NCT00381342已完成3 期
Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
研究概览
简要总结
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes
- •Treating diabetes with diet and exercise
- •HbA1c between 6.5% and 10.0%, inclusive
- •Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive
排除标准
- •Have previously completed or withdrawn from this study
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •Have been treated with any antidiabetic agent
- •Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
- •Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
研究组 & 干预措施
Exenatide 5 mcg/exenatide 5 mcg
Experimental
Exenatide 5 mcg; then exenatide 5 mcg
干预措施: exenatide (Drug)
Exenatide 5 mcg/exenatide 10 mcg
Experimental
Exenatide 5 mcg, then exenatide 10 mcg
干预措施: exenatide (Drug)
Placebo
Placebo Comparator
Placebo in volumes equivalent to exenatide
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
时间窗: Baseline, Week 24
Change in HbA1c from Baseline to Week 24
次要结局
- Change in body weight from Baseline to Week 24(Baseline, Weeks 4, 8, 12, 16, and 24)
- Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less(Baseline, Weeks 4, 8, 12, 16, 24)
- Change in glucose measurements from Baseline to Week 24(Baseline, Weeks 4, 8, 12, 16, 24)
- Change in fasting serum glucose (FSG) from Baseline to Week 24(Baseline, Weeks 4, 8, 12, 16, and 24)
- Changes in beta-cell function and insulin sensitivity from Baseline to Week 24(Baseline, Weeks 4, 8, 12, 16, and 24)
- Changes in fasting and 30, 60, 120 and 180-minute glucose measurements(Immediately before glucose load, then 30, 60, 120, and 180 minutes post)
研究者
研究点 (1)
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