MELD-ATG
Research type
Research Study
Full title
MELD-ATG: Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D)
IRAS ID
273083
Contact name
Emile Hendriks
Contact email
Sponsor organisation
Universitair Ziekenhuis Leuven (UZ Leuven)
Eudract number
2019-003265-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 20 days
Research summary
People get Type 1 diabetes (T1D) because their immune system, the part of the body which helps fight infections, mistakenly attacks and destroys the beta cells in the pancreas that produce insulin. As the immune system destroys these insulin-producing cells, the body’s own ability to produce insulin decreases, blood glucose levels run high and diabetes develops.
At diagnosis, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin. We call this ‘beta cell function’ and we assess this by measuring C-peptide, which is a protein made by the pancreas when insulin is produced. Most people with T1D eventually stop producing insulin themselves, this may occur rapidly in a few months, or more slowly over several years.The longer people with diabetes can produce their own insulin, the better it is for the control of their blood glucose levels and to avoid long-term complications.
This trial, called MELD-ATG, will see if a drug called anti-thymocyte globulin (ATG), can preserve insulin production in children and young adults, aged between 5 and 25, recently diagnosed with T1D. A study has already been conducted using a low dose of ATG in participants with T1D and has shown low-dose ATG slowed decline of C-peptide. MELD-ATG will be using ATG at the same and lower doses than this study.
We will randomly allocate the different doses of ATG or a placebo, to 114 patients in approximately 10 European countries. Patients and their doctors will not know which group they are in. The ATG or placebo will be given over 2 days. We will then collect blood samples, approximately 10 times over 12 months to compare the C-peptide levels between all the groups to identify the lowest effective ATG dose to slow the decline of C-peptide.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0002
Date of REC Opinion
14 Jan 2021
REC opinion
Favourable Opinion