An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 17
- 主要终点
- Incidence of All AEs in Cohort 1 Participants
研究概览
简要总结
VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.
详细描述
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
- 否
入选标准
- •Men and non-pregnant women
- •Diagnosis of T1DM for a minimum of five (5) years
- •Hypoglycemia unawareness or significant glycemic lability
- •Stable diabetic treatment
- •Willingness to use a continuous glucose meter
- •Acceptable candidate for implantation
排除标准
- •History of islet cell, kidney, and/or pancreas transplant.
- •Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
- •Uncontrolled or untreated thyroid disease or adrenal insufficiency
- •Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
- •Non-compliance with current anti-diabetic regimen
- •Detectable stimulated serum C-peptide during screening period assessment.
结局指标
主要结局
Incidence of All AEs in Cohort 1 Participants
时间窗: Enrollment (Visit 3, Day 1) through the Month 4 Visit
Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen.
Change in C-peptide for Cohort 2 Subjects
时间窗: Baseline to Week 26 Visit
Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test.
次要结局
未报告次要终点