EUCTR2012-003251-11-SE进行中（未招募）1 期
Pilot Trial to preserve residual insulin secretion in children and adolescents with recent onset Type 1 diabetes by using GAD-antigen (Diamyd) therapy in combination with Vitamin D and Ibuprofen . - DIABGAD-1
inköping university0 个研究点开始时间: 2012年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent given by patients and guardians/parents
- •Type 1 diabetes according to the ADA classification with < 4 months diabetes duration
- •Age 10.00 -17.99 years at Diagnosis of Type 1 diabetes
- •Fasting C-peptide >0.12 nmol/ml
- •Pos GADA but < 50 000 random units
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- •Continuous treatment with any inflammatory drug ( sporadic treatment eg because of headache or in connection with fever a few days will be accepted)
- •Treatment with any oral or injected anti-diabetic medications other than insulin
- •Treatment with any vitamins, marketed or not, or unwilling to abstain from such medication during the trial.
- •A history of anaemia or significantly abnormal haematology results at screening
- •A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •Clinically significant history of acute reaction to vaccines or other drugs in the past
- •Treatment with any vaccine within 4 months prior to planned first study drug dose or planned treatment with vaccine up to 4 months after the last injection with study drug, including influenza vaccine
- •Participation in other clinical trials with a new chemical entity within the previous 3 months
- •Inability or unwillingness to comply with the provisions of this protocol
- •A history of alcohol or drug abuse
- •A significant illness other than diabetes within 2 weeks prior to first dosing
- •Known human immunodeficiency virus (HIV) or hepatitis
- •Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the GAD-alum treatment)
- •Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last GAD-alum treatment
- •Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.
- •Deemed by the investigator not being able to follow instructions and/or follow the study protocol
研究者
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