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| ID | Type | Description | Link |
|---|---|---|---|
| UC4DK106993 | U.S. NIH Grant/Contract | View source | |
| UC4DK117009 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Type 1 Diabetes TrialNet | NETWORK |
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The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
A minimum of 40 eligible participants will be identified for study participation from the TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes and be positive for insulin autoantibodies and at least one other autoantibody. All participants will receive active treatment of recombinant insulin treatment in capsules of either 67.5 mg daily or 500mg every other week. Participants will need to visit the study site up to eleven times over one year for blood tests and other study procedures. During the beginning treatment phase there are two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to baseline. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 67.5 mg oral insulin crystals daily | Experimental | 67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months |
|
| 500mg oral insulin crystals every other week | Experimental | 500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 67.5 mg oral insulin crystals daily | Drug | human insulin crystals in capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in GAD65 Autoantibody Titer (DK Units/mL) | Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response | 13 and 26 weeks after first dose versus baseline |
| Change in mIAA Autoantibody Titer From Baseline | Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response | 13 and 26 weeks after first dose versus baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Greenbaum, MD | Type 1 Diabetes TrialNet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94158-2549 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15855569 | Background | 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. | |
| 25898052 | Background | 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. |
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Data will be available at the NIDDK Central Repository
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 500 mg Oral Insulin Crystals Every Other Week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2016 |
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| 500mg oral insulin crystals every other week | Drug | human insulin crystals in capsules |
|
|
| Stanford |
| California |
| 94305 |
| United States |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80109 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Emory Children's Center | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University-Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Columbia University-Naomi Berrie Diabetes Center | New York | New York | 10032 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Benaroya Research Institute | Seattle | Washington | 98101 | United States |
| Walter and Eliza Hall Institute of Medical Research | Parkville | Victoria | 3050 | Australia |
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| San Raffaele Hospital | Milan | Italy |
| 34091488 | Derived | 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. |
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months 500 mg oral insulin crystals every other week: human insulin crystals in capsules |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Relationship to person with type 1 diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Glucose Tolerance | Count of Participants | Participants |
| ||||||||||||||||
| HLA DR3 | Count of Participants | Participants |
| ||||||||||||||||
| HLA DR4 | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in GAD65 Autoantibody Titer (DK Units/mL) | Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response | Posted | Mean | 95% Confidence Interval | DK Units/mL | 13 and 26 weeks after first dose versus baseline |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change in mIAA Autoantibody Titer From Baseline | Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response | Posted | Mean | 95% Confidence Interval | DK Units/mL | 13 and 26 weeks after first dose versus baseline |
|
|
Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 45 | 0 | 45 | 25 | 45 |
| EG001 | 500 mg 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 500 mg oral insulin crystals every other week: human insulin crystals in capsules | 0 | 47 | 0 | 47 | 24 | 47 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Middle ear inflammation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Endocrine disorders - Other, specify | Endocrine disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Flu like symptoms | General disorders | Systematic Assessment |
| ||
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Systematic Assessment |
| ||
| Anaphylaxis | Immune system disorders | Systematic Assessment |
| ||
| Bronchial infection | Infections and infestations | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Otitis externa | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Psychiatric disorders - Other, specify | Psychiatric disorders | Systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carla Greenbaum, MD | Benaroya Research Institute | 1-800-425-8631 | cjgreen@benaroyaresearch.org |
| Jan 30, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Parent |
|
| Child |
|
| Other |
|
| Abnormal Glucose Tolerance |
|
| Present |
|
| Unknown |
|
| Present |
|
| Unknown |
|
|