Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.
详细描述
As a participant in this study the following will happen:
Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).
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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be > 12 years old and have a confirmed diagnosis of "recent onset T1D" as defined by:
- •T1D for < 6 months,
- •Stimulated C-peptide ≥ 0.2 pmol/ml
- •Presence of at least one diabetes-related autoantibody (e.g., GAD, IA-2, IAA, ICA)
- •Normal screening values for CBC
- •Willing to comply with intensive diabetes management
- •No history of allergy to GCSF
- •Females having reproductive potential must be willing to avoid pregnancy and have a negative pregnancy test
排除标准
- •Known hypersensitivity to E.Coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
- •Chronic use of steroids or other immunosuppressive agents
- •Active infection
- •Inability to maintain intensive diabetes management
- •Pregnancy
- •History of malignancy
- •Currently participating in another type 1 diabetes treatment study.
- •Use of non-insulin pharmaceuticals that affect glycemic control
研究组 & 干预措施
Neulasta
Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: Neulasta (Pegylated) (Drug)
Neulasta
Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: Mixed Meal Tolerance Test (MMTT) (Dietary Supplement)
Neulasta
Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: Blood test (Other)
Neulasta
Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: DNA Test (Other)
Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: Placebo (Drug)
Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: Mixed Meal Tolerance Test (MMTT) (Dietary Supplement)
Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: Blood test (Other)
Placebo
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test.
干预措施: DNA Test (Other)
结局指标
主要结局
Number of participants with adverse events
时间窗: 96 Weeks
Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
时间窗: Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
The target population distribution of change in the Area Under the Curve in residual beta cell function (C-peptide levels) is the same for treatment and placebo.
次要结局
- Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo(96 weeks)
- Increase T regulatory cells (Treg) from the bone marrow(12 weeks)