Which Intervention Works at Which Disease Stage?
The trials target different stages of this autoimmune disease – from a high risk of developing the condition to a recent diagnosis – and share a common goal: to slow the loss of insulin-producing beta cells.
In doing so, they bring findings from diabetes research directly into clinical application in patients. That this path can lead from research all the way to an approved therapy is illustrated by teplizumab, an agent that has been approved in Germany since January 2026.
The rationale behind all four trials is the same: large studies have shown that protecting and preserving beta-cell function is one of the most important immunomodulatory therapeutic targets in type 1 diabetes.
The clinical trials translate this insight into concrete treatment approaches – and, for the different disease stages, test which intervention can take effect at the right point in time.
Baricitinib – Protecting the Beta Cells
BARICADE DELAY and BARICADE PRESERVE are evaluating baricitinib, a Janus kinase (JAK) inhibitor already used in a range of autoimmune diseases. An earlier study showed that, following the onset of type 1 diabetes, baricitinib can preserve the function of insulin-producing beta cells for longer. These findings are now being advanced toward clinical application in two Phase 3 trials.
The two trials investigate whether the onset or progression of type 1 diabetes can be slowed with baricitinib:
- BARICADE DELAY examines whether, in individuals at high risk of type 1 diabetes (stage 1b or stage 2), baricitinib can delay or prevent the onset of clinical type 1 diabetes. This is a Phase 3 clinical trial.
- BARICADE PRESERVE investigates whether, in people with newly diagnosed type 1 diabetes, baricitinib can slow the progressive destruction of beta-cell function. This trial is likewise in Phase 3.
Further Immunomodulatory Approaches in Clinical Testing
As part of the INNODIA network, the study center is additionally involved in two new immunomodulatory trials, the SAFEGUARD and βETA PRESERVE trials. Both evaluate different agents with the aim of preserving beta-cell function for as long as possible after a diagnosis of type 1 diabetes, thereby enabling more favorable treatment – here, too, the focus is on translating promising approaches into clinical application.
- The SAFEGUARD trial investigates whether the drug SAB-142 can slow the loss of insulin-producing cells in the pancreas. This trial is in Phase 2b.
- The βETA PRESERVE trial examines whether the agent teplizumab leads to improved glycemic control and whether it enables people with type 1 diabetes to require less insulin. Teplizumab has been approved since January 2026 and may help preserve the body’s own insulin production for longer. This is a Phase 3 clinical trial.
Who Can Take Part in the Trials?
Families and other interested individuals can find detailed information on inclusion and exclusion criteria on the respective trial websites. Some key points:
- BARICADE DELAY: individuals aged 2–35 at high risk of type 1 diabetes
- BARICADE PRESERVE: individuals aged 2–35 diagnosed with type 1 diabetes within the past 3 months
- βETA PRESERVE: individuals aged 1–25 diagnosed with type 1 diabetes within the past 2 months
- SAFEGUARD: individuals aged 12–40 diagnosed with type 1 diabetes within the past 100 days
Further clinical trials on type 1 diabetes can be found at diabinfo.de.
BARICADE DELAY and BARICADE PRESERVE are conducted by Eli Lilly and Company, the βETA PRESERVE trial by Sanofi, and the SAFEGUARD trial by SAB Biotherapeutics.
Clinical Trials: The Path from Research to Therapy
Learn more about how Helmholtz Munich, together with clinical partners, deliberately translates research findings into new therapies:
