DEFEND-2:Durable-Response Therapy Evaluation For Type 1 Diabetes
Research type
Research Study
Full title
DEFEND-2: Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes
IRAS ID
50465
Contact name
Colin Dayan
Sponsor organisation
Tolerx, Inc
Eudract number
2010-018775-17
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 randomised, multicentre, placebo controlled, double blind study being carried out by Tolerx, Inc., a company that is developing the new drug for patients with autoimmune diseases. Type 1 diabetes is believed to be an autoimmune disease, in which the immune system attacks cells of the pancreas. This study includes patients aged between 12 and 45 years who have recently been diagnosed with type 1 diabetes mellitus and currently require insulin or have required it at some time since the date of diagnosis. The study is designed to see if the new drug called otelixizumab can be used in the treatment of type 1 diabetes. It is believed that otelixizumab might be able to stop the immune system from further attacking the pancreas in people with type 1 diabetes, so that the body can still produce some of its own insulin. The purpose of this study is to compare whether people who have been given otelixizumab can produce more of their own insulin than people who have been given a placebo. This study will be conducted at a large number of hospitals (approximately 200) across a number of countries in Europe and North America and will include about 396 participants. Approximately 36 participants will take part in the UK. Participation will last for approximately 25 months. Participants will be randomised in a 2:1 ratio to otelixizumab or placebo. Participants will receive a series of 8 infusions, 1 infusion per day over 8 consecutive days. Participants will be followed for 24 months after receiving study drug. During the first 12 months, there will be frequent (weekly to monthly) visits; subsequent visits will take place at Months 15, 18, and 24. Unscheduled visits will occur as medically necessary. Participants will undergo procedures including: physical examination, vital signs, blood glucose monitoring, ECG, lab tests, mixed meal tolerance test and questionnaires.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
10/H0803/92
Date of REC Opinion
10 Aug 2010
REC opinion
Further Information Favourable Opinion