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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 August 2017 |
Main ID: |
EUCTR2010-021057-39-BE |
Date of registration:
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02/03/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Paediatric (10 – 17 years old) Subjects with Type 2 Diabetes
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Scientific title:
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A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Paediatric (10 – 17 years old) Subjects with Type 2 Diabetes |
Date of first enrolment:
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17/03/2011 |
Target sample size:
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21 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021057-39 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Slovenia
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: • Signed informed consent
• Male and female subjects with type 2 diabetes
• Age – pediatric: 10-17 years (both inclusive)
• BMI: > 85th percentile for age and gender (pediatric)
• Drug-naïve (diet/exercise) or treated with metformin, stable dose and dosing frequency for at least 4 weeks prior to screening with HbA1c = 6.5% and = 11.0%
• Good general health based on medical history and physical examination including ECG and routine laboratory analysis
• At randomization: FPG =110 – = 240 mg/dL (= 6.1 mmol/L and = 13.3mmol/L) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: • Presence of any clinically significant disease or medical history (other than type 2 diabetes)
• Type 1 diabetes
• Previous treatment within last three months with any antidiabetic agent other than metformin (except for prior short term treatment with insulin, at the discretion of the investigator and if given more than 1 month before the first dose)
• Female of childbearing potential/breast feeding, pregnant, intent to become pregnant or not using adequate contraception
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes MedDRA version: 14.1
Level: PT
Classification code 10067585
Term: Type 2 diabetes mellitus
System Organ Class: 10027433 - Metabolism and nutrition disorders
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Intervention(s)
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Trade Name: Victoza(R) Product Name: Victoza(R) Pharmaceutical Form: Solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Other descriptive name: NNC90-1170 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): Safety and tolerability throughout the trial
Laboratory safety (including plasma glucose, haematology, clinical chemistry and urinalysis), physical examination, vital signs, electrocardiogram (ECG), funduscopy, liraglutide antibodies, hypoglycaemic events and adverse events will be reported.
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Secondary Objective: • To estimate the pharmacokinetic (PK) parameters of liraglutide in children • To estimate the pharmacodynamic (PD) parameters of liraglutide in children
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Main Objective: To assess the safety and tolerability of 0.3, 0.6, 0.9, 1.2 and 1.8 mg doses of liraglutide in the paediatric population (10 – 17 years of age).
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Secondary ID(s)
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2010-021057-39-GB
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NN2211-1800
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Source(s) of Monetary Support
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Results
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Results available:
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