NCT00943501已完成1 期
Liraglutide: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Pediatric (10-17 Years Old) With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number and type of adverse events
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI greater than 85th percentile for age and gender
- •Currently being treated with diet and exercise or metformin alone
- •HbA1c (glycosylated haemoglobin) between 6.5 and 11.0%
排除标准
- •Any clinically significant disease other than type 2 diabetes, as judged by the trial physician
- •Previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)
研究组 & 干预措施
I.a
Experimental
干预措施: liraglutide (Drug)
I.b
Placebo Comparator
干预措施: placebo (Drug)
II.a
Experimental
干预措施: liraglutide (Drug)
II.b
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number and type of adverse events
时间窗: up to 8 weeks
次要结局
- Pharmacokinetics: Area under the plasma concentration vs. time curve(within dosing interval)
- Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin(throughout study duration (pre-, during and post-treatment))
研究者
研究点 (1)
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