NCT00324363已完成3 期
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
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
- 466
- 试验地点
- 1
- 主要终点
- To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.
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.
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 a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
- •HbA1c between 7.1% and 11.0%, inclusive.
- •Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.
排除标准
- •Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
- •Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
- •Have characteristics contraindicating metformin or sulfonylurea use.
- •Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
- •Have used drugs for weight loss within 1 month of screening.
研究组 & 干预措施
Exenatide
Experimental
Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks
干预措施: exenatide (Drug)
Placebo
Placebo Comparator
Placebo in volume equal to exenatide
干预措施: Placebo (Drug)
结局指标
主要结局
To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.
时间窗: 16 weeks
次要结局
- To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements(16 weeks)
研究者
研究点 (1)
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