NCT00998699已完成2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well-controlled Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)
研究概览
简要总结
The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration.
The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
XOMA 052
Active Comparator
干预措施: Xoma 052 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)
时间窗: Day 0 pre-dose and Day 112
次要结局
- Change in HbA1c levels(Day 0 pre-dose and Day 112)
- Change in systemic inflammation markers(Day 0 pre-dose and Day 112)
- Change in meal-stimulated GLP-1 and GIP(Day 0 pre-dose and Day 112)
- Change in lipids profile(Day 0 pre-dose and Day 112)
- Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.(Day 0 (baseline) through Day 364)
- Change in insulin requirements(Day -3 through Day 0 pre-dose and Day 109 through Day 112))
- Change in fasting glucose(Day 0 pre-dose and Day 112)
- Change in fasting glucagon and cortisol(Day 0 pre-dose and Day 112)
- Measurement of serum concentrations of XOMA 052(Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364)
研究者
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