EUCTR2019-002692-34-NO进行中（未招募）1 期
A pilot study on safety, feasibility and insulin-promotion by intra-inguinal lymph node injections of glutamic acid decarboxylase (GAD) in patients with LADA type of diabetes.
TNU, Dept of Clinical and Molecular Medicine, Gastrosenteret0 个研究点目标入组 15 人开始时间: 2019年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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.Signed informed consent by the patient.
- •2. Diagnosis of LADA and diabetes debut within the last 18 months before inclusion
- •3.Male or female between 30-70 years of age
- •4.Fasting C-peptide levels = 0.3 nmol/l
- •5.High anti-GAD titers (>190 U/ml)
- •6.Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria
- •7.Antidiabetic medication in the form of metformin is acceptable for inclusion as well as medications not mentioned under exclusion criteria
- •8.Females must agree to avoid pregnancy and have a negative urine pregnancy test.
- •Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of GAD-alum
- •Are the trial subjects under 18? no
- •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 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.Current or previous treatment with immunosuppressant therapy (topical or inhaled steroids are accepted)
- •2.Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- •3.Systemic treatment with glucocorticoids
- •4.Treatment with any vaccine, including influenza vaccine, within 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
- •5.Antidiabetic medication (metformin excepted)
- •6.Significantly abnormal hematology results at screening
- •7.A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •8.Clinically significant history of acute reaction to vaccines in the past.
- •9.Renal disease (as defined by serum creatinine >150 µmol/l)
- •10.Serious cardiovascular events (myocardial infarction, stroke) within the last year preceding recruitment.
- •11.Participation in other clinical trials with a new chemical entity within the previous 3 months
- •12.A history of alcohol or drug abuse
- •13. Known HIV or hepatitis
- •14.Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
- •15.Other serious chronic disease as judged by investigator.
- •16.Females who are lactating, are pregnant or intend to become pregnant.
- •17.Inability or unwillingness to comply with the provisions of this protocol
- •18.Deemed by the investigator not being able to follow instructions and/or follow the study protocol
- •19. Treatment with any other supplementation of vitamin D, marketed or not, or unwilling to abstain from such medication during the 120 days daily intake of Divisun (non-investigational medicinal product)
研究者
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