STRIDE

Recruiting until: 31st Dec 2024

A 12-month, randomized, single-blind, placebo-controlled exposure- response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)

Recruiting sites:

  • Cambridge University Hospitals (Cambridge)
  • Ninewells Hospital (Dundee) of the Tayside Health Board
  • Queen Elizabeth Hospital (Birmingham)
  • St George’s Hospital (London)
  • Morriston Hospital (Swansea) of the Swansea Bay University Health Board
  • East Kent Hospitals University, Queen Elizabeth The Queen Mother Hospital (Margate)
  • Norfolk and Norwich University Hospital (Norwich)
  • Dorset County Hospital, Dorset
  • Churchill Hospital (Oxford) – Opening soon
  • Liverpool University Hospitals (Liverpool) – Opening soon
  • Northern Care Alliance, Salford Royal Hospital (Salford) – Opening soon
  • Bradford Royal Infirmary, Bradford – Opening soon

Summary:

Trial of a new medication in people with type 1 diabetes aged 18-45 and within 100 days of diagnosis.

Aim

This study will test whether a drug called Siplizumab might slow or stop the body destroying its insulin producing cells in patients newly diagnosed with Type 1 diabetes.

Eligibility to take part

Male and female patients:

  1. Age 18-45 years
  2. Diagnosed with type 1 diabetes in the last 100 days
  3. Positive for at least 1 diabetes related autoantibody
  4. Using insulin as part of standard care.

If you are interested in taking part, please click the “Get Involved” button below:

What will I be asked to do?

You will be offered a screening visit and be provided with an information sheet describing the study in detail. If you are willing to enter the study, you will have some tests to confirm if you are able to take part. If eligible, you will attend a randomisation visit at which you will have further tests including a mixed meal tolerance test (MMTT) and your first treatment of Siplizumab or placebo. This will be followed by 13 further treatment visits of approximately 1 hour. After treatment, you will attend 3 further visits at weeks 24, 36 and 52, each lasting between 3 and 5 hours.

STRIDE study process

Who is running this study?

Sponsor: ITB-Med

UK Chief Investigator – Professor Mark Evans, Honorary Consultant Physician and Professor of Diabetic Medicine, University of Cambridge, Addenbrookes Hospital