Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20 IEOI)
Number of Subjects in Study Archive: 40
Study Design: Clinical Trial
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1
Duration: January 2016 - present
# Recruitment Centers: 17
Treatment: Oral insulin crystals at varying doses
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20 IEOI) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT02580877
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.
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.
The main objective of this study is to learn more about the immune effects of oral insulin using different doses, and to ascertain additional scientific information about oral insulin and gain a better understanding of how much oral insulin should be given to produce a more favorable immune response that could help delay or prevent T1D.
The primary outcome measure is change in Immune Function (from 13 and 26 weeks after first dose versus baseline), assessed by level or quality of T-lymphocyte or autoantibody biomarkers of beta cell specific immune response as measured by change in: CD4 auto-antigen specific ELISPOTs for IFN-g and IL-17, and cD8 peptide-HLA multimers (Q-dots).
Subjects must be participants in TrialNet Natural History/Pathway to Prevention Study (TN01); be a relative of a proband with type 1 diabetes; be between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT; be confirmed positive for insulin autoantibodies within previous six months; and be confirmed positive for one or more other autoantibodies on two separate occasions within the past six months.
Subjects that have been diagnosed with type 1 diabetes; have a history of treatment with insulin or oral hypoglycemic agent; have a history of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months; have ongoing use of medications known to influence glucose tolerance; or be pregnant or intending to become pregnant while on study or lactating.
This study is ongoing.