NCT01665352已完成2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on 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
- 入组人数
- 186
- 试验地点
- 19
- 主要终点
- Change from baseline in HbA1c (%) as compared to placebo
研究概览
简要总结
The purpose of this study is to compare the safety and effect of TTP054 versus placebo on glucose control 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 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 mellitus
- •On a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (OAD) agent
- •HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5%
排除标准
- •History or evidence of significant diabetic complications
- •History of heart attack, stroke or congestive heart failure
- •Severe, uncontrolled hypertension
- •Frequent hypoglycemia
- •Women of child-bearing potential
研究组 & 干预措施
TTP054 400 mg
Experimental
干预措施: TTP054 (Drug)
TTP054 200 mg
Experimental
干预措施: TTP054 (Drug)
TTP054 800 mg
Experimental
干预措施: TTP054 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c (%) as compared to placebo
时间窗: Day 1 to Day 84
次要结局
- Subject achievement of body weight loss ≥ 2%(Day 1 and Day 84)
- Change from baseline in fasting plasma glucose (mg/dL)(Day 1, Day 14, Day 28, Day 56 and Day 84)
- Subject achievement of HbA1c <7%(Day 84)
- Change from baseline in body weight(Day 1, Day 14, Day 28, Day 56 and Day 84)
研究者
研究点 (19)
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