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

• Conditions: Type 2 Diabetes; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-08
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

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