TrialNet TN18 Abatacept Prevention
Research type
Research Study
Full title
CTLA-4 Ig (Abatacept) for prevention of abnormal glucose tolerance and diabetes in relatives at-risk for ype 1 diabetes mellitus
IRAS ID
131169
Contact name
Darlene Amado
Contact email
Sponsor organisation
TrialNet Study Group
Eudract number
2013-002249-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117,208, IND
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
The purpose of this study is to see if giving an investigational drug called abatacept will delay or prevent the destruction of beta cells that leads to abnormal glucose tolerance and ultimately type 1 diabetes in people at risk for this disease. Type 1 diabetes is an autoimmune disease. The immune system slowly destroys the beta cells in the pancreas that make insulin until the body is not able to produce enough to regulate blood glucose levels. During this time we can detect markers in the blood. These are called autoantibodies and are a good indicator of risk of progression to type 1 diabetes.
The study is a randomised placebo controlled study. Intravenous abatacept will be administered to participants with diabetes related autoantibodies to see if it will prevent or delay their progression towards diabetes. The endpoint for this study will be development of an abnormal glucose tolerance, meaning that the beta cells are undergoing the process of destruction. The drug will be given 14 times over the course of a year and the participant will be monitored with oral glucose tolerance tests and other blood tests and physical examinations. After the treatment period is complete participants will be followed up until the end of the study with a six monthly OGTTs, interim phone calls and random glucose measurements.REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1061
Date of REC Opinion
11 Sep 2014
REC opinion
Favourable Opinion