NCT01607294已完成2 期
A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
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
- 60
- 主要终点
- assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes
研究概览
简要总结
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 meeting all of the following:
- •Minimum 6 month history of diabetes prior to screening visit;
- •Fasting C-peptide ≥ 0.8 ng/mL at screening visit;
- •HbA1C at screening visit 7-10%;
- •Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements.
- •BMI at screening visit from 25-35 kg/m2;
- •LDL-C at screening ≥ 100 mg/dL
排除标准
- 未提供
研究组 & 干预措施
ETC-1002
Experimental
ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
干预措施: ETC-1002 (Drug)
Placebo
Placebo Comparator
Placebo daily 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes
时间窗: 4 weeks
evaluate the change in LDL-C from baseline to various time points
次要结局
- assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin(4 weeks)
- assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes(4 weeks)
- assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters(4 weeks)
研究者
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