NCT00543959终止2 期
An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 346
- 主要终点
- Body fluid gain from baseline after 12 weeks
研究概览
简要总结
A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
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
- •Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
- •Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened
排除标准
- •Patients taking any medicines that affect body fluid level such as a diuretic or water pill
- •Patients taking niacin or other certain medications
- •Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
- •Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
研究组 & 干预措施
Part1 - Arm 1
Experimental
Part1: Arm 1: drug
干预措施: MK0533 (Drug)
Part 2 - Arm 2
Experimental
Part 2- Arm 2: drug 5mg
干预措施: MK0533 (Drug)
Part 2 - Arm 3
Experimental
Part 2 - Arm 3: drug 15mg
干预措施: MK0533 (Drug)
Part 2 - Arm 4
Experimental
Part 2 - Arm 4: drug 30mg
干预措施: MK0533 (Drug)
结局指标
主要结局
Body fluid gain from baseline after 12 weeks
时间窗: 12 weeks
次要结局
- Fasting plasma glucose after 12 weeks(12 weeks)
研究者
相似试验
Unknown
2 期
A Study of the Efficacy of MK-0683 in Patients With Polycythaemia Vera and Essential ThrombocythaemiaPolycythemia VeraEssential ThrombocythemiaNCT00866762Copenhagen University Hospital at Herlev60
进行中（未招募）
不适用
An Efficacy and Tolerability Study of MK-0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - NDEUCTR2006-002090-47-ITMERCK SHARP DOHME100
进行中（未招募）
不适用
An Efficacy and Tolerability Study of MK-0533 in Patients with Type II Diabetes Mellitus Who Have Inadequate Glycemic Control.Type II DiabetesMedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2006-002090-47-HUMerck & Co., Inc.600
进行中（未招募）
不适用
An Efficacy and Tolerability Study of MK-0533 in Patients with Type II Diabetes Mellitus Who Have Inadequate Glycemic Control.Type II DiabetesMedDRA version: 7.1Level: LLTClassification code 10012613EUCTR2006-002090-47-DEMerck & Co. Inc.600
进行中（未招募）
不适用
An Efficacy and Tolerability Study of MK-0533 in Patients with Type II Diabetes Mellitus Who Have Inadequate Glycemic Control. - 12 week study of MK - 0533 in patients with T2DMType II DiabetesMedDRA version: 7.1Level: LLTClassification code 10012613EUCTR2006-002090-47-CZMerck & Co., Inc.600