Exploring Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus TN20
- CTRC Outpatient
- UT Southwestern Ambulatory Services
This is a 2-arm, multicenter, randomized, open-labeled clinical research study. Participants will received varying doses and schedules of recombinant human insulin in capsules, (oral insulin). each participant is randomly assigned to 1 of 2 treatment regimens with equal probability. The primary outcome is the change in immunologic parameters before and after treatment. The treatment period is 6 months.
The protocol will enroll at least 40 participants who will be randomly assigned to the following groups:
20 assigned to receive oral insulin (67.5 mg daily)
20 assigned to receive oral insulin (500 mg every other week). Those randomized to this treatment will receive a titrated dose from 135 mg at Baseling, followed by 250 mg two weeks later, then dosing at 500 mg two weeks after that is well tolerated.
We will examine changes in immunologic biomarkers in treatment-naive and treatment -responsive participants following introduction of oral insulin as above.
Mechanistic assays will determine the presence of auto-reactive T-cells, and induction of T-Regulatory Cells.
additional outcomes include safety measures and disease progression assessed by regular glucose tolerance testing.
Potential participants must meet all the following inclusion criteria prior to randomization:
1. Participants in TRIALNET Pathway to Prevention Study (TN01), and thus, a relative of a someone with T1D and between ages 1-45 at time of enrollment in TN01.
2. Most recent OGTT demonstrates Normal glucose tolerance, participants age >3 at time of randomization in this trial
3. Most recent OGTT demonstrates Abnormal glucose tolerance, participants must be age 3-7 at time of randomization in this trial.
4. mIAA confirmed positive within previous 6 months.
5. Participant must weigh >12 Kg at time of randomization to the trial.
6. At least one other diabetes-associated autoantibody present on 2 separate samples, one being drawn within the past 6 months.
7. Willing to provide informed consent or have a parent or legal guardian provide informed consent if age is less than 18 years old.