, with few approved treatment options," said Mike Mason, president of Lilly Diabetes, in a news release.4
In the United States, minority populations have among the highest prevalence of youth-onset T2D in the world, Mason added. “Given this, we made an intentional effort to recruit and enroll populations commonly under-represented in clinical trials. The unmet need for effective yet convenient treatments for youth with T2D is substantial and we look forward to sharing these results with regulatory authorities as we pursue a potential new indication for Trulicity."
1.Dulaglutide in youth with Type 2 Diabetes (T2D)—Results of the AWARD-PEDS randomized, placebo-controlled trial. Poster presentation. 82nd Scientific Sessions of the American Diabetes Association® (ADA). June 6, 2022. Accessed June 24, 2022.
2. Arslanian SA, Hannon T, Zeitler P, et. al. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med. 2022 Jun 4. Online ahead of print. doi: 10.1056/NEJMoa2204601.
3. Once weekly drug helps control pediatric type 2 diabetes. News release. ADA. June 4, 2022. Accessed June 24, 2022. https://www.diabetes.org/newsroom/press-releases/2022/once-weekly-drug-helps-control-pediatric-type-2-diabetes
4. Lilly's AWARD-PEDS trial investigating use of Trulicity® (dulaglutide) in youth and adolescents with type 2 diabetes showed superiority in A1C reduction vs placebo. News release. Lilly. June 4, 2022. Accessed June 24, 2022. https://investor.lilly.com/news-releases/news-release-details/lillys-award-peds-trial-investigating-use-trulicityr-dulaglutide