Diabetes, Diabetes Mellitus, Type 2
Conditions
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).
Interventions
DRUGliraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
DRUGplacebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and type of adverse events | up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Area under the plasma concentration vs. time curve | within dosing interval |
| Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin | throughout study duration (pre-, during and post-treatment) |
Countries
Belgium, Slovenia, United Kingdom, United States
Outcome results
None listed