DEFEND-1 Long Term Follow Up

• Research type

  Research Study

• Full title

  DEFEND-1 LONG TERM FOLLOW UP:DURABLE-RESPONSE THERAPY EVALUATION FOR EARLY OR NEW ONSET TYPE 1 DIABETES EXTENSION STUDY

• IRAS ID

  64359

• Contact name

  Anthony Robinson

• Sponsor organisation

  Tolerx Inc

• Eudract number

  2010-021259-22

• ISRCTN Number

  N/A

• Research summary

  Type 1 diabetes is an autoimmune disease, in which the immune system attacks and destroys the body's own cells, specifically the insulin producing beta cells found in the pancreas. Insulin is needed by the body to use glucose (sugar). After the beta cells are destroyed, the body cannot produce its own insulin. Instead, the person with type 1 diabetes must inject themselves with insulin to control blood sugar levels. Otelixizumab is a drug being developed to see if it can be used to stop the body from attacking the beta cells. 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 destroy the beta cells of the pancreas. In the DEFEND-1 study 272 patients in North America and Europe with newly diagnosed type 1 diabetes were randomized to receive Otelixizumab or placebo. The patients were administered otelixizumab or placebo for 8 consecutive days and followed for 24 months after receiving study drug. The primary objective of the study was 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. The DEFEND-1 Long Term Follow Up study will continue to observe and assess the subjects for an additional 24 months.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/84

• Date of REC Opinion

  8 Mar 2011

• REC opinion

  Further Information Favourable Opinion