Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

  • STATUS
    Recruiting
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 25 March 2021

Summary

Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

Description

Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).

The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.

Details
Clinical Study IdentifierTX139959
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a proband with T1DM. 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
If the proband is a parent, sibling 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, or half-sibling), the study participant must be 3-20 years of age
Willing to sign Informed Consent Form
OGTT performed within 7 weeks prior to randomization in which
fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
hour plasma glucose < 140 mg/dL (7.8 mmol/l)
mIAA confirmed positive within the previous six months
Two samples with at least one autoantibody other than mIAA positive within the previous six months

Exclusion Criteria

Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no other autoantibodies positive are not eligible for randomization
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
Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin, immunosuppressive drugs
History of treatment with insulin or oral hypoglycemic agent
History of therapy with immunosuppressive drugs or glucocorticoids within the past two years for a period of more than three months
Ongoing use of medications known to influence glucose, 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
Pregnant or intends to become pregnant while on study or lactating
Deemed unlikely or unable to comply with the protocol
OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting Glucose (IFG). Diabetes is defined by
fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by
fasting plasma glucose < 126 mg/dL (7 mmol/l), and
hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l)
IFG is defined by
fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
hour plasma glucose < 140 mg/dL (7.8 mmol/l)
Subject has HLA DQA10102, DQB10602 haplotype
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