Neulasta in Type 1 Diabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00662519

Run by

University of Florida

People needed

21

Starts

2008-04-01

Expected to finish

2014-03-01

Last updated by the study team

2015-04-09

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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