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Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943501
First Posted: July 22, 2009
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
July 21, 2009
July 22, 2009
January 26, 2017
November 2009
September 2011   (Final data collection date for primary outcome measure)
Number and type of adverse events [ Time Frame: up to 8 weeks ]
Number and type of adverse events [ Time Frame: up to 8 weeks for Part I and up to 6 weeks for Part II ]
Complete list of historical versions of study NCT00943501 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area under the plasma concentration vs. time curve [ Time Frame: within dosing interval ]
  • Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin [ Time Frame: throughout study duration (pre-, during and post-treatment) ]
Same as current
Not Provided
Not Provided
 
Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
  • Drug: placebo
    Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
  • Drug: liraglutide
    Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
  • Drug: placebo
    Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
  • Experimental: I.a
    Intervention: Drug: liraglutide
  • Placebo Comparator: I.b
    Intervention: Drug: placebo
  • Experimental: II.a
    Intervention: Drug: liraglutide
  • Placebo Comparator: II.b
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2011
September 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Slovenia,   United Kingdom,   United States
 
 
NCT00943501
NN2211-1800
U1111-1111-9256 ( Other Identifier: WHO )
2010-021057-39 ( EudraCT Number )
Yes
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP