Defend- 1

• Research type

  Research Study

• Full title

  DEFEND-1: Durable-Response Therapy evaluation for Early or New Onset Type 1 Diabetes

• Contact name

  Anthony Robinson

• Sponsor organisation

  Tolerx Inc

• Eudract number

  2008-002205-40

• ISRCTN Number

  N/A

• Research summary

  Type 1 diabetes is believed to be an auto-immune disease, in which the immune system attacks the body's own cells, specifically the cells of the pancreas (the organ that produces insulin). Otelixizumab is a drug being developed to see if it can be used for the treatment of autoimmune diseases. It is believed that otelixizumab might be able to treat type 1 diabetes by stopping the body from attacking the pancreas.Otelixizumab is a ??monoclonal antibody? which means it is produced in a laboratory as a single antibody with a specific target. It was made to target the cells that stop your pancreas from making insulin. In this study 177 subjects in North America and 95 subjects in Europe with newly diagnosed type 1 diabetes received otelixizumab or placebo. The study drug was delivered directly into the vein over a 2 hour period, on 8 consecutive days. Subjects are being followed for 24 months after receiving study drug. During the first 12 months, there are frequent (weekly to monthly) visits; subsequently visits will occur at Months 15, 18 and 24. The primary objective of the study is to demonstrate that subjects who received an 8 day series of otelixizumab infusions have a greater improvement than subjects who receive placebo in internal insulin secretion.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/43

• Date of REC Opinion

  20 Jan 2009

• REC opinion

  Further Information Favourable Opinion