临床试验/NCT00543959

NCT00543959终止2 期

An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Merck Sharp & Dohme LLC0 个研究点目标入组 346 人开始时间: 2006年6月最近更新: 2015年6月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Merck Sharp & Dohme LLC
入组人数: 346
主要终点: Body fluid gain from baseline after 12 weeks

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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Unknown

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