Primary Intervention With Mucosal Insulin for Prevention of Type 1 Diabetes in Infants at High Genetic Risk to Develop Diabetes POINT (Primary Oral Insulin Trial) A Dose Finding and Safety Study ( Pre-POINT )
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Blood Glucose Levels
研究概览
简要总结
A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.
Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.
Accrual Objective 25 (3:2 randomization to active and control arms)
详细描述
The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 2 years to 7 years who:
- •Have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs);
- •Type 1 diabetes susceptible HLA DR4-DQB1*0302 or DR4-DQB1*0304 haplotype and
- •None of the following HLA DR or DQB1 alleles:
- •DQB1*0602
- •DR7-DQB1*0303
- •DR14-DQB1*0503 or
- •Have a sibling with T1DM;
- •Identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling;
- •Islet autoantibody negative at time of recruitment.
排除标准
- •Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
- •Prior or current participation in another intervention trial.
- •Chronic oral steroid use and/or other chronic oral immunosuppressant
研究组 & 干预措施
Human Insulin
Oral Insulin at 2.5 mg, 7.5 mg, 22.5 mg, or 67.5 mg per day
干预措施: Human Insulin (Drug)
Placebo
Oral Placebo
干预措施: Oral Placebo (Other)
结局指标
主要结局
Change in Blood Glucose Levels
时间窗: Day 1
Evaluation for hypoglycemia will be measured prior to administration of the insulin (baseline), then at 30, 60, and 120 minutes after administration of the insulin.
Daily Evaluation of Blood Glucose Levels
时间窗: Days 2 through 7
Blood glucose will be measured 60 minutes after the administration of the Insulin.
Evaluation of Blood Glucose Levels
时间窗: Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.
After treatment day 7, Insulin will be administered and measured on a monthly basis.
次要结局
- Change in Total IgE and IgE.(2 weeks, 3 months, 6 months)
- T-cell responses related to potential immune response to Insulin(Day 1, 15 days, 3 and 6 months.)