1. Dulaglutide significantly reduced baseline glycated hemoglobin levels as compared to a placebo control in youth with type 2 diabetes (T2DM).
2. Dulaglutide use was not significantly associated with changes in body mass index (BMI), body weight, or height.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Youth with T2DM 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 youth based on their disease severity and higher side effect profile. Dulaglutide, a glucagon-like peptide-1 receptor agonist delivered subcutaneously once weekly may represent an effective intervention for youth with T2DM. In the present study, youth with T2DM were randomized to receive either dulaglutide or a placebo control. 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.
Click to read the study in NEJM
Relevant Reading: Long-term complications in youth-onset type 2 diabetes
In-Depth [randomized control trial]: This phase three, randomized, placebo-controlled trial examined the efficacy and safety of dulaglutide in youth with T2DM. The study had a double-blinded period of 26 weeks, followed by 26 weeks of an open-label trial. Youth aged 10 to 17 with a BMI of over the 85th percentile for their height and weight, and glycated hemoglobin between 6.5% and 11% were included. 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 percent less than baseline, compared to a 0.6 increase in the placebo group (estimated treatment difference, -1.4%; 95 confidence interval [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 T2DM, a group with reduced treatment options.
Image: PD
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