Neulasta in Type 1 Diabetes

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Placebo; Drug: Neulasta (Pegylated); Dietary Supplement: Mixed Meal Tolerance Test (MMTT); Other: Blood test; Other: DNA Test

• Registration Number: NCT00662519
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-21
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	DNA Test	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.
Neulasta	Blood test	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.
Placebo	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.
Placebo	Mixed Meal Tolerance Test (MMTT)	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.
Neulasta	Neulasta (Pegylated)	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.
Neulasta	Mixed Meal Tolerance Test (MMTT)	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.
Placebo	Blood test	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.
Neulasta	DNA Test	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.	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.
Number of participants with adverse events	96 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States