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

Phase 1

• Conditions: Type 2 Diabetes; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-021057-39-BE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-02
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>;Secondary Objective: • To estimate the pharmacokinetic (PK) parameters of liraglutide in children<br>• To estimate the pharmacodynamic (PD) parameters of liraglutide in children<br><br>;Primary end point(s): Safety and tolerability throughout the trial<br><br>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.