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NCT00943501 Clinical Trial

Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00943501
Other study ID # NN2211-1800
Secondary ID U1111-1111-92562
Status Completed
Phase Phase 1
First received July 21, 2009
Last updated January 25, 2017
Start date November 2009
Est. completion date September 2011

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• liraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
• placebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
• liraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
• placebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Belgium,  Slovenia,  United Kingdom, 

References & Publications (2)

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

Outcome
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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