Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
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). 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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Diabetes Mellitus, Type 2
Intervention
liraglutide, placebo, liraglutide, placebo, liraglutide, placebo
Location
Novo Nordisk Clinical Trial Call Center
Los Angeles
California
United States
90036
Status
Active, not recruiting
Source
Novo Nordisk
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00943501
- Information obtained from ClinicalTrials.gov on October 02, 2011
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
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.
Polyuria
Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).
Clinical Trials
A Trial in Type 2 Diabetes Comparing NN9535 to Placebo and Liraglutide
This trial is conducted in Africa, Asia and Europe. Subjects participating in this trial will be randomised to treatment with NN9535, placebo or liraglutide. Key efficacy parameter is HbA1...
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (p...
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therap...
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, a...
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
PubMed Articles
Liraglutide: a review of its use in the management of type 2 diabetes mellitus.
Liraglutide (Victoza®) is a subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and used as an adjunct to diet and exercise in the trea...
Liraglutide is a novel once-daily human glucagon-like peptide (GLP)-1 analog in clinical use for the treatment of type 2 diabetes. To study metabolism and excretion of [(3)H]-liraglutide, a single sub...
The efficacy and safety of liraglutide.
Aim of the review To systematically analyze the efficacy and safety of liraglutide for the treatment of diabetes mellitus in comparison to other mono- and combination therapies. Method PubMed (any dat...
A 59-year old man with moderate and stable psoriasis through 15 years was admitted to our Department with inadequately controlled type 2 diabetes. Treatment was initiated with the glucagon-like pepti...
Liraglutide, an analog of glucagon-like peptide-1 (GLP-1), is an effective anti-diabetic agent with few side effects. Since native GLP-1 exerts vascular effects, we investigated changes in pancreatic...
