NCT01785108已完成2 期
Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen
Johnny Ludvigsson10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30
研究概览
简要总结
The objectives of this study is to
- evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
- evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections
- evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 10 and 18 years of age
- •Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening
- •Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L
- •Elevated GAD65 antibodies (GADA) at time of screening
排除标准
- •Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin
- •A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
- •Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines
- •Participation in other clinical trials with a new chemical entity within the previous 3 months
- •Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose
- •Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
研究组 & 干预措施
GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
Active Comparator
- GAD-Alum (Diamyd) 20 µg given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
- Ibuprofen, 400 mg/day, from Day 1 to Day 90
干预措施: GAD-Alum (Diamyd) 20 µg (Biological)
GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
Active Comparator
- GAD-Alum (Diamyd) 20 µg given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
- Ibuprofen, 400 mg/day, from Day 1 to Day 90
干预措施: Vitamin D (Drug)
GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
Active Comparator
- GAD-Alum (Diamyd) 20 µg given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
- Ibuprofen, 400 mg/day, from Day 1 to Day 90
干预措施: Ibuprofen (Drug)
GAD-Alum (Diamyd) 20µg and Vitamin D
Active Comparator
- GAD-Alum (Diamyd) 20 µg given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
干预措施: GAD-Alum (Diamyd) 20 µg (Biological)
GAD-Alum (Diamyd) 20µg and Vitamin D
Active Comparator
- GAD-Alum (Diamyd) 20 µg given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
干预措施: Vitamin D (Drug)
GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
Active Comparator
- GAD-Alum (Diamyd) 20 µg X 2 given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
干预措施: GAD-Alum (Diamyd) 20 µg X 2 (Biological)
GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
Active Comparator
- GAD-Alum (Diamyd) 20 µg X 2 given twice with one month interval
- Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
干预措施: Vitamin D (Drug)
Placebo
Placebo Comparator
干预措施: GAD-Alum (Diamyd) 20 µg X 2 (Biological)
Placebo
Placebo Comparator
干预措施: Vitamin D (Drug)
Placebo
Placebo Comparator
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30
时间窗: 6 months, 15 months and 30 months
次要结局
- Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L(6, 15 and 30 months)
- Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17(6, 15 and 30 months)
- Hemoglobin A1c (HbA1c), change between baseline and subsequent visits(6, 15 and 30 months)
- Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits(6, 15 and 30 months)
- Th2-deviation of cell-mediated immune response seen, e.g. as increased ratio of IL-5, 10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta, IL-17, and increase of T-regulatory cells(6, 15 and 30 months)
- Fasting C-peptide, change between baseline and month 6, 15 and 30(6, 15 and 30 months)
研究者
Johnny Ludvigsson
MD, PhD, Professor
Linkoeping University
研究点 (10)
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