NCT05794581已完成1 期
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
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
- To assess area under the curve (AUC) in glucose metabolism during MMTT
研究概览
简要总结
This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.
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
- •Female or male adults with Type 1 diabetes
- •Ages 18-65 years
- •Type 1 DM for at least 3 years
- •Using an insulin pump or multiple daily injections (MDI) for at least 3 months
- •BMI 25.0 - 35.0
排除标准
- •Significant medical history
- •Uncontrolled diabetes
- •History of surgical treatment for weight loss
- •History of malignancy
研究组 & 干预措施
Victoza
Active Comparator
SC injection of active comparator
干预措施: Victoza (Drug)
CT-868
Experimental
SC injection of CT-868 Intervention
干预措施: CT-868 (Drug)
Placebo
Placebo Comparator
SC injection of placebo matching CT-868 dose
干预措施: Placebo (Drug)
结局指标
主要结局
To assess area under the curve (AUC) in glucose metabolism during MMTT
时间窗: Baseline up to 4 days
次要结局
- Area under the acetaminophen concentration-time (AUC)(0 - 300 minutes)
- To assess changes in continuous glucose monitoring (CGM) measures(Baseline up to 4 days)
研究者
研究点 (1)
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