PER-087-10已完成未知
A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2DM) AND INADEQUATE GLYCEMIC CONTRO
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 22 人开始时间: 2011年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 22
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
- 年龄范围
- 18 至 70(—)
入选标准
- •Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
- •Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
- •Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
- •Is a male, or a female who is highly unlikely to conceive.
排除标准
- •Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
- •Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
- •Has required insulin therapy within 14 weeks prior to signing informed consent;
- •Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
- •Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
- •Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
- •Has a history of malignancy or clinically important hematological disorder
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