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Neulasta in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Neulasta (Pegylated)

Placebo

Mixed Meal Tolerance Test (MMTT)

Blood test

DNA Test

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neulasta

Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Area Under the Curve C-peptide 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

Secondary Outcome Measures

Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo

Increase T regulatory cells (Treg) from the bone marrow

Full Information

NCT ID

NCT00662519

First Posted

April 16, 2008

Last Updated

April 8, 2015

Sponsor

University of Florida

Collaborators

Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT00662519

Brief Title

Neulasta in Type 1 Diabetes

Official Title

Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neulasta

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Neulasta (Pegylated)

Other Intervention Name(s)

Pegylated granulocyte colony stimulating factor (GCSF)

Intervention Description

Subjects will receive 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline

Intervention Description

Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Mixed Meal Tolerance Test (MMTT)

Intervention Description

This is a 2 hour test to find out how much C-peptide is being produced. C-peptide is used to measure the insulin being made by the cells of the pancreas. Both groups will have this test performed.

Intervention Type

Other

Intervention Name(s)

Blood test

Other Intervention Name(s)

Hemoglobin A1C (HbA1c)

Intervention Description

HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.

Intervention Type

Other

Intervention Name(s)

DNA Test

Other Intervention Name(s)

Human Leukocyte Antigen (HLA)

Intervention Description

The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.

Primary Outcome Measure Information:

Title

Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.

Description

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.

Time Frame

Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.

Title

Number of participants with adverse events

Time Frame

96 Weeks

Secondary Outcome Measure Information:

Title

Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo

Time Frame

96 weeks

Title

Increase T regulatory cells (Treg) from the bone marrow

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Haller, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

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Neulasta in Type 1 Diabetes

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