There’s a new drug on the horizon for children with diabetes, based on results of a long-awaited clinical trial. Liraglutide, an injectable drug, is currently approved for use in adults only but recently proved effective in controlling blood sugar in children with a few noted side effects.
Known as the Ellipse trial (Evaluation of Liraglutide in Pediatrics with Diabetes), this study tested the drug in children between the ages of 10 and 17. The goal was determining whether adding the injectable drug to current therapy helps achieve target blood sugar levels in children.
Liraglutide was approved in 2010 for the treatment of diabetes in adults. It helps promote blood sugar control and reduce cardiovascular risk in adults with type 2 diabetes. However, its effect in children with type 2 diabetes requires further investigation.
Based on results of the Ellipse trial, which were published in the New England Journal of Medicine, findings appear promising. The study included a total of 135 children with type 2 diabetes who were unable to achieve target blood sugar control with metformin.
Metformin is considered standard therapy for children with type 2 diabetes but doesn’t always work at regulating blood sugar, especially as children age.
The study was conducted at 84 sites in 25 countries. Participants were 15 years old, on average, and all were overweight or obese based on their height and weight.
During the one-year study, participants were randomly chosen to receive liraglutide or an inactive placebo drug, in addition to metformin. Researchers closely tracked participants’ blood sugar levels as well as any adverse events that occurred throughout the trial.
After analysis, researchers found that participants taking liraglutide plus metformin had significantly lower blood sugar levels by the end of the study compared to those taking metformin only. They were also more likely to achieve target blood sugar control than those on standard therapy.
Overall, authors note that the number of patients experiencing adverse events were similar in both study groups. While no events were considered serious, liraglutide was associated with increased risk for adverse events—especially nausea.
Based on findings, authors conclude that liraglutide plus metformin helps improve blood sugar control in children with type 2 diabetes. However, the drug may have unwanted gastrointestinal effects, which is important to consider when weighing potential treatments.
While liraglutide has yet to be approved by the U.S. Food and Drug Administration for use in children, experts are encouraged by findings. Rates of type 2 diabetes are at an all-time high and continue to increase among children, largely due to childhood obesity. Experts hope the addition of liraglutide to approved therapies could help children achieve better control of their blood sugar and diabetes.