T1D-Plus
Recruiting closed
An adaptive platform trial by INNODIA – A randomised, adaptive, open label, parallel group, multi-centre platform trial in adults with newly diagnosed type 1 diabetes – T1D-Plus.
Recruiting sites:
- Cardiff and Vale University Health Board
- Cambridge Addenbrookes Hospital
Summary
Trial of new medications in people with Type 1 diabetes aged 18-44 and within 6 weeks of diagnosis.
Aim
Verapamil SR is a known blood pressure lowering drug and has been shown recently to protect and strengthen beta cells and slow down beta cell destruction in T1D. Verapamil SR tablets would be taken once a day orally for 1 year, (increased over the first 3 months from 120 mg to 360 mg).
Golimumab or Simponi is a known treatment for inflammatory forms of arthritis and of the bowel and is administered by sub-cutaneous injection with a short needle every two weeks for 1 year.
ATG or Thymoglobulin is widely used in other medical conditions at much higher doses, e.g. in people receiving organ transplants to help prevent rejection by the immune system. In this trial, ATG is given as an infusion into a vein on two separate intravenous infusions on two consecutive days.
The trial will include 71 patients aged between 18 and 44 years and will investigate whether these medications can stop the damage to the pancreas of people recently diagnosed with type 1 diabetes.
Eligibility to take part
- Age 18-44 years
- Diagnosed with type 1 diabetes in the last 6 weeks.
If you are interested in taking part, please click the “Get Involved” button below:
What will I be asked to do?
After signing the consent form, you will be asked to come in for a screening visit to check if you are eligible for the study. If you are eligible, you will attend for a randomisation visit where it will be decided by chance which study medication you will receive. This is followed by 7 treatment visits, plus an extra optional visit (at the clinic), as well as 3 phone calls (phone visits). The amount of time you will spend at the clinic at each visit may vary. This is because the tests and checks will differ at each visit.
Who is running this study?
The study is being run by Cardiff University, Mackenzie House, Newport Road, Cardiff, CF24 0DE, UK.
It is funded by Breakthrough T1D and the Leona M. and Harry B. Helmsley Charitable Trust.
The Chief Investigator for the study is Professor Colin Dayan, MA, FRCP, PhD, Cardiff University.
