NCT00456027已完成2 期
A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)
Diamyd Therapeutics AB19 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2004年12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
- 160
- 试验地点
- 19
- 主要终点
- The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement.
研究概览
简要总结
This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years
- •Presence of GAD65 antibodies
- •Detectable C-peptide level
- •Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)
- •Written informed Consent
排除标准
- •Treatment with insulin
- •Intolerance to OHA
- •Secondary diabetes mellitus
- •History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis)
- •Treatment with any vaccine within one 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
- •Pregnancy (or planned pregnancy within one year after 2nd administration)
- •Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
- •Significant illness other than diabetes within 2 weeks prior to first dosing
- •Unwillingness to comply with the provisions of the protocol
- •Clinically significant history of acute reaction to drugs in the past
- •Treatment with immunosuppressants
结局指标
主要结局
The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement.
时间窗: 30 months
次要结局
未报告次要终点
研究者
研究点 (19)
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