NCT00543361终止3 期
A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 382
- 主要终点
- This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
研究概览
简要总结
The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are men and non-pregnant women ages 21 to 78 years
- •Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study
排除标准
- •Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
- •Patients undergoing surgery within 30 days of Visit 1
- •Patients taking Warfin or Warfin-like anticoagulants
- •Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
结局指标
主要结局
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
时间窗: over the course of 52 weeks
次要结局
- MK0767 will be safe and well tolerated.(over the course of 52 weeks)
研究者
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