NCT00259896已完成1 期
A Randomized, Open-label, Placebo-controlled, Repeat-dose Study to Assess the Pharmacokinetics and Pharmacodynamics of 5 Micrograms Exenatide Administered Subcutaneously Twice Daily for 7 Days in Healthy Normal Volunteers and in Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pharmacodynamic measurements during 7 days of dosing.
研究概览
简要总结
This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have type 2 diabetes mellitus that has been diagnosed for at least three months
- •must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea
- •must be willing to wash-out of these medications for 14 days prior to the start of the study
- •must have bloodwork that meets certain criteria (for example, total cholesterol < 240 mg/dL)
排除标准
- •must not have any other major illness other than diabetes
结局指标
主要结局
Pharmacodynamic measurements during 7 days of dosing.
次要结局
- Pharmacokinetic measurements during 7 days of dosing.
研究者
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