NCT01144975已完成2 期
A Randomized Study of the Safety and Biologic Activity 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
- 76
- 主要终点
- 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.
研究概览
简要总结
The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with Type 2 Diabetes Mellitus.
The purpose of this study is to determine whether XOMA 052 improves glycemic control in subjects on Metformin monotherapy whose diabetes is still not adequately controlled.
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 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 measurements >= 7.0% and <= 10.0%
- •On a stable regimen of metformin monotherapy
- •Age >= 18 and <= 75
- •Stable diet and exercise regimen
- •BMI <= 40 kg/m2
排除标准
- •Significant signs and symptoms of uncontrolled hyperglycemia (i.e., polyuria, polydipsia, or polyphagia)
- •Uncontrolled hypertension (systolic > 170 mmHg and/or diastolic > 110 mmHg)
- •Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
- •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)
- •Pulmonary disease requiring medication other than inhaled corticosteroid s
- •History of tuberculosis or positive PPD test.
- •Active leg, foot, or decubitus ulcer
- •Any significant inflammatory, rheumatologic, or systemic autoimmune disease
- •History or any symptoms of a demyelinating disease
- •History of severe non-proliferative or proliferative retinopathy
- •Other protocol-defined inclusion/exclusion criteria may apply
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
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.
时间窗: Day 0 pre-dose through Day 420
次要结局
- Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol.(Day 0 pre-dose through Day 420)
- Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol.(Day 0 pre-dose through Day 420)
- Anti-diabetic activity measured by HbA1c, FPG, OGTT, C-peptide, and insulin collected at time points specified in the protocol.(Day 0 pre-dose through Day 420)
研究者
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