Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943501

NN2211-1800

2010-021057-39 (EudraCT Number)

U1111-1111-9256 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 21 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 4 patient groups, including a placebo group

I.a

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

I.b

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

II.a

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

II.b

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo