Neulasta in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662519
• Other study ID #: UF IRB 280-2006
• Secondary ID: JDRF 11-2007-825
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2008
• Last updated: April 8, 2015
• Start date: April 2008
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Neulasta (Pegylated)
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.
• Placebo
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.

Dietary Supplement:
• Mixed Meal Tolerance Test (MMTT)
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.

Other:
• Blood test
HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
• DNA Test
The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.	No
Primary	Number of participants with adverse events		96 Weeks	Yes
Secondary	Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo		96 weeks	No
Secondary	Increase T regulatory cells (Treg) from the bone marrow		12 weeks	No