A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Stage A Safety: Side effects reported for entire cohort
研究概览
简要总结
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent onset T1D (CDA 2013 guidelines: See link in links section
- •Age 10-18 years
- •Disease Duration 3-30 months
- •Fasting C-Peptide (measured at screening) greater than or equal to 33 pmol/L
- •Post honeymoon phase based on the following criteria: History of HbA1c values and insulin requirements from diagnosis indicating a honeymoon period followed by increased insulin requirements which at time of recruitment are > 0.50 units/Kg together with an HbA1c value > 7.2 %; Patients with diabetes duration > 3 months who never experienced a honeymoon period as reflected by consistent HbA1c values > 7.2 % from the time of diagnosis and at the time of recruitment are using an insulin dose > 0.50 units/Kg.
- •The presence of one or more of the TRPV1 alleles similar to those found in patients currently enrolled in the TRPV1-North American - European Study.
- •Stimulated C-Peptide (measured at mixed meal tolerance at Stage A and Stage B of sP trial) ≥ 200 pmol/L and less than or equal to 1500 pmol/L.
排除标准
- •Patients with known co-morbidities, including ACE-inhibitor treated hypertension as well as chromosomal abnormalities, involving one or more organ systems.
- •Type 2 Diabetes Mellitus
- •Patients with a known radiographic contrast allergy
- •Pregnancy.
研究组 & 干预措施
Substance P - 5nmol/kg
Substance P 5nmol/kg intra-celiac artery, single treatment
干预措施: Substance P (Drug)
Substance P - 15nmol/kg
Substance P 15nmol/kg intra-celiac artery, single treatment
干预措施: Substance P (Drug)
Substance P - 1nmol/kg
Substance P 1nmol/kg intra-celiac artery, single treatment
干预措施: Substance P (Drug)
Substance P - 45nmol/kg
Substance P 45nmol/kg intra-celiac artery, single treatment
干预措施: Substance P (Drug)
结局指标
主要结局
Stage A Safety: Side effects reported for entire cohort
时间窗: Reported during the first 20-27 days following sP administration
To determine if there are unexpected adverse events with intra arterial delivery of sP into the celiac artery in individuals with Type 1 Diabetes, and evidence of residual beta cell function as reflected by a peak C---peptide levels of \> 200 pmol/L. Multiple measurements per patient will be aggregated to arrive at one reported value: Number of participants with abnormal laboratory values, adverse events and/or peak C-peptide levels \>200pmol/L that are related to treatment.
次要结局
- C-Peptide Levels (large cohort)(Day 20-27 post sP injection)
- C-Peptide Levels (small cohort)(Day 20-27 post sP injection)