TrialNet Oral Insulin Study

• Research type

  Research Study

• Full title

  ORAL INSULIN FOR PREVENTION OF DIABETES IN PATIENTS AT RISK FOR TYPE 1 DIABETES MELLITUS

• IRAS ID

  20419

• Contact name

  Polly Bingley

• Sponsor organisation

  TrialNet Study Group

• Eudract number

  2006-006550-96

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00419562

• Research summary

  The purpose of this study is to see if giving oral insulin will delay or prevent type 1 diabetes in individuals who are relatives of people with type 1 diabetes and who have autoantibody markers in the blood indicating that they are also at high risk of developing the condition. Previous research suggested that oral insulin may have a beneficial effect in a subgroup of antibody positive relatives who have high levels of insulin autoantibodies as well as islet cell antibodies, but the original study was not designed to explore this. The TrialNet oral insulin study will examine the effect of oral insulin on development of type 1 diabetes in a larger group of relatives in that category.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/83

• Date of REC Opinion

  21 Jan 2010

• REC opinion

  Further Information Favourable Opinion