Inducing Remission in Type 1 Diabetes With Alefacept

PHASE2TerminatedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

April 30, 2014

Conditions
New-onset Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

Alefacept

Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

DRUG

Placebo

Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.

Trial Locations (15)

19104

The Children's Hospital of Philadelphia, Philadelphia

21201

University of Maryland, Baltimore

27713

University of North Carolina, Durham

30322

Emory University, Atlanta

46202

Indiana University, Indianapolis

52242

University of Iowa Hospital & Clinics, Iowa City

64108

Children's Mercy Hospitals and Clinics, Kansas City

68131

Creighton University, Omaha

75390

University of Texas Southwestern Medical Center, Dallas

80045

Barbara Davis Center for Childhood Diabetes - University of Colorado, Aurora

85724

University of Arizona, Tucson

90027

Children's Hospital of Los Angeles, Los Angeles

94143

University of California - San Francisco, San Francisco

98101

Benaroya Research Institute at Virginia Mason, Seattle

02114

Massachusetts General Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

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

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH