Dulaglutide (Trulicity) effectively boosted blood glucose control in youth with type 2 diabetes, the AWARD-PEDS trial found.
Over the 26-week trial, 51% of youth (ages 10 to <18 years) treated with once-weekly dulaglutide achieved an HbA1c below 7% versus 14% on placebo (P<0.001), reported Silva A. Arslanian, MD, of the University of Pittsburgh, and colleagues.
Two doses of the GLP-1 receptor agonist were tested and both were deemed superior at reducing HbA1c versus placebo:
- 0.75-mg group: -0.6% drop
- 1.5-mg group: -0.9% drop
- Placebo: 0.6% increase
As for fasting glucose levels, these increased by 17.1 mg/dL for youth on placebo but dropped by 18.9 mg/dL among all kids on dulaglutide.
The findings were presented at the American Diabetes Association (ADA) annual meeting and simultaneously published in the New England Journal of Medicine.
Cases of type 2 diabetes among US youth have more than doubled since the pandemic, according to an ADA press statement.
“These findings are a potential breakthrough in the pediatric diabetes space and can help address the unmet need for additional treatments available to young people with diabetes, particularly pharmacotherapeutic options,” Arslanian said in the statement. “We are encouraged by the strong HbA1c improvements achieved, and are hopeful that a once-a-weekly medication could be a step forward for how young people are treated.”
The researchers added that the “data from our trial suggest that dulaglutide, if ultimately approved for pediatric use, may offer advantages not only with regard to glycemic control but also with regard to its frequency and method of administration.” Also, because the treatment doesn’t “require reconstitution steps or needle handling,” it will have greater appeal to a pediatric population.
Dulaglutide was FDA approved in 2014 for the treatment of adults with type 2 diabetes. Developer Eli Lilly announced in 2020 that the agent gained an indication to reduce the risk of major adverse cardiovascular (CV) events — CV death, nonfatal myocardial infarction, or nonfatal stroke — in adults with type 2 diabetes mellitus who have established CV disease or multiple CV risk factors.
The injectable is currently available for adults in four doses: 0.75 mg, 1.5 mg, 3.0 mg, and 4.5 mg. Arslanian’s group pointed out that they did not include the two higher doses in this trial because they were not available for use when the trial started. The 3.0-mg and 4.5-mg doses were approved in September 2020.
While there weren’t any significant positive or negative BMI changes seen among the youth in AWARD-PEDS, the same doses in adults have previously demonstrated a body weight loss between 1.4 kg to 3.0 kg (3.1 lb to 6.6 lb) over a 6- to 12-month study period.
As expected with a GLP-1 receptor agonist, more AWARD-PEDS patients on dulaglutide experienced gastrointestinal adverse events, most common of which were diarrhea, vomiting, and nausea. There were no reports of severe hypoglycemia. Arslanian’s group noted that “safety profile of dulaglutide [in AWARD-PEDS] was consistent with that reported in adults.”
A total of 154 patients were included in the trial. The average age at baseline was 14.5 and 71% were female. A total of 55% identified as Hispanic, 15% as Black, 12% as Asian, and 10% as American Indian or Alaska Native. They had a BMI greater than the 85th percentile for age and sex. Teens with type 1 diabetes were excluded from the study.
For those taking metformin with or without basal insulin therapy, the HbA1c had to be between 6.5% to 11%, while those treated with diet and exercise only had to have a level between 6.5% and 9.0%. Those who were on metformin or insulin had to be on stable doses prior to inclusion. The majority of youth were treated with metformin only at baseline.
The trial was funded by Eli Lilly.
Arslanian and co-authors disclosed multiple relationships with industry including Eli Lilly.