MONDAY, April 29, 2019 (Pharmacist's Briefing) -- The addition of liraglutide to metformin is effective and safe for children and adolescents with type 2 diabetes, according to a study published online April 28 in the New England Journal of Medicine to coincide with the annual meeting of the Pediatric Academic Societies, held from April 24 to May 1 in Baltimore.
William V. Tamborlane, M.D., from Yale University in New Haven, Connecticut, and colleagues randomly assigned patients aged 10 to <17 years to receive either subcutaneous liraglutide (66 patients) or placebo (68 patients) for a 26-week double-blind period, followed by a 26-week open-label extension period. During the trial, all patients received metformin.
The researchers found that the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo at the 26-week efficacy analysis, for a difference of −1.06 percentage points (P < 0.001); this difference increased to −1.30 percentage points by 52 weeks. In the liraglutide group, the fasting plasma glucose level had decreased at both time points, while the level increased in the placebo group. A similar percentage of patients reported adverse events (84.8 and 80.9 percent with liraglutide and placebo, respectively); the liraglutide group had a higher rate of adverse events and gastrointestinal adverse events.
"The current study showed the superiority of liraglutide to placebo, when added to metformin, with or without basal insulin, with respect to glycemic control in children and adolescents," the authors write.
The study was funded by Novo Nordisk, which manufactures liraglutide.