Clinical trial NCT00943501: Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 21
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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)

Primary outcomes:
measure: Number and type of adverse events
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Pharmacokinetics: Area under the plasma concentration vs. time curve
timeFrame: within dosing interval
measure: Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin
timeFrame: throughout study duration (pre-, during and post-treatment)
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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 trial. Diabetes Technol Ther. 2014 Oct;16(10):679-87. doi: 10.1089/dia.2013.0366. Epub 2014 Jul 18.
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.