NCT01322321撤回2 期
A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
研究概览
简要总结
This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.
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
- 6 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
- •presence of at least one diabetes-related autoantibody
- •qualifying C-peptide value in a mixed meal test at visit 1
- •willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
- •body weight of at least 30 kg
排除标准
- •women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
- •immunodeficiency
- •active infections or febrile illness within 3 days before visit 1
- •major dental work within 8 days before visit 1
- •positive test for tuberculosis at visit 1
- •use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ACZ885
Experimental
干预措施: ACZ885 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
时间窗: at 13 months
次要结局
- Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months(36 months)
- Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months(36 months)
- Measure: number of hypoglycemic events(36 months)
- Measure: daily insulin dose(36 months)
- Measure: anti-ACZ885 antibodies(36 months)
研究者
研究点 (4)
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