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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 September 2012 |
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Main ID: |
EUCTR2010-021057-39-SI |
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Date of registration:
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08/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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) and Adult Subjects with Type 2 Diabetes -
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Date of first enrolment:
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09/12/2010 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021057-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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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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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); adults 18 - 45 years (both inclusive, at screening)
• BMI: > 85th percentile for age and gender (pediatric) or = 25 kg/m^2 (adults)
• 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) yes
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
• Use of any anti-diabetic treatment other than metformin
• 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: 14.0
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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Main Objective: Part I: 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).
Part II: To assess the safety and tolerability of liraglutide regimen starting with the 0.6 mg daily dose for one week followed by 1.2 mg daily the next week and ending with1.8 mg daily (the 3rd week) in the pediatric population (10 – 17 years of age).
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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: Parts I and II
• to estimate the pharmacokinetic (PK) parameters of liraglutide in children
• to estimate the pharmacodynamic (PD) parameters of liraglutide in children
Part II
• to compare the PK and PD parameters of liraglutide between adults and children
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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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Date Posted:
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Date Completed:
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URL:
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