NCT04973111已完成1 期
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in insulin secretion rate and ambient glucose levels
研究概览
简要总结
A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1: Obese Otherwise Healthy Males
- •Part 2: Males or Females with T2D
- •Part 1: BMI 30.0-35.0, inclusive
- •Part 2: BMI 27.0-45.0, inclusive
- •18-65 years old, inclusive
- •Stable body weight for 2 months
排除标准
- •Significant medical history
- •Uncontrolled hypertension
- •History of malignancy
研究组 & 干预措施
CT-868
Experimental
SC dose of CT-868 Intervention: Drug: CT-868
干预措施: CT-868 as SC Injection (Drug)
Placebo
Placebo Comparator
SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo
干预措施: Placebo as SC Injection (Drug)
Active Comparator
Active Comparator
SC dose of Active Comparator Intervention: Drug: Active Comparator
干预措施: Active Comparator as SC Injection (Drug)
结局指标
主要结局
Change in insulin secretion rate and ambient glucose levels
时间窗: Baseline up to 4 days
次要结局
- Change in blood glucose levels at each level of glucose infusion(Baseline up to 4 days)
- Change in blood insulin levels at each level of glucose infusion(Baseline up to 4 days)
研究者
研究点 (1)
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