NCT00130806终止3 期
A Study to Assess the Efficacy and Tolerability of MK0478 (Muraglitazar, Also, BMS 298585) Coadministered With Insulin in Patients With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 600
- 主要终点
- The difference in daily dose requirements of insulin after 24 weeks
研究概览
简要总结
This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.
详细描述
The duration of treatment is 30 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.)
排除标准
- •People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.
结局指标
主要结局
The difference in daily dose requirements of insulin after 24 weeks
次要结局
- (a) HbA1C; (b) FPG; (c) Percent of patients with HbA1C <7.0%; (d) TG, HDL-C, non-HDL-C and apolipoprotein B; (e) Free Fatty Acids (FFA); (f) the incidence of hypoglycemic events at 24 weeks
研究者
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