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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: 67.5 mg oral insulin crystals daily; Drug: 500mg oral insulin crystals every other week

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT02580877

UC4DK117009 (U.S. NIH Grant/Contract)

Oral Insulin-TN20

UC4DK106993 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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. .

Enrollment: 92 patients

Sex: All

Ages: 3 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

67.5 mg oral insulin crystals daily

Experimental group

Description:

67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months

Treatment:

Drug: 67.5 mg oral insulin crystals daily

500mg oral insulin crystals every other week

Experimental group

Description:

500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months

Treatment:

Drug: 500mg oral insulin crystals every other week