Join Trial Testing New Drug To Slow Type 1 Diabetes Progression Indefinitely
A clinical trial is recruiting children, teens, and adults recently diagnosed with stage 3 type 1 diabetes to test a new drug designed to slow disease progression indefinitely.
Trial Status: Recruiting
Clinical Trials Identifier: NCT07187531
Trial Name: SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes (SAFEGUARD)
Diabetes Type: Type 1 diabetes
Trial Sponsor: SAB Biotherapeutics, Inc.
Why is this study important?
This study is testing the effectiveness of a new antibody drug, SAB-142, for slowing the progression of stage 3 type 1 diabetes, when insulin therapy becomes necessary.
SAB-142 works similarly to Tzield (teplizumab), an approved antibody drug that can delay the onset of type 1 diabetes by an average of two years. However, Tzield is a one-time medication – it cannot be administered again when its effects begin to subside.
Early safety data indicate that SAB-142 can be administered multiple times over a person’s lifetime, suggesting that it could potentially delay type 1 diabetes progression indefinitely. Both SAB-142 and Tzield are antibody drugs administered via infusion. Taking Tzield requires committing to 12 consecutive days of one-hour infusions, while SAB-142 requires only two days to get the full treatment.
That being said, the total time for a single course of treatment ends up being roughly the same. Both days of SAB-142 require 4-6 hours of infusion time. Additionally, researchers are hopeful that people with type 1 diabetes will be able to continue taking SAB-142 twice a year on an indefinite basis. Every subsequent course of SAB-142 requires the same time commitment.
How does the trial work?
Researchers are aiming to recruit 159 participants between the ages of five and 40 who were recently diagnosed with stage 3 type 1 diabetes. All participants agree to receive two courses of SAB-142 six months apart.
Participants will receive a higher or lower dose of SAB-142, or a placebo. The doses are not explicitly stated, but they have been chosen based on results from an earlier trial that provided preliminary evidence of the drug’s safety. The researchers will keep track of any side effects that participants experience in the month following both of their two-day courses of SAB-142.
Over the year following each participant’s initial treatment course, researchers will use several measurements to determine how effectively SAB-142 protects beta cells in the pancreas. Each participant will complete four two-hour mixed meal tolerance tests, one every three months. The researchers will look for changes in C-peptide levels, which are a marker of the ability of the pancreas to make insulin.
Participants will have their A1C, time in range (70-180 mg/dL), and time in tight range (70-140 mg/dL) measured every three months as well. Time in range and time in tight range will also be calculated as the averages of daily CGM data. Time above range, time below range, and hypoglycemic events will also be tracked.
Researchers will also keep track of participants’ insulin doses and look out for anyone who enters the honeymoon phase, when a person’s insulin needs are temporarily reduced. After the initial year concludes, all participants will be eligible for a yearlong extension study, which involves two more treatment courses of SAB-142 spaced six months apart, as well as ongoing testing and monitoring. The people who received a placebo in the initial year will be eligible to receive SAB-142 in the followup year.
Are you interested in participating?
You may be eligible to participate if you are between the ages of five and 40 and:
- Were diagnosed with type 1 diabetes at least 100 days before entering the trial
- Have a C-peptide level of at least 0.2 nmol/L
- Have tested positive for at least one type 1 diabetes-related antibody
People who have already received Tzield or a similar immune system-modifying treatment are not eligible to participate. In addition, people may be ineligible to participate if they have certain severe allergies, other autoimmune diseases, or an elevated risk for infections.
The trial is currently recruiting in locations throughout the U.S., the U.K., Australia, New Zealand, and Europe. See a full list of inclusion/exclusion criteria here.
Learn more about delaying type 1 diabetes here: