NCT00435981已完成2 期
A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus
Diamyd Therapeutics AB16 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase).
研究概览
简要总结
This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.
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
- Double
入排标准
- 年龄范围
- 10 Years 至 18 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 18 years of age, diagnosed with type 1 diabetes within 18 months
- •Fasting C-peptide level above 0.1 nmol/l
- •Presence of GAD65 antibodies
- •Written informed consent (patient and parent/guardian)
排除标准
- •Secondary diabetes mellitus or MODY
- •Treatment with immunosuppressants
- •Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
- •Participation in other clinical trials with a new chemical entity within the previous 3 months
- •History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse)
- •HIV or hepatitis
- •Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
- •Pregnancy (or planned pregnancy within one year after 2nd administration)
结局指标
主要结局
To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase).
次要结局
- To evaluate the safety of Diamyd® 20ug.
研究者
研究点 (16)
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