Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes

This phase 3, randomized, placebo controlled trial evaluated the efficacy and safety of once weekly dulaglutide (0.75 mg or 1.5 mg) in youths aged 10 to <18 years with type 2 diabetes. Participants (N=154) were randomized to dulaglutide or placebo for 26 weeks, followed by a 26 week open label extension. The primary endpoint was the change in glycated hemoglobin (HbA1c) at 26 weeks. Results showed significant reductions in HbA1c with dulaglutide (0.6 to 0.9 percentage points) compared to an increase with placebo (+0.6 percentage points; P<0.001). A higher percentage of dulaglutide treated participants achieved HbA1c <7.0% (51% vs. 14% with placebo, P<0.001). Fasting glucose also improved, but no significant BMI changes were observed. Gastrointestinal adverse events were more common with dulaglutide. The study concluded that dulaglutide is superior to placebo in improving glycemic control in youths with type 2 diabetes, with a safety profile consistent with adult data.

This phase 3, randomized, placebo controlled trial evaluated the efficacy and safety of once weekly dulaglutide (0.75 mg or 1.5 mg) in youths aged 10 to <18 years with type 2 diabetes. Participants (N=154) were randomized to dulaglutide or placebo for 26 weeks, followed by a 26 week open label extension. The primary endpoint was the change in glycated hemoglobin (HbA1c) at 26 weeks. Results showed significant reductions in HbA1c with dulaglutide (0.6 to 0.9 percentage points) compared to an increase with placebo (+0.6 percentage points; P<0.001). A higher percentage of dulaglutide treated participants achieved HbA1c <7.0% (51% vs. 14% with placebo, P<0.001). Fasting glucose also improved, but no significant BMI changes were observed. Gastrointestinal adverse events were more common with dulaglutide. The study concluded that dulaglutide is superior to placebo in improving glycemic control in youths with type 2 diabetes, with a safety profile consistent with adult data.