EUCTR2010-021057-39-SI进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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