An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Change in fasting plasma glucose from Visit 1 to each protocol visit
研究概览
简要总结
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has an HbA1c value <=11.0%
- •The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive
排除标准
- •Is currently treated with certain medications, including exogenous insulin
研究组 & 干预措施
Exenatide
Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
干预措施: exenatide (Drug)
结局指标
主要结局
Change in fasting plasma glucose from Visit 1 to each protocol visit
时间窗: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Change in lipids from Visit 1 to each protocol visit
时间窗: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in lipids from Visit 1 to each visit up to open-ended study termination
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
时间窗: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Change in body weight from Visit 1 to each protocol visit
时间窗: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
次要结局
未报告次要终点