NCT00162305已完成2 期
A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects
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
- AstraZeneca
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects
研究概览
简要总结
The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects
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
- •Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive).
- •Fasting glucose (FG) < - 240 mg/dL, while on metformin or antidiabetic diet alone.
- •HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%
排除标准
- •Women of childbearing potential
研究组 & 干预措施
4
Placebo Comparator
干预措施: Placebo (Drug)
1
Active Comparator
干预措施: BMS-512148 (Drug)
2
Active Comparator
干预措施: BMS-512148 (Drug)
3
Active Comparator
干预措施: BMS-512148 (Drug)
结局指标
主要结局
To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects
时间窗: 14 days
Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
次要结局
- To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin(14 days)
- To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis(14 days)
- To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine(14 days)
- To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum(14 days)
- To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption(14 days)
- To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects.(14 days)
- To identify potential biomarkers in both urine and blood(14 days)
研究者
研究点 (1)
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