NCT00313183已完成2 期
A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SYMLIN in Adolescent Subjects With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
研究概览
简要总结
This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening
- •Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening
- •HbA1c between 6.0% and 10.0%, inclusive, at screening
- •Body weight >=50 kg at screening
排除标准
- •Currently being treated with the following medications: *Any oral antihyperglycemic agent; *Drugs that directly affect gastrointestinal motility
- •Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
- •Has received any investigational drug within 1 month of screening
研究组 & 干预措施
1
Experimental
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
干预措施: pramlintide acetate (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
时间窗: single doses
To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
时间窗: single doses
次要结局
- To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints(single doses)
研究者
研究点 (1)
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