Study of the effects of oral insulin on immune response in relatives at risk for type 1 diabetes

Phase 1

• Conditions: Type 1 Diabetes; MedDRA version: 21.1Level: PTClassification code 10066284Term: Diabetes prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001923-30-IT
• Lead Sponsor: TRIALNET COORDINATING CENTER AT THE UNIVERSITY OF SOUTH FLORIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Participant in TrialNet Natural History/Pathway to Prevention Study (TN01) and thus, a relative of a proband with T1D and between the ages of 1-45 at the time of enrollment in TN01.
2. If most recent OGTT demonstrates Normal Glucose Tolerance, participants must be age =3 at time of randomization in this trial.
3. If most recent OGTT demonstrates Abnormal Glucose Tolerance, participants must be age 3-7 at time of randomization in this trial.
4. mIAA confirmed positive within the previous six months.
5. Participant must weigh =12 kg at the time of screening.
6. At least one other diabetes-associated autoantibody present on two separate samples, one of which was drawn within the past six months. Confirmation does not have to involve the same 2 autoantibodies.
7. Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the participant is <18 years of age.
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosed with Diabetes or having their most recent OGTT with fasting glucose =126 mg/dl or 2 hour glucose = 200 mg/dl.
2. Prior participation in clinical research for secondary prevention of T1D.
3. History of treatment with insulin or oral hypoglycemic agent.
4. Current chronic use of medications altering stomach acid (such as H2 blockers, proton pump inhibitors and antacids).
5. History of gastric ulcer or gastric surgery.
6. History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months.
7. 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.
8. 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. Participants on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued.
9. Pregnant, intends to become pregnant while on study, or lactating.
10. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified