A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 34
- 主要终点
- Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
研究概览
简要总结
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of type 1 diabetes for up to 3 months at screening
- •Insulin dependency
- •Fasting C-peptide levels >= 0.22 nmol/L
- •Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)
排除标准
- •Pregnancy or intent to conceive in the next 2 years
- •Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
- •Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
研究组 & 干预措施
DiaPep277
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
干预措施: DiaPep277 (Drug)
Placebo
Mannitol 40 mg in 0.5 mL lipid emulsion.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
时间窗: Baseline and 24 months
Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration \[area under the curve (AUC), 0-20 minutes\] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
次要结局
- Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months(Baseline and 24 Months)