Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Drug: placebo
- Registration Number
- NCT00943501
- Lead Sponsor
- Novo Nordisk A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description II.a liraglutide - II.b placebo - I.b placebo - I.a liraglutide -
- Primary Outcome Measures
Name Time Method Number and type of adverse events up to 8 weeks
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Sheffield, United Kingdom