NCT00690638已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus
Phenomix0 个研究点目标入组 480 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 主要终点
- To demonstrate changes in HbA1c
研究概览
简要总结
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
- •BMI 25 to 48 kg/m2, inclusive
- •HbA1c 7.0% - 10.0%, inclusive
- •Age 18 to 75 years, inclusive
排除标准
- •Currently on 3 or more oral antidiabetic drugs or insulin.
- •Type 1 diabetes mellitus
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Experimental
PHX1149T 200 mg
干预措施: PHX1149T (Drug)
3
Experimental
PHX1149T 400 mg
干预措施: PHX1149T (Drug)
结局指标
主要结局
To demonstrate changes in HbA1c
时间窗: Day 28 to Day 196
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
PPAR - Combination With MetforminDiabetes MellitusNCT00162240Bristol-Myers Squibb534
已完成
3 期
PPAR-COMBO With SulfonylureaMetabolics Diabetes NosNCT00162175Bristol-Myers Squibb534
已完成
3 期
Efficacy and Safety of Odevixibat in Patients With Alagille SyndromeAlagille SyndromeNCT04674761Albireo52
进行中（未招募）
3 期
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's SyndromeSjogren SyndromeNCT05349214Novartis Pharmaceuticals506
终止
3 期
Instillation of Gemcitabine in Patients With Superficial Bladder CancerBladder NeoplasmsNCT00191477Eli Lilly and Company355