Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

Liraglutide: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Pediatric (10-17 Years Old) With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).

Inclusion Criteria:

• BMI greater than 85th percentile for age and gender
• Currently being treated with diet and exercise or metformin alone
• HbA1c (glycosylated haemoglobin) between 6.5 and 11.0%

Exclusion Criteria:

• Any clinically significant disease other than type 2 diabetes, as judged by the trial physician
• Previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)