Oral Insulin for Prevention of Diabetes in People with Family Members with Type 1 Diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Have a proband* with T1DM.
2. If the proband is a sibling, parent, or a child, the study participant must be 3 - 45 years of age. If the proband is a second or third degree relative (i.e. Niece, Nephew, Aunt, Uncle, Grandparent, Cousin), the study participant must be 3-20 years of age.
3. Willing to sign Informed Consent Form.
4. Has normal glucose tolerance on an OGTT performed within 7 weeks prior to randomization. If previous abnormal glucose tolerance, has had two consecutive OGTT with normal glucose tolerance.
5. mIAA confirmed positive within the previous six months.
6. At least one other antibody present on two separate samples, one of which was drawn within the past six months.

* A proband is an individual diagnosed with diabetes before age 40 and started on insulin therapy within 1- year of diagnosis. Probands considered to have type 1 diabetes by their physician who do not meet this definition will be referred to the TrialNet Eligibility Committee.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Does not satisfy the above inclusion criteria.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary, renal, hepatic, immune deficiency and/or disease that is likely to limit life expectancy or lead to therapies such as immunosuppression during the time of the study.
3. Prior participation in a clinical trial for secondary prevention of T1DM.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months.
6. Ongoing use of medications known to influence glucose tolerance, i.e. sulfonylureas, growth hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta adrenergic blockers, niacin. Subjects on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals abnormal glucose tolerance unless two subsequent consecutive OGTT have normal glucose tolerance. Abnormal glucose tolerance is defined as:
• fasting plasma glucose = 110 mg/dL (6.1 mmol/l), AND/OR
• 2 hour plasma glucose = 140 mg/dL (7.8 mmol/l) AND/OR
• 30, 60, or 90 minute plasma glucose = 200 mg/dL (11.1 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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