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Trial · Interventional

CompletedPhase 1Registry data

Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

NCTNCT00943501 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1800Other idU1111-1111-9256Other id2010-021057-39
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
21 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
4 countries

United States, Belgium, Slovenia, United Kingdom

Start
Nov 2009
Primary completion
Sept 2011
Completion
Sept 2011
First posted
22 Jul 2009 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 1

    Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

    NCT00943501

    Nov 2009 to Sept 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • liraglutideDrug
  • placeboDrug
  • liraglutideDrug
  • placeboDrug

Arms4

  • Experimental

    I.a

  • Placebo comparator

    I.b

  • Experimental

    II.a

  • Placebo comparator

    II.b

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number and type of adverse events

    Time frame · up to 8 weeks

Secondary outcomes(2)

  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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

3 results

Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis.

Petri et al. 2015Clinical pharmacokineticscited by 26

PMID 25603819PMC4449373DOI 10.1007/s40262-014-0229-zPUB-25603819

Free to read · publisher termsCC BY-NC3 results
Read at sourceSee results (3)

Indexing hint: Randomized controlled trial · 2014

9 results

Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

Klein et al. 2014Diabetes technology & therapeuticscited by 84

PMID 25036533PMC4183917DOI 10.1089/dia.2013.0366PUB-25036533

Rights unknown9 results
Source linkSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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