NCT01066715已完成2 期
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of the Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
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
- 421
- 主要终点
- Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
研究概览
简要总结
The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes.
Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2D (disease duration ≥ 6 months)
- •HbA1c ≥ 6.8% and ≤ 10.0%
- •Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
- •Willingness to maintain stable diet and exercise regime throughout the study
- •Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
排除标准
- •Uncontrolled hypertension
- •History of malignancy within 5 years
- •History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •Advanced stage heart failure (New York Heart Association [NYHA] class 3 or 4)
- •Clinically significant uncontrolled arrhythmias
- •History of tuberculosis
- •Active leg, foot, or decubitus ulcer
- •Any significant inflammatory, rheumatologic, or systemic autoimmune disease
- •History of chronic infections
- •History or any symptoms of a demyelinating disease
- •Major surgery within 3 months
- •Female subjects who are pregnant, planning to become pregnant
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
XOMA 052
Experimental
干预措施: XOMA 052 (Drug)
结局指标
主要结局
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
时间窗: Day 0 pre-dose and Day 182
次要结局
- Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events.(Day 0 through Day 182)
- Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points(Day 0 pre-dose through Day 182)
- Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points(Day 0 pre-dose through Day 182)
- Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points(Day 0 pre-dose through Day 182)
- Serum levels of XOMA 052 (select sites only)(Day 28 pre-dose, Day 168 pre-dose, and Day 182)
研究者
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