NCT00481117已完成1 期
Safety, Tolerability, PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 12
- 主要终点
- Safety labs, ECGs, vital signs, adverse events.
研究概览
简要总结
This study intends to evaluate how safe and well tolerated the LY2405319 compound is when given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes.
详细描述
Subjects in Part 1 will be randomized to receive LY2405319 or placebo over 7 days in one of 4 dose level groups, in ascending order: 1 mg, 3 mg, 10 mg, or 20 mg.
Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days, and will receive the dose level determined to be the most well tolerated in Part 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women without child bearing capability
- •Ages 35 to 70 years
- •Type 2 diabetic subjects, diagnosed for at least 3 months
- •Average body weight (relative to height)
- •Willing to be available for the duration of the study
排除标准
- •Significant medical illnesses (except Type 2 diabetes)
- •Abnormal 12-lead electrocardiogram (ECG )
- •Current or previous use of insulin for greater than 7 days for control of diabetes
- •Regular use of drugs of abuse
- •Excessive alcohol use
结局指标
主要结局
Safety labs, ECGs, vital signs, adverse events.
时间窗: End of dosing period
次要结局
- Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples)(End of dosing period)
研究者
研究点 (12)
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