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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: Type 1 Diabetes TrialNet
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Methamphetamine

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