Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02580877 |
|
Recruitment Status :
Completed
First Posted : October 20, 2015
Results First Posted : July 27, 2020
Last Update Posted : July 27, 2020
|
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:
Type 1 Diabetes TrialNet
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes | Drug: 67.5 mg oral insulin crystals daily Drug: 500mg oral insulin crystals every other week | Phase 2 |
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. .
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1 |
| Study Start Date : | January 2016 |
| Actual Primary Completion Date : | March 2018 |
| Actual Study Completion Date : | March 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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
|
Drug: 67.5 mg oral insulin crystals daily
human insulin crystals in capsules
Other Name: Humulin R crystals |
|
Experimental: 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
|
Drug: 500mg oral insulin crystals every other week
human insulin crystals in capsules
Other Name: Humulin R crystals |
Primary Outcome Measures :
- Change in GAD65 Autoantibody Titer (DK Units/mL) [ Time Frame: 13 and 26 weeks after first dose versus baseline ]Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response
- Change in mIAA Autoantibody Titer From Baseline [ Time Frame: 13 and 26 weeks after first dose versus baseline ]Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes
- 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:
- Diagnosed with type 1 diabetes
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580877
Locations
Show 19 study locations
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes TrialNet
Investigators
| Study Chair: | Carla Greenbaum, MD | Type 1 Diabetes TrialNet |
Study Documents (Full-Text)
Documents provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Documents provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Study Protocol and Statistical Analysis Plan [PDF] January 15, 2016
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT02580877 |
| Other Study ID Numbers: |
Oral Insulin-TN20 UC4DK106993 ( U.S. NIH Grant/Contract ) UC4DK117009 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 20, 2015 Key Record Dates |
| Results First Posted: | July 27, 2020 |
| Last Update Posted: | July 27, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data will be available at the NIDDK Central Repository |
| URL: | https://repository.niddk.nih.gov/home/ |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
oral insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Insulin Insulin, Globin Zinc Insulin, Isophane Methamphetamine Hypoglycemic Agents Physiological Effects of Drugs |
Central Nervous System Stimulants Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |