Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 12
- 主要终点
- C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
研究概览
简要总结
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine.
The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management.
Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year.
All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.
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
- 6 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 6-45 years
- •Be within 3-months (100 days) of diagnosis of type 1 diabetes
- •Must have at least one diabetes-related autoantibody present
- •Must have stimulated C-peptide levels >0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
- •If participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test during the 12 months of treatment and for an additional 3 months after completing treatment
- •Be at least one month from time of last live immunization received
- •Willing to forgo live vaccinations for 24 months
- •Must be willing to comply with intensive diabetes management
- •Must weigh at least 20 kg (44 lbs) at study entry
排除标准
- •Are immunodeficient or have clinically significant chronic lymphopenia (low white blood cell count)
- •Have an active infection
- •Have a positive PPD test result
- •Be currently pregnant or lactating, or anticipate getting pregnant
- •Ongoing use of medications known to influence glucose tolerance
- •Require use of other immunosuppressive agents
- •Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection
- •Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
- •Be currently participating in another type 1 diabetes treatment study
研究组 & 干预措施
Placebo
Placebo solution given by subcutaneous injection on monthly basis for 12 months
干预措施: Placebo (Drug)
Canakinumab
Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months
干预措施: canakinumab (anti IL-1beta) (Drug)
结局指标
主要结局
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
时间窗: 12 months
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.
次要结局
未报告次要终点