Trulicity Approval Status for Pediatric Patients
Yes, Trulicity (dulaglutide) is FDA-approved for use in patients aged 10 to less than 18 years old with type 2 diabetes. 1
FDA Approval and Clinical Evidence
Dulaglutide received FDA approval for pediatric use based on the AWARD-PEDS trial, which demonstrated superiority over placebo in youths aged 10 to <18 years with type 2 diabetes. 1
The pivotal trial showed that dulaglutide at doses of 0.75 mg or 1.5 mg once weekly significantly reduced glycated hemoglobin levels compared to placebo (-0.6 and -0.9 percentage points respectively vs. +0.6 percentage points with placebo, P<0.001). 1
At 26 weeks, 51% of participants receiving dulaglutide achieved a glycated hemoglobin level below 7.0% compared to only 14% with placebo (P<0.001). 1
Current Guideline Recommendations
The American Diabetes Association recognizes only four FDA-approved medication classes for youth with type 2 diabetes: insulin, metformin, GLP-1 receptor agonists (specifically liraglutide and dulaglutide), and SGLT2 inhibitors. 2
Important Distinction from Liraglutide
While earlier ADA guidelines (2020-2021) specifically mentioned only liraglutide for patients aged 10 years and older, 3 dulaglutide has since been added to the approved options following the completion of the AWARD-PEDS trial. 1
The 2020-2021 ADA guidelines explicitly stated that "use of medications not approved by the U.S. Food and Drug Administration for youth with type 2 diabetes is not recommended outside of research trials," 3 which underscores the importance of dulaglutide's subsequent FDA approval for this age group.
Clinical Positioning
Dulaglutide should be considered when glycemic targets are not met with metformin alone (with or without basal insulin) in patients 10 years of age or older. 2
The medication demonstrated a safety profile in youths consistent with that reported in adults, with gastrointestinal adverse events being the most common side effects. 1
Key Contraindications
- Dulaglutide is contraindicated in patients with personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 2