NCT00425919终止2 期
A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes
Wyeth is now a wholly owned subsidiary of Pfizer68 个研究点 分布在 14 个国家目标入组 500 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 500
- 试验地点
- 68
- 主要终点
- Fasting Plasma Glucose
研究概览
简要总结
The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.
详细描述
The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).
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
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
- •Men and women of non-childbearing potential, 18 to 70 years old
- •Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication
- •BMI > 23 and < 43
- •For subjects currently treated with 1 antidiabetic medication: HbA1c is greater than or equal to 6.8% and less than or equal to 8.5%.
- •For subjects not currently treated with antidiabetic medications: HbA1c is greater than or equal to 7.2% and less than or equal to 9.0%
排除标准
- •Subjects requiring insulin therapy
- •Subjects currently receiving 2 or more oral antidiabetic medications
- •Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit
- •Subjects receiving warfarin
- •Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit
- •Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)
结局指标
主要结局
Fasting Plasma Glucose
次要结局
- Mean changes of HbA1c, Fasting Insulin, HOMA-IR and QUICKI indices, Body weight, waist measurements, total cholesterol, LDL-C, HDL-C, total/HDL, apolipoprotein A-1 & B, triglycerides, free fatty acids, hs C-reactive protein, adiponectin, edema.
研究者
研究点 (68)
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