A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 334
- 试验地点
- 65
- 主要终点
- Meal stimulated C-peptide (area under the curve)
研究概览
简要总结
The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.
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
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 10 and 20 years of age
- •Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
- •Fasting C-peptide level at time of screening above 0.1 nmol/L
- •Elevated GAD65 antibodies (GADA) at time of screening
排除标准
- •Treatment with immunosuppressants or any anti-diabetic medications other than insulin
- •A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
- •Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
- •Participation in other clinical trials with a new chemical entity within the previous 3 months
- •Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
- •Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
研究组 & 干预措施
A
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on Days 90 and 270.
干预措施: rhGAD65 (Drug)
B
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on Days 90 and 270.
干预措施: rhGAD65 (Drug)
C
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
干预措施: Placebo (Drug)
结局指标
主要结局
Meal stimulated C-peptide (area under the curve)
时间窗: 15 months
次要结局
- HbA1c(15 months)
- Insulin Dose(15 months)