T1D-Plus
Research type
Research Study
Full title
T1D-PLUS: 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
IRAS ID
1006723
Contact name
Colin Dayan
Contact email
Sponsor organisation
Cardiff University
ISRCTN Number
ISRCTN45965456
Research summary
This trial is set up within the framework of the INNODIA network - a global partnership between 27 academic institutions, 4 industry partners, a small sized enterprise and 2 patient organisations, bringing their knowledge and experience together in a common goal, to ‘fight type 1 diabetes’ (www.innodia.eu). INNODIA’s overall aim is to advise in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).
INNODIA has established a comprehensive and interdisciplinary network of T1D leading clinical and basic scientist experts in Europe and the United Kingdom (UK), with complementary expertise from the areas of immunology, beta-cell biology, biomarker research and T1D therapy, joining forces with industry partners and two foundations and all major stakeholders in the process. Including regulatory bodies, patients with T1D and their families. The trial will also include sites in the Australasian Type 1 Diabetes Immunotherapy Collaborative in Australia.
T1D occurs when a person’s own immune system attacks their insulin producing cells. Many T1D patients still have 10-20% of their functioning insulin producing cells, when newly diagnosed.
T1D-Plus is a randomised, adaptive, open label, parallel group, multi-centre platform trial in adults (18-44 years) with newly diagnosed T1D. Participants will be randomised to either:
Verapamil alone (once daily dose, which will be escalated in increments of 120mg every month until 360mg is reached) versus
Verapamil + ATG (Infusion. 2.5mg/kg given over 2 days)
OR
Verapamil alone (dose as above) + Golimumab (Simponi) (Subcutaneous injection 50 mg over 12 months).
All patients will receive Verapamil at the same dose.
Participants will attend at 3 monthly intervals for 12 months to monitor their beta cell function via a Mixed Meal Tolerance Test. This involves drinking a liquid meal and measuring the levels of C-Peptide released over a 2-hour period after the meal.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0020
Date of REC Opinion
15 Feb 2024
REC opinion
Further Information Favourable Opinion