Dulaglutide improves blood sugar control in young people with type 2 diabetes: Study
USA: Treatment with dulaglutide effectively enhances blood sugar control in youth with type 2 diabetes who were being treated with or without metformin or basal insulin, according to findings from the AWARD-PEDS trial.
The study found that treatment with dulaglutide at a once-weekly dose of 0.75 mg or 1.5 mg is superior to placebo for improving glycemic control through 26 weeks without an effect on BMI. The study findings were presented at the American Diabetes Association (ADA) and subsequently published in The New England Journal of Medicine.
There is an increasing incidence of type 2 diabetes among youths. In some studies, once-weekly treatment with dulaglutide, a glucagon-like peptide-1 receptor agonist, was shown to be effective with regard to glycemic control in youth with type 2 diabetes.
Against the above background, Silva A. Arslanian and the team conducted a double-blind, placebo-controlled, 26-week trial. The study included participants aged 10 to <18 years; body-mass index [BMI], >85th percentile who were being treated with lifestyle modifications alone or with metformin, with or without basal insulin.
154 participants were randomly assigned in a ratio of 1:1 to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg. Participants were then included in a 26-week open-label extension study in which those who had received a placebo began receiving dulaglutide at a weekly dose of 0.75 mg.
The change from baseline in the glycated hemoglobin level at 26 weeks was the primary endpoint. Secondary endpoints included a glycated hemoglobin level of less than 7.0% and changes from baseline in the fasting glucose concentration and BMI. A safety assessment was also done.
Salient findings include:
- At 26 weeks, the mean glycated hemoglobin level had increased in the placebo group (0.6 percentage points) and had decreased in the dulaglutide groups (–0.6 percentage points in the 0.75-mg group and −0.9 percentage points in the 1.5-mg group for both comparisons vs. placebo).
- At 26 weeks, a higher percentage of participants in the pooled dulaglutide groups than in the placebo group had a glycated hemoglobin level of less than 7.0% (51% vs. 14%).
- The fasting glucose concentration increased in the placebo group (17.1 mg per deciliter) and decreased in the pooled dulaglutide groups (−18.9 mg per deciliter), and there were no between-group differences in the change in BMI.
- The incidence of gastrointestinal adverse events was higher with dulaglutide therapy than with placebo.
- The safety profile of dulaglutide was consistent with that reported in adults.
"Dulaglutide treatment at a once-weekly dose of 0.75 mg or 1.5 mg was superior to placebo in improving glycemic control through 26 weeks among youths with type 2 diabetes who were being treated with or without metformin or basal insulin, without an effect on BMI," wrote the authors.
