Type 1 Diabetes mellitus

Why is this study being conducted?

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). This study 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.

What are the main eligibility criteria?

Inclusion Criteria:

• Diabetes mellitus Typ 1
• diagnosed  with diabetes before age 40 and started on insulin therapy within 1-year of diagnosis

Exclusion Criteria:

• 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

Important

If you are interested in participating in a clinical trial, please register and you will be contacted by the study coordinator or person involved with the specific trial you are interested in.

• Prior to your participation a physician will inform you about the process in detail and examine if you are eligible to take part in the study.
• If you are to participate all medication will be free.
• Of course you can terminate during the process any time.

References:

Trial information was taken from the following sites:

• http://clinicaltrials.gov/ct2/show/record/NCT00419562?show_locs=Y
  
• In ClinLife opinion the main facts were taken and centralized. ClinLife isn´t liable for defects or wrong translation.
• Official Title: Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus