Phase 2
Completed N=92
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Source: ClinicalTrials.gov NCT02580877 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Change in GAD65 Autoantibody Titer (DK Units/mL) — 247; 234; 193; 196 DK Units/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in GAD65 Autoantibody Titer (DK Units/mL) |
247; 234; 193; 196 | — |
| PRIMARY Change in mIAA Autoantibody Titer From Baseline |
0.021; 0.020; 0.020; 0.017 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02580877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.