Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

GAD-Alum

Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

DRUG

GAD-Alum and Aluminum hydroxide

Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.

DRUG

Aluminum hydroxide

Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

Trial Locations (15)

10032

Columbia University, New York

15213

Childrens Hospital of Pittsburgh, Pittsburgh

33136

University of Miami/ Miller School of Medicine, Miami

46202

Indiana University School of Medicine, Indianapolis

55455

University of Minnesota, Minneapolis

80045

Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center, Aurora

90027

Childrens Hospital of Los Angeles, Los Angeles

94143

University of California-San Francisco, San Francisco

94305

Stanford University, Palo Alto

98101

Benaroya Research Institute, Seattle

06520

Yale University School of Medicine, New Haven

Unknown

University of Florida, Gainesville

02215

Joslin Diabetes Center, Boston

75390-8858

University of Texas/Southwestern Medical School, Dallas

M5G 1X8

Hospital for Sick Children, Toronto

Sponsors
All Listed Sponsors
collaborator

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

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Center for Research Resources (NCRR)

NIH

collaborator

American Diabetes Association

OTHER

collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

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

NIH