Neulasta in Type 1 Diabetes

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborators: Juvenile Diabetes Research Foundation; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Lenograstim; Sargramostim

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