Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Hypoglycemic Events
研究概览
简要总结
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.
详细描述
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.
Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.
By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 1 diabetes who participated in the 1001 study
- •residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.
排除标准
- •The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
- •The subject has a history of any kind of malignant tumor.
- •The subject has clinical evidence of any diabetes-related complication
- •Subject has history of endogenous allergic reactivity:
- •The subject has a known immune deficiency
研究组 & 干预措施
DiaPep277®
Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)
干预措施: DiaPep277® (Drug)
结局指标
主要结局
Hypoglycemic Events
时间窗: At Early Termination Visit, Up to 25 Months
The number of hypoglycemic events recorded by each patient over the course of the study.
次要结局
- Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit(Baseline and Early Termination Visit, Up to 25 Months)