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Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)

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).

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: 67.5 mg oral insulin crystals daily
  • drug: 500mg oral insulin crystals every other week

Eligibility


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

Ages Eligible for Study

3 Years - 45 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Trudy Esrey
650-498-4450
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