SAFEGUARD Study

Type 1 diabetes (T1D) happens when the immune system attacks the cells in the pancreas that make insulin. A treatment called anti-thymocyte globulin (ATG), made from animal proteins, has been shown to help protect these insulin-making cells in people recently diagnosed with T1D.

The most common side effect of ATG is flu-like symptoms. This study is testing a new human version of ATG. It is designed to work like the older treatment but with fewer side effects.

The SAFEGUARD study is inviting people who have recently been diagnosed with type 1 diabetes to join this clinical trial and test how well this new treatment works.

The SAFEGUARD study involves two treatment periods, over two days each. Once at the beginning and again about six months later. The study treatment will be given through a vein in the arm, and each treatment will last 4 to 6 hours per day.

To monitor participants closely, there will be five in-person clinic visits and three phone check-ins throughout the year. At each visit, the team will monitor participants’ blood sugar levels, insulin production, and overall health to ensure the treatment is safe and effective.

If successful, the study treatment may help protect insulin-producing cells and preserve the body’s natural insulin production.

Participants must be:

• People aged between 16 and 40 years initially (under 16 will open soon)
• Diagnosed with type 1 diabetes in the last 100 days
• Currently trial sites are open in Victoria, New South Wales (Australia) and Auckland (New Zealand)

Trial site locations:

• Australia
  • Melbourne
  • Sydney
  • Perth
  • Brisbane
• New Zealand
  • Auckland
  • Wellington
  • Christchurch
  • Otago
  • Hamilton

If you have any queries, please contact the ATIC coordinating team – atic@svi.edu.au / 03 9231 2480. 

further information on this study, click here.

Ethics approval for this study was received from the St Vincent’s Hospital Melbourne   Human Research Ethics Committee: HREC 219/25