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Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00943501
First received: July 21, 2009
Last updated: April 24, 2014
Last verified: April 2014

July 21, 2009
April 24, 2014
November 2009
September 2011   (final data collection date for primary outcome measure)
Number and type of adverse events [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
Number and type of adverse events [ Time Frame: up to 8 weeks for Part I and up to 6 weeks for Part II ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin [ Time Frame: throughout study duration (pre-, during and post-treatment) ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Klein DJ, Battelino T, Chatterjee DJ, Jacobsen LV, Hale PM, Arslanian S; NN2211-1800 Study Group. Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Diabetes Technol Ther. 2014 Oct;16(10):679-87. doi: 10.1089/dia.2013.0366. Epub 2014 Jul 18.

*   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)
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Slovenia,   United Kingdom
 
NCT00943501
NN2211-1800, U1111-1111-9256, 2010-021057-39
Yes
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: D J Chatterjee, Ph.D. Novo Nordisk A/S
Novo Nordisk A/S
April 2014

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