NCT00473525已完成2 期
A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin
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
- Pfizer
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- HbA1C levels (%)
研究概览
简要总结
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes
- •Hb1AC >7%-11% inclusive
- •Male and females 18-70; females must be post-menopausal
- •On a stable dose of metformin hydrochloride
排除标准
- •Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
- •Women of childbearing potential, pregnant or nursing
- •Evidence of diabetic complications with significant end-organ damage
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PF-00734200 10 mg QD
Experimental
干预措施: PF-00734200 10 mg QD (Drug)
PF-00734200 20 mg QD
Experimental
干预措施: PF-00734200 20 mg QD (Drug)
PF-00734200 5 mg QD
Experimental
干预措施: PF-00734200 5 mg QD (Drug)
PF-00734200 2 mg QD
Experimental
干预措施: PF-00734200 2 mg QD (Drug)
结局指标
主要结局
HbA1C levels (%)
时间窗: 12 weeks
Evaluation of Dose Response in HbA1c (%)
时间窗: 12 weeks
次要结局
- Insulin and Glucose AUC following a mixed meal tolerance test(12 weeks)
- Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%(12 weeks)
- Incidence of Adverse Events(12 weeks)
研究者
研究点 (1)
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