Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

December 31, 2016

Study Completion Date

June 30, 2017

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

Oral Insulin

7.5 mg oral insulin or placebo given before breakfast on a daily basis.

DRUG

Placebo

Placebo capsule designed to match active drug

Trial Locations (18)

3050

Walter and Eliza Hall Institute, Parkville

10032

Columbia University, New York

15213

Childrens Hospital of Pittsburgh, Pittsburgh

20132

San Raffaele Hospital, Milan

33136

University of Miami, Miami

46202

Indiana University-Riley Hospital for Children, Indianapolis

55455

University of Minnesota, Minneapolis

80010

Barbara Davis Center for Childhood Diabetes, Aurora

94143

University of California-San Francisco, San Francisco

94305

Stanford University, Stanford

98101

Benaroya Research Institute, Seattle

06520

Yale University, New Haven

32610-0296

University of Florida, Gainesville

37232-8160

Vanderbilt Eskind Diabetes Clinic, Nashville

75235-8858

University of Texas, Dallas

M5G1X8

The Hospital for Sick Children, Toronto

FIN-20520

University of Turku, Turku

BS10 5NB

University of Bristol, Bristol

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