EUCTR2007-002728-13-NL进行中（未招募）不适用
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
Diamyd Therapeutics AB0 个研究点目标入组 320 人开始时间: 2008年6月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •1. Male and female patients between 10 and 20 years of age
- •2. Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
- •3. Fasting C-peptide level at time of screening above 0.1 nmol/L
- •4. Elevated GAD65 antibodies (GADA) at time of screening
- •5. Menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test
- •6. Patients must agree to using adequate contraception, if sexually active, until 1 year after the last study drug administration
- •7. Must be willing to comply with intensive diabetes management
- •8. Written informed consent obtained from the patient and/or patient’s parents or legal acceptable representative(s) according to local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- •2. Treatment with any oral or injected anti-diabetic medications other than insulin
- •3. A history of anemia or significantly abnormal hematology results at screening
- •4. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •5. Clinically significant history of acute reaction to vaccines or other drugs in the past
- •6. 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
- •7. Participation in other clinical trials with a new chemical entity within the previous 3 months
- •8. Inability or unwillingness to comply with the provisions of this protocol
- •9. A history of alcohol or drug abuse
- •10. A significant illness other than diabetes within 2 weeks prior to first dosing
- •11. Known human immunodeficiency virus (HIV) or hepatitis
- •12. 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 investigational product administration)
- •13. Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last study drug administration
- •14. 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.
研究者
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