Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Assessment of MultiPepT1De safety profile
研究概览
简要总结
Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the pancreas are destroyed such that the patient is reliant on injection of insulin to adequately control blood glucose levels for the remainder of his/her life. The autoimmune process targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is a mixture of peptides from islet auto antigens. The mixture has been designed to induce or restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to protect beta-cells
详细描述
Recent onset type 1 diabetes patients will be randomized into 4 groups of 6 subjects and each group will receive 6 injections of either placebo, low, medium or high dose of IMP; each injection is intradermal and spaced 1 month apart.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 1 diabetes
- •Age 18-45 years
- •Maximum of 4 years from diagnosis
- •Evidence of ≥1 autoantibody against β-cell autoantigens
- •Possession of the HLA-DR4 (DRB1*0401) genotype
- •Residual β-cell function (peak C-peptide >200)
排除标准
- •Females who are pregnant, breast-feeding or not using adequate forms of contraception.
- •Use of β-cell stimulants, immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization, any monoclonal antibody therapy given for any indication and any antigen-specific
研究组 & 干预措施
Placebo injection
Water for injection
干预措施: Placebo (Other)
MultiPepT1De injection low dose
Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
干预措施: MultiPepT1De injection (Drug)
MultiPepT1De injection medium dose
Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
干预措施: MultiPepT1De injection (Drug)
MultiPepT1De injection high dose
Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
干预措施: MultiPepT1De injection (Drug)
结局指标
主要结局
Assessment of MultiPepT1De safety profile
时间窗: Every 28 days for 147 days
Safety assessed through measurement and comparison of any reactions or hypersensitivity to MultipepT1De injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests
次要结局
- Assessment of residual beta cell function and markers of metabolic control(24 weeks versus baseline)
- Assessment of T lymphocyte immune response to islet cell antigens(24 weeks versus 12 weeks)