Trial Shows Metformin with Liraglutide Promising for Children with Type 2 Diabetes

August 21, 2019

Metformin as monotherapy is the preferred treatment for children and teens with type 2 diabetes, but a new study published in the Aug. 15 issue of the New England Journal of Medicine suggests that adding liraglutide to the treatment can more effectively control glycemic levels.

Metformin as monotherapy is the preferred treatment for children and teens with type 2 diabetes, but a new study published in the Aug. 15 issue of the New England Journal of Medicine suggests that adding liraglutide to the treatment can more effectively control glycemic levels.

"In children and adolescents with type 2 diabetes, liraglutide, at a dose of 1.8 mg per day (added to metformin, with or without basal insulin), was efficacious in improving glycemic control over 52 weeks," wrote authors who were led by William V. Tamborlane, M.D., of Yale University.

This was a double-blind, randomized phase three four year long trial of 134 (mean age 14.6 years) patients between the ages of 10 and 17 years who did not have an adequate response to metformin with or without insulin. Of these, 66 received a single daily dose of up to 1.8 mg liraglutide (with or without basal insulin) in addition to metformin while 68 received placebo.

By week 26 of the trial, called The Evaluation of Liraglutide in Pediatrics with Diabetes (Ellipse), "the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of −1.06 percentage points (P<0.001); the difference increased to −1.30 percentagae points by 52 weeks."

Fasting plasma glucose levels decreased in the treatment group, but increased in the placebo group.

Of concern with this study were the prevelance of mild gastrointestinal adverse events effecting as many as 84.8 percent of patients in the treatment group.

Controlling type 2 diabetes in children and adolescents is concerning because the condition is on the rise, partly due to the inrease of obesity in children. And, although, metformin is the current treatment of choice, it doesn't always work. When metformin fails, insulin is the only other option for children and teens. No new treatment for type 2 diabetes has been approved for children since metformin in 1999.

REFERENCE

William V. Tamborlane, M.D., Margarita Barrientos-Pérez, M.M.S.C.I., Udi Fainberg, M.D., et al. "Liraglutide in Children and Adolescents with Type 2 Diabetes,"New England Journal of Medicine. Aug. 15, 2019. DOI: 10.1056/NEJMoa1903822