Young people with T2D are known to have more severe insulin resistance and beta cell dysfunction than their adult counterparts. As a result, the number of pharmacological interventions is limited for young people based on their disease severity and higher side effect profile.
For a paper published in the New England Journal of Medicine, the researchers conduct- ed a phase 3, randomized, placebo-controlled trial that examined the efficacy and safety of dulaglutide, a glucagon-like peptide-1 receptor agonist, in youth with T2D.
The study had a double-blinded period of 26 weeks, followed by 26 weeks of an open-label trial. Young people aged 10 to 17 with a BMI over the 85th percentile for their height and weight and glycated hemoglobin between 6.5% and 11% were included.
No Adverse Events Led to Therapy Discontinuation
The groups examined were placebo (N=51), 0.75 mg (N=51), and 1.5 mg (N=52) weekly. At 26 weeks, the pooled dulaglutide group had a mean glycated hemoglobin 0.8% less than baseline, compared with a 0.6% in- crease in the placebo group (estimated treatment difference, -1.4%; 95% CI, -1.9 to -0.8; P<0.001). Dulaglutide was also superior
to placebo for secondary glycemic endpoints such as a glycated hemoglobin less than 7.0% and change in baseline fasting blood glucose concentration.
For those assigned to placebo group and switched to 0.75 mg treatment, a decrease of 0.9% from baseline mean glycated hemoglobin was seen at 13 weeks after they switched (week 39). No clinically relevant changes in body weight, BMI, or height were observed between the treatment and placebo groups. Adverse events were reported in 69% of the placebo group, 75% in the 0.75 mg dulaglutide group, and 73% in the 1.5mg dulaglutide group at the end of 26 weeks.
No adverse events led to discontinuation of therapy and no deaths were reported during the 52 weeks of the trial. Overall, dulaglutide may represent a treatment for youth with T2D, a group with reduced treatment
Dulaglutide Decreased Glycated Hemoglobin Levels in Youth
Dulaglutide may represent an effective intervention for youth with T2D. The dulaglutide groups had a decreased glycated hemoglobin level at the end of the study, while the placebo group had an increased level. The improvement in the treatment group was seen across subgroups of age, sex, race, ethnic group, diabetes medication use, duration of diabetes, baseline glycated hemoglobin level, BMI, and body weight.
Dulaglutide was not superior to placebo with regards to weight, height, or BMI changes. Gastrointestinal events were the most common side effect, which were more common in the treatment group than in the placebo group. In summary, dulaglutide may offer an advantage to other therapeutics due to its effective glycemic control, frequency, and easier method of administration.
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