Neulasta in Type 1 Diabetes

University of Florida

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Dietary Supplement: Mixed Meal Tolerance Test (MMTT); Drug: Neulasta (Pegylated); Drug: Placebo; Other: Blood test; Other: DNA Test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00662519

JDRF 11-2007-825 (Other Grant/Funding Number)

GCRC 683 (Other Grant/Funding Number)

UF IRB 280-2006

1R21DK078863-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Neulasta

Experimental group

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.

Treatment:

Other: DNA Test

Other: Blood test

Dietary Supplement: Mixed Meal Tolerance Test (MMTT)

Drug: Neulasta (Pegylated)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: DNA Test

Other: Blood test

Drug: Placebo

Dietary Supplement: Mixed Meal Tolerance Test (MMTT)