EUCTR2010-021057-39-BE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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)
- •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
排除标准
- •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
研究者
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