CTRI/2009/091/000614Other2 期
A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- Merck Co Inc
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patient has type 2 diabetes
- •Patient is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a PPARg agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose
- •Female patient is unable to have children
排除标准
- •Patient has a history of type 1 diabetes or ketoacidosis
- •Patient has been treated with a PPARg agonist in the last 12 weeks
- •Patient has been treated with insulin in the last 12 weeks
- •Patient has had statin therapy in the last 12 weeks
- •Patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks
- •Patient has a history of coronary artery disease
- •Patient has had a stroke or transient ischemic attack
- •Patient has congestive heart failure
- •Patient is HIV positive
- •Patient has a history of cancer except certain skin or cervical cancers
- •Patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit
- •Patient is breast-feeding
- •Patient will donate eggs during the study
研究者
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