Safety of Liraglutide in Pediatric Patients 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). The trial consists of two parts: I and II.
Part I, involving children with type 2 diabetes, will investigate the safety and tolerability of liraglutide in children receiving an escalating weekly dose over 5 weeks compared with placebo. Part II involves a reference group of children and adults with type 2 diabetes who will also receive an escalating weekly dose of liraglutide over 3 or 4 weeks, each reference group being compared with placebo.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Diabetes Mellitus, Type 2
liraglutide, placebo, liraglutide, placebo, liraglutide, placebo
Novo Nordisk Clinical Trial Call Center
Active, not recruiting
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00943501
- Information obtained from ClinicalTrials.gov on October 02, 2011
Medical and Biotech [MESH] Definitions
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
Diabetes Mellitus, Experimental
Diabetes mellitus induced experimentally by administration of various diabetogenic agents or by PANCREATECTOMY.
Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).
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