ATG-GCSF in New Onset Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

August 31, 2017

Study Completion Date

August 31, 2018

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

Anti-Thymocyte Globulin (ATG)

Thymoglobulin

DRUG

Granulocyte colony stimulating factor (GCSF)

Granulocyte colony stimulating factor (GCSF)

DRUG

Placebo (for ATG)

Normal saline administered by IV infusion to mimic ATG

DRUG

Placebo (for GCSF)

Placebo prepared to mimic 6mg subcutaneous injection of GCSF

Trial Locations (13)

10032

Columbia University-Naomi Berrie Diabetes Center, New York

15224

University of Pittsburgh, Pittsburgh

32610

University of Florida, Gainesville

33136

University of Miami, Miami

33612

University of South Florida Diabetes Center, Tampa

37232

Vanderbilt Eskind Diabetes Clinic, Nashville

46202

Indiana University-Riley Hospital for Children, Indianapolis

55455

University of Minnesota, Minneapolis

80045

Barbara Davis Center, Aurora

94305

Stanford University, Stanford

98101

Benaroya Research Institute, Seattle

94158-2549

University of California - San Francisco, San Francisco

06519

Yale University, New Haven

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Center for Research Resources (NCRR)

NIH

collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

American Diabetes Association

OTHER

collaborator

Sanofi

INDUSTRY

collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

collaborator

Amgen

INDUSTRY

lead

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

NIH