A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To assess the pharmacodynamics of exenatide
研究概览
简要总结
This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide 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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
- •Has HbA1c 6.0% to 11.0%, inclusive, at screening.
- •Has a body weight of >= 50 kg at screening.
排除标准
- •Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
- •Currently participates in any other interventional study.
- •Is currently treated with any of the following excluded medications:
- •Sulfonylurea chlorpropamide
- •Thiazolidinedione within 3 months of screening.
- •Αlpha glucosidase inhibitor within 3 months of screening.
- •Meglitinide within 3 months of screening.
- •Insulin within 3 months of screening.
- •Pramlintide within 3 months of screening.
研究组 & 干预措施
Sequence 1
Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
干预措施: Exenatide - Exenatide - Placebo (Drug)
Sequence 2
Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
干预措施: Exenatide - Placebo - Exenatide (Drug)
Sequence 3
Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg
干预措施: Placebo - Exenatide - Exenatide (Drug)
结局指标
主要结局
To assess the pharmacodynamics of exenatide
时间窗: Three day-long (8 hour) assessments over a 5-week period
To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration.
Number of adverse events
时间窗: Visit 2 through Visit 4
Adverse events will be assessed at all visits after the Screening Visit \[Visit 2 (first time subject is dosed) through Visit 4 (study termination)\]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values
To assess the pharmacokinetics of exenatide
时间窗: Three day-long (8 hour) assessments over a 5-week period
To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve.
次要结局
未报告次要终点