The 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.
Scientists have successfully completed clinical trials of a novel drug to treat Type 2 diabetes in children. Currently only two drugs, metformin and insulin, are approved by the US 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.
“We’ve not been able to get drugs approved for children beyond metformin and insulin,” said Jane Lynch, from the University of Texas in the US. “This adult diabetes medication was very effective in our trial of youth with Type 2 diabetes and was well tolerated. We urgently need other options for medical treatment of Type 2 diabetes in our youth under age 18,” Lynch said in a statement. “If approved, 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,” she said.
The 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. Researchers 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 were reduced from baseline by 0.64 per cent, whereas levels increased by 0.42 per cent in the placebo group. The estimated treatment difference on A1C levels was minus 1.06 per cent, which “showed the superiority of liraglutide to placebo,” the researchers wrote.