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Clinical Trials/NCT00943501
NCT00943501
Completed
Phase 1

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

Novo Nordisk A/S1 site in 1 country21 target enrollmentStarted: November 2009Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 2
Interventionsliraglutideplacebo
Drugsliraglutideplacebo

Overview

Phase
Phase 1
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Number and type of adverse events
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
10 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

I.a

Experimental

Intervention: liraglutide (Drug)

I.b

Placebo Comparator

Intervention: placebo (Drug)

II.a

Experimental

Intervention: liraglutide (Drug)

II.b

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Number and type of adverse events

Time Frame: up to 8 weeks

Secondary Outcomes

  • Pharmacokinetics: Area under the plasma concentration vs. time curve(within dosing interval)
  • Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin(throughout study duration (pre-, during and post-treatment))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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