In addition to funding research, a key component of Breakthrough T1D’s research strategy is the promotion and knowledge translation of clinical trials. Here we report on recent results from international trials relevant to our type 1 diabetes (T1D) community.
To see if there is actively recruiting research that you can be part of, see our T1D Clinical Trial Finder.
Cell Therapy: Tegoprubart trial
Current islet transplantation (from cadaveric donor islets in clinical practice to stem cell derived islets in clinical trials) require immunosuppression to protect the islets from the recipients’ immune system. Dr. Piotr Witkowski (University of Chicago) is investigating the use of tegoprubart as a less toxic alternative to commonly used tacrolimus for people with T1D receiving cadaveric donor islet transplants.
Tegoprubart (AT-1501) is an anti-CD40L antibody owned by Eledon Pharmaceuticals and has shown promising safety and efficacy data for kidney transplants.
In the ongoing islet replacement trial, preliminary data on the first six subjects show that tegoprubart is able to protect the transplanted cadaveric donor islet cells. All six transplanted subjects demonstrated marked improvements in glycemic control, achieving and maintaining insulin independence after one or two islet transplants.
Tegoprubart was generally well tolerated, with no reported serious adverse events and no signs of the kidney or neurological toxicity often observed with traditional immunosuppression.
This clinical trial is partly funded by Breakthrough T1D International and Eledon Pharmaceuticals is funded by the Breakthrough T1D Fund.
Disease-modifying therapy: PETITE-T1D
Disease-modifying therapies address the underlying cause of T1D, meaning that they protect beta cells, stop the autoimmune attack, or both.
Sanofi’s PETITE-T1D trial is testing the efficacy and safety of Tzield in kids aged 0-7 with early-stage T1D. Tzield is currently approved by Health Canada for children and adults aged eight and older with stage 2 T1D, in whom it can delay the onset of stage 3 T1D by a median of 3 years.
Interim results from PETITE-T1D show that the safety profile of Tzield in children under the age of 8 is similar to that of older individuals who receive the drug. This study is ongoing, and we look forward to seeing efficacy data (how well it is reducing the autoimmune attack) in 2026.
Disease-modifying therapy: TrialNet Abatacept Prevention Study
New analysis from TrialNet on abatacept’s impact on type 1 diabetes progression suggest that further investigation may be warranted.
Abatacept (brand name Orencia®) is a prescription biologic medication that is used to treat certain autoimmune diseases. It works by blocking the activation of T-cells, a type of immune cell that causes inflammation,
The Abatacept Prevention Study first opened in 2013 and enrolled 212 people between the ages of 6 and 45. All participants had at least one relative with T1D and were identified as being Stage 1 T1D (which means they had two or more diabetes-related autoantibodies but normal glucose tolerance).
The initial study analysis found that while abatacept impacted immune response and preserved insulin production during the one-year treatment period, it did not meet the study goal of delaying progression to abnormal glucose tolerance (stage 2 T1D) or clinical diagnosis of T1D (stage 3 T1D). The group treated with abatacept maintained beta cell function better than the placebo group at 12 months. In addition, known effects of abatacept were detected on immune cells. However, 12 months after treatment ended, beta cell function was the same for both groups and effects on immune cells had reversed. The early effect was not sustained.
In a re-analysis of the data, it was found that the participants who were secreting the most insulin at the start of the trial had the most benefit from Abatacept. This is the first indication that an immune intervention in stage 1 T1D may delay disease progression in a subset of individuals. As studies into disease-modifying therapies sig deeper into why certain people respond better than others, it is becoming clear that a precision medicine approach will be needed to get people the most beneficial therapy possible.
Kidney complications: Finerenone
In November 2025 Bayer shared data from the international phase 3 clinical trial (FINE-ONE) which included participating sites across Canada. These results showed that finerenone (Kerendia™/Firialta™) significantly reduces urine albumin-to-creatinine ratio, a measure of kidney damage, in people with chronic kidney disease (CKD) associated with T1D.
In CKD, the hormone aldolsterone is overactive, leading to kidney damage. Finerenone blocks this hormone’s activity to protect the kidneys from further damage. Finerenone has already been approved for the treatment of CKD in type 2 diabetes.
Finerenone was well-tolerated, with no new safety issues reported and few serious adverse events. Based on these results, Bayer intends to submit the data for regulatory review, with the goal of expanding finerenone’s indication to include treatment of CKD in people living with T1D.
CKD is one of the most common complications of T1D. Nearly a third of people living with T1D will develop CKD, increasing the risk of both kidney failure and cardiovascular disease.
Finerenone is the first therapy in three decades to achieve positive outcomes for CKD in people with T1D.
Breakthrough T1D strategically collaborated with Bayer to support the FINE-ONE clinical trial.
Devices in Pregnancy: CIRCUIT Trial
To assess the efficacy of a closed-loop system in pregnancy, a randomized clinical trial in Canada and Australia, enrolled pregnant women with T1D before 14 weeks’ gestation, with follow-up until 6 weeks postpartum.
They analyzed 88 participants who were randomly assigned by 16 weeks’ gestation to closed-loop therapy or standard care. The standard care group continued their pre-randomization insulin delivery method (multiple daily injections or insulin pump), and all participants used continuous glucose monitoring throughout the study.
The mean percentage of time in the pregnancy-specific glucose range was significantly higher in the closed-loop group (65.4% TIR) than in the standard care group (50.3% TIR); the adjusted mean glucose level was also lower in the closed-loop group than in the standard care group.
The findings support the use of closed-loop systems in pregnancy with T1D.
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Breakthrough T1D Canada will continue to monitor the results of these trials and share more updates as they become available.
