Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 1/27/2017 |
| Start Date: | November 2009 |
| End Date: | September 2011 |
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
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).
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).
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)
We found this trial at
14
sites
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