Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
NCT ID: NCT02580877
Last Updated: 2020-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2016-01-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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67.5 mg oral insulin crystals daily
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily
human insulin crystals in capsules
500mg oral insulin crystals every other week
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500mg oral insulin crystals every other week
human insulin crystals in capsules
Interventions
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67.5 mg oral insulin crystals daily
human insulin crystals in capsules
500mg oral insulin crystals every other week
human insulin crystals in capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT
* Confirmed positive for insulin autoantibodies within previous six months
* Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months
Exclusion Criteria
* History of treatment with insulin or oral hypoglycemic agent
* History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months
* Ongoing use of medications known to influence glucose tolerance
* Pregnant or intending to become pregnant while on study or lactating
3 Years
45 Years
ALL
No
Sponsors
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Type 1 Diabetes TrialNet
NETWORK
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Carla Greenbaum, MD
Role: STUDY_CHAIR
Type 1 Diabetes TrialNet
Locations
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University of California - San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Columbia University-Naomi Berrie Diabetes Center
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Benaroya Research Institute
Seattle, Washington, United States
Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria, Australia
The Hospital for Sick Children
Toronto, Ontario, Canada
San Raffaele Hospital
Milan, , Italy
Countries
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References
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Skyler JS, Krischer JP, Wolfsdorf J, Cowie C, Palmer JP, Greenbaum C, Cuthbertson D, Rafkin-Mervis LE, Chase HP, Leschek E. Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1. Diabetes Care. 2005 May;28(5):1068-76. doi: 10.2337/diacare.28.5.1068.
Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P; Pre-POINT Study Group. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. JAMA. 2015 Apr 21;313(15):1541-9. doi: 10.1001/jama.2015.2928.
Jacobsen LM, Schatz DA. Insulin immunotherapy for pretype 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2021 Aug 1;28(4):390-396. doi: 10.1097/MED.0000000000000648.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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