Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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
Verified date | January 2017 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 21 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Novo Nordisk Investigational Site | Brussels | |
Slovenia | Novo Nordisk Investigational Site | Ljubljana | |
United Kingdom | 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 States | Novo Nordisk Investigational Site | Aurora | Colorado |
United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
United States | Novo Nordisk Investigational Site | Cypress | California |
United States | Novo Nordisk Investigational Site | Dallas | Texas |
United States | Novo Nordisk Investigational Site | Iowa City | Iowa |
United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
United States | Novo Nordisk Investigational Site | Los Angeles | California |
United States | Novo Nordisk Investigational Site | Los Angeles | California |
United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
United States | Novo Nordisk Investigational Site | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Belgium, Slovenia, United Kingdom,
Klein DJ, Battelino T, Chatterjee DJ, Jacobsen LV, Hale PM, Arslanian S; NN2211-1800 Study Group.. Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled tria — View Citation
Petri KC, Jacobsen LV, Klein DJ. Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis. Clin Pharmacokinet. 2015 Jun;54(6):663-70. doi: 10.1007/s40262-014-0229-z. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and type of adverse events | up to 8 weeks | ||
Secondary | Pharmacokinetics: Area under the plasma concentration vs. time curve | within dosing interval | ||
Secondary | Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin | throughout study duration (pre-, during and post-treatment) |
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