Neulasta in Type 1 Diabetes

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Type 1 Diabetes
Interventions
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.

DRUG

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.

OTHER

DNA Test

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

Trial Locations (1)

32610

University of Florida, Gainesville

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Florida

OTHER