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 Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 72
- 主要终点
- Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months
研究概览
简要总结
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.
Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of type 1 diabetes within last 6 months
- •Age 20-45 years
- •fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
- •BMI between 17 and 30 at screening
排除标准
- •Significant disease or condition other than type 1 diabetes
- •Diabetes-related complications
- •Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
研究组 & 干预措施
DiaPep277
Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
干预措施: DiaPep277 (Drug)
Placebo
Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
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
Change in Beta-cell function, measured as stimulated C-peptide secretion 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
- Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%(24 and 25 months)
- Frequency of Hypoglycemic Events(Baseline to 25 Months)
- Mean Number of Days With at Least One Hypoglycemic Event(Baseline to 25 months)