NCT00699790已完成2 期
A 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients
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
- •Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%
- •Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL
- •BMI ≤ 40 kg/m2
排除标准
- •Active tuberculosis
- •Symptoms of poorly controlled diabetes
- •History of diabetic ketoacidosis
- •Significant cardiovascular history or gastrointestinal disorders
- •History of unstable or rapidly progressing renal disease
- •Active liver disease and/or significant abnormal liver function
- •Abnormal chest x-ray at screening indicative of tuberculosis or other infection
研究组 & 干预措施
A1
Experimental
干预措施: CCR2 Antagonist (Drug)
A2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: after 12 weeks of treatment
次要结局
- Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured(throughout the 12 weeks of treatment)
研究者
研究点 (1)
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