Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
研究概览
简要总结
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
- •HbA1c between 7.1% and 10.0%, inclusive.
- •Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.
排除标准
- •Patient previously in a study using exenatide or GLP-1 analogs.
- •Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
- •Treated with oral insulin within 3 months of screening.
研究组 & 干预措施
Exenatide
After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
干预措施: exenatide (Drug)
Placebo
After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16
Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
时间窗: Baseline, Week 16
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
次要结局
- Change in body weight from Baseline to Week 16(Baseline, Week 16)
- Changes in beta cell function and insulin sensitivity between Baseline and Week 16(Baseline, Week 16)
- Changes in lipids between Baseline and Week 16(Baseline, Week 16)
- Percentage of subjects reaching the target HbA1c (<7%)(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16)
- Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose(Baseline, Week 16)