Dulaglutide official-source update · version 1
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Official-source update
Reviewed 2026-09-19 · Preserved version 1
A dedicated pediatric trial
FDA’s 2022 review describes study GBGC in 154 participants aged 10–17 with type 2 diabetes. It compared two dulaglutide groups with placebo during a 26-week blinded period, followed by a 26-week open-label period. The extension is not another independent randomized trial. FDA PDF pp. 5, 6 ↗
More findings and the sources behind them
Selected sections of the November 16, 2022 FDA pediatric supplement review, separate from the original adult EMA assessment and later regulatory changes.
The primary result concerned glucose control
The review supports a reduction in HbA1c versus placebo at week 26. Its prose and Table 2 disagree on the pooled point estimate, so this account does not select one silently. The primary endpoint was not weight loss or cardiovascular events. FDA PDF pp. 7, 8 ↗
Safety findings retain the accompanying-treatment context
Gastrointestinal events were the most common treatment-emergent adverse events. FDA observed the greatest hypoglycemia risk among participants also using insulin. This small pediatric program cannot rule out uncommon or longer-term harms. FDA PDF pp. 9, 12 ↗
The recommendation was specific to this supplement
The reviewer supported extending the glycemic-control indication to patients aged ten and older and discharging one pediatric study requirement. A separate requirement covering higher strengths remained outstanding in this November 2022 memo; its present status needs separate verification. FDA PDF pp. 12, 13 ↗
What remains to be checked
- Reconcile the pooled point-estimate discrepancy against the statistical review and trial publication.
- Verify subsequent pediatric requirements and the current product label; the historical memo is not a current prescribing summary.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
FDA Trulicity pediatric supplement S-051 summary review ↗
Source dated 2022-11-16; retrieved 2026-09-19.
- Study GBGC design and population · PDF pp. 5, 6 of 14
- Primary efficacy analysis and Table 2; inconsistent pooled point estimates · PDF pp. 7, 8 of 14
- Safety interpretation and concomitant insulin · PDF pp. 9, 12 of 14
- Review recommendations and outstanding requirement at that date · PDF pp. 12, 13 of 14
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