Abstract
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 26weeks vs. placebo. A trend toward lower body weight, BMI and BMI SDS was observed at 26weeks. Conclusions These results support use of the same liraglutide dosing regimen in children and adolescents, aged≥10 years, as that used in adults.
Highlights
The prevalence of type 2 diabetes (T2D) in children and adolescents is increasing, and until recently, the only approved treatments in this population were insulin and metformin
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
Summary
The prevalence of type 2 diabetes (T2D) in children and adolescents is increasing, and until recently, the only approved treatments in this population were insulin and metformin. The glucagon-like peptide-1 analog liraglutide was recently approved for pediatric patients with T2D aged ≥10 years, based on the phase 3 randomized, placebocontrolled ellipse trial (NCT01541215) [1] results, which demonstrated that liraglutide improved glycemic control (both glycated hemoglobin [HbA1c] and fasting plasma glucose) in pediatric patients with T2D [2]. Based on improvement in glycemic control, liraglutide may help address the unmet need for treatment options in pediatric patients with T2D. A previous pharmacokinetic (PK) analysis of liraglutide comparing data from a pediatric T2D trial to data from two clinical pharmacology adult T2D trials showed that the clinically effective liraglutide dose in adults achieved the same range of exposure in pediatric patients aged 10 to
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