NCT00241423已完成2 期
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time-averaged serum glucose during a 24-hour period
研究概览
简要总结
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has an HbA1c between 7.0% and 10.0%, inclusive.
- •Subject has a body mass index (BMI) >25 kg/m^2 and <50 kg/m^
- •Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.
排除标准
- •Subject has been treated with any of the following medications: *exogenous insulin for more than 1 week within 3 months of screening, *sulfonylureas or meglitinides within 2 months of screening, *alpha-glucosidase inhibitors within 2 months of screening, *pramlintide acetate injection within 2 months of screening.
- •Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.
研究组 & 干预措施
Exenatide
Experimental
Exenatide and the subject's current oral antidiabetic agent regimen
干预措施: exenatide (Drug)
Placebo
Placebo Comparator
Placebo and the subject's current oral antidiabetic agent regimen
干预措施: Placebo (Drug)
结局指标
主要结局
Time-averaged serum glucose during a 24-hour period
时间窗: Every half-hour to hour for 24 hours
Time-averaged serum glucose during a 24-hour period
次要结局
- To compare the effects of exenatide and placebo on serum glucose(Each half-hour to 2 hours for 24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
4 期
The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young AdultsImpaired Glucose ToleranceObesityCardiovascular DiseaseInsulin ResistanceNCT00845559Yale University
已完成
2 期
Exeantide in Type 2 Diabetes on InsulinType 2 DiabetesNCT01154933University at Buffalo24
Unknown
2 期
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 DiabetesType 2 DiabetesNCT01140893University Hospital, Caen110
已完成
4 期
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and PrediabetesType 2 Diabetes MellitusNCT01181986Carl T. Hayden VA Medical Center76
已完成
4 期
Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 DiabetesType 2 Diabetes MellitusNCT00948168Cliniques universitaires Saint-Luc- Université Catholique de Louvain34