Liraglutide pharmacokinetics and exposure-response in pediatric patients with type 2 diabetes.

Objectives Based on the ellipse trial, liraglutide was recently approved for use in pediatric patients with type 2 diabetes. We report the comparative exposure of liraglutide in pediatric vs. adult patients. Methods In this pharmacokinetic (PK) and exposure-response meta-analysis, data from two pediatric trials (including ellipse) and two adult trials of liraglutide were compiled (1,137 PK observations from 116 patients) to determine the impact of body weight, age and sex on liraglutide exposure. The exposure-response relationship for glycated hemoglobin (HbA1c) and body weight was compared between pediatric and adult patients. Additionally, the relationships between exposure and change from baseline in body mass index (BMI) and BMI standard deviation score (SDS) were assessed. Results The same liraglutide dose showed comparable exposure levels in pediatric and adult patients. Body weight and sex were the most important covariates for liraglutide exposure. There was an increasing response with higher liraglutide concentrations, and greater reductions were observed from baseline in HbA1c at 26 weeks vs. placebo. A trend toward lower body weight, BMI and BMI SDS was observed at 26 weeks. Conclusions These results support use of the same liraglutide dosing regimen in children and adolescents, aged ≥10 years, as that used in adults.