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Trulicity ® (dulaglutide)
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Can Trulicity® (dulaglutide) be used in the pediatric and adolescent population?
Dulaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adult and pediatric patients 10 years and older with type 2 diabetes.
AWARD-PEDS
AWARD-PEDS was a phase 3, randomized, placebo-controlled study that assessed the efficacy and safety of dulaglutide 0.75 mg and 1.5 mg in pediatric patients, ages 10 to less than 18 years old, with inadequately controlled type 2 diabetes despite diet and exercise, with or without metformin and/or basal insulin.1
The primary endpoint of AWARD-PEDS was to show superiority of dulaglutide (0.75 mg and 1.5 mg, pooled doses) versus placebo for change in glycated hemoglobin (HbA1c) at 26 weeks.1
Key inclusion criteria for AWARD-PEDS is displayed in .1
Patient Population |
Diagnosis |
Current Therapy |
Baseline HbA1c |
Children 10-17 y of age |
Type 2 diabetes |
Diet and exercise with or without metformin and/or basal insulin at stable doses for at least 8 weeks |
>6.5% and ≤11% |
Newly diagnosed and not on any medication |
>6.5% and ≤9% |
Abbreviations: AWARD-PEDS = Assessment of Weekly AdministRation of LY2189265 in Diabetes – PEDiatric Study; HbA1c = glycated hemoglobin.
Reference
1Arslanian SA, Hannon T, Zeitler P, et al; AWARD-PEDS Investigators. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med. 2022;387(5):433-443. https://doi.org/10.1056/NEJMoa2204601
Date of Last Review: 02 June 2022