Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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)