NCT01028963已完成2 期
A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 159
- 主要终点
- Subject incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with Type 2 diabetes mellitus.
详细描述
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with Type 2 diabetes mellitus (T2DM) based on subject incidence of adverse events.
The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes medications.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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
- Triple (Participant, Care Provider, 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
- •Diagnosed type 2 diabetes mellitus
- •Must have a body mass index ≥25 and <45 kg/m2, but if body mass index is ≥25 and <28 kg/m2, then waist circumference must be >94 cm for men and >80 cm for women
- •Must be on a stable dose of metformin for at least 8 weeks prior to randomization
- •Hemoglobin A1c (HbA1c) of 6.5 to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at Screening
排除标准
- •Type 1 diabetes mellitus or history of diabetic ketoacidosis
- •Received insulin treatment within 12 weeks of randomization
- •Received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomization
- •Received sulfonylurea, thiazolidinedione, exenatide, or any other glucose lowering treatment (other than metformin) within 8 weeks of randomization
- •Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral edema, poorly-controlled hypertension (systolic blood pressure >160 or diastolic blood pressure >100), history of unstable angina, myocardial infarction or stroke within 6 months of randomization, or chronic renal failure
- •History or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopenia (WBC count <3.5 x 10(9)/L)
- •History or presence of any form of cancer within the 5 years prior to randomization, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis
- •Fasting serum triglyceride >400 mg/dL
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Active control
Active Comparator
干预措施: pioglitazone (Drug)
Active Study Medication (Group C)
Experimental
CCX140-B
干预措施: CCX140-B (Drug)
Active Study Medication (Group D)
Experimental
CCX140-B
干预措施: CCX140-B (Drug)
结局指标
主要结局
Subject incidence of adverse events
时间窗: 28 days
次要结局
- Effect on fasting plasma glucose concentration(28 days)
研究者
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