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OpenTrials
Completed

NCT Number: NCT00943501

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

liraglutide

Drug

Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)

Placebo

Drug

Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)

Primary outcomes

  1. Number and type of adverse events

    Time frame: up to 8 weeks

Secondary outcomes

  1. Pharmacokinetics: Area under the plasma concentration vs. time curve

    Time frame: within dosing interval

  2. Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin

    Time frame: throughout study duration (pre-, during and post-treatment)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2009
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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