Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months
研究概览
简要总结
This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.
详细描述
The study design is a double blind placebo controlled trial that will enroll subjects between the ages of 8 - 30 who have had the diagnosis of Type 1 diabetes made 4 - 12 months prior to enrollment. A single 14 course of treatment with mAb hOKT3gamma1(Ala-Ala), Teplizumab will be given. The primary endpoint is the C-peptide response to a mixed meal at 12 months. A total of 60 subjects will be enrolled (30 in the drug treatment and 30 in the placebo groups) at 4 study sites: Yale University,the University of California at San Francisco, Children's Hospital of Philadelphia, and the Barbara Davis Diabetes Center.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 8 - 30,
- •duration of diabetes 4 - 12 months,
- •weight greater than 27.5 kg,
- •stimulated C-peptide >= 0.2 pmol/ml
排除标准
- •history of hepatitis C, hepatitis B, HIV
研究组 & 干预措施
1
The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
干预措施: mAb hOKT3gamma1(Ala-Ala), Teplizumab (Drug)
2
Normal saline infusion
干预措施: Placebo Arm (Drug)
结局指标
主要结局
C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months
时间窗: At month 12 post-treatment
C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline.
C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline
时间窗: At Baseline (before treatment)
C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months.
次要结局
- Hemoglobin A1c(At 12 months post-treatment)
- Baseline Hemoglobin A1c(At baseline (before treatment))
- Average Insulin Use Over 12 Months(After 12 months post-treatment)
- Baseline Insulin Use(At baseline (before treatment))