Results of a recently completed clinical trial of a potential drug to treat Type 2 diabetes in children were announced Sunday  at the Pediatric Academic Societies 2019 meeting in Baltimore, Md. The New England Journal of Medicine also published the findings. Study coauthor Jane Lynch, M.D., FAAP, professor of pediatrics at UT Health San Antonio, said the drug, liraglutide, in combination with an existing medication, metformin, showed robust effect in treating children studied in the Ellipse trial.

Effect in treating children

Currently only two drugs, metformin and insulin, are approve by the U.S. Food and Drug Administration for the treatment of Type 2 diabetes in children. By comparison, more than 30 drugs are approved to treat this form of diabetes in adults. Because “We’ve not been able to get drugs approved for children beyond metformin and insulin,” Dr. Lynch said.

“This adult diabetes medication was very effective in our trial of youth with Type 2 diabetes and is well tolerate. We urgently need other options for medical treatment of Type 2 diabetes in our youth under age 18. Because If approve, this drug would be a fantastic new option to complement oral metformin therapy as an alternative to insulin for our youth and adolescents with Type 2 diabetes.”

Oral metformin therapy

In San Antonio, Ellipse participants are seen at the Children’s Center at Texas Diabetes Institute, a partnership between UT Health San Antonio and University Health System on San Antonio’s predominantly Hispanic West Side. More than 1,000 children have been diagnose with Type 2 diabetes at the Texas Diabetes Institute since 2005. The youngest is 5 years old. Hispanics and other minorities are at higher risk of developing Type 2 diabetes.

The Ellipse study compared outcomes of 66 children who received liraglutide shots plus metformin pills for 26 weeks with the outcomes of 68 other children who received metformin and a placebo. Because Children age 10-17 were eligible for the study. Therefore  The study was a randomized; parallel-group, placebo-controlled trial–the gold standard for clinical research studies. For 26 weeks, it was double-blind neither the participating families nor the investigators knew which children were receiving liraglutide versus placebo.

Hemoglobin level

All children received metformin therapy for the duration, along with rescue insulin if need, and diet and exercise counseling. After 26 weeks; the study continued as an open-label trial with children who receive liraglutide continuing to do so and those on placebo stopping the placebo and continuing on metformin with rescue insulin as needed.
Investigators measured the children’s glycated hemoglobin level (commonly called “A1C”) at baseline; at week 26 and at week 52. The change in A1C from baseline to week 26 was the study’s primary endpoint. In the liraglutide group at week 26; mean A1C levels are reduce from baseline by 0.64%; whereas levels increase by 0.42% in the placebo group.