Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT00943501

Run by

Novo Nordisk A/S

People needed

21

Starts

2009-11-01

Expected to finish

2011-09-01

Last updated by the study team

2017-01-26

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• Novo Nordisk Investigational Site — Cypress, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Louisville, Kentucky, United States
• Novo Nordisk Investigational Site — Kansas City, Missouri, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Cleveland, Ohio, United States
• Novo Nordisk Investigational Site — Toledo, Ohio, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Memphis, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Brussels, Belgium
• Novo Nordisk Investigational Site — Ljubljana, Slovenia
• Novo Nordisk Investigational Site — Birmingham, United Kingdom
• Novo Nordisk Investigational Site — Manchester, United Kingdom
• Novo Nordisk Investigational Site — Nottingham, United Kingdom
• Novo Nordisk Investigational Site — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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