NCT00542009已完成2 期
A 12-Week, Phase 2A, Randomized, Subject And Investigator Blinded, Placebo-Controlled Trial To Evaluate The Safety, Tolerability And Efficacy Of CE-326,597 On Glucose Control And Body Weight In Overweight Adult 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
- 发起方
- Pfizer
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Glucose control
研究概览
简要总结
Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.
排除标准
- •Women of childbearing potential, people with unstable medical conditions, people with gallstones
研究组 & 干预措施
CE-326,597 100 mg QD
Experimental
干预措施: CE-326,597 100 mg QD (Drug)
CE-326,597 50 mg QD
Experimental
干预措施: CE-326,597 50 mg QD (Drug)
CE-326,597 25 mg QD
Experimental
干预措施: CE-326,597 25 mg QD (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CE-326,597 5mg QD
Experimental
干预措施: CE-326,597 5mg QD (Drug)
结局指标
主要结局
Glucose control
时间窗: At Day 84
Body weight
时间窗: At Day 84
次要结局
- Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.(Throughout Study)
- Change in following parameters: Post-prandial and fasting glucose, and insulin(On Day 28)
- Regimen (dose or number) of anti-diabetic agents(At Day 84)
- GlycoMark(On Day 84)
- Waist circumference(On Day 84)
- Proportion of subjects who achieve HbA1C <7% and <6.5%(On Day 84)
- Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.(Throughout Study)
研究者
研究点 (1)
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