NCT00454233已完成2 期
A Randomized, Double Blind, Placebo and Active Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Potential Efficacy of a 12-Week Treatment With YM543 in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)
研究概览
简要总结
The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive subjects diagnosed with T2DM
- •Stable diet and exercise program for at least 6 weeks
- •Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1
排除标准
- •Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders
- •Use of insulin or oral blood glucose lowering drugs in the last 3 months
研究组 & 干预措施
1
Experimental
Dose 1
干预措施: YM543 (Drug)
2
Experimental
Dose 2
干预措施: YM543 (Drug)
3
Experimental
Dose 3
干预措施: YM543 (Drug)
4
Experimental
Dose 4
干预措施: YM543 (Drug)
5
Active Comparator
干预措施: Metformin (Drug)
6
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)
时间窗: 3 Months
次要结局
- Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel)(3 Months)
研究者
研究点 (2)
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