Rezpegaldesleukin for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called rezpegaldesleukin for individuals recently diagnosed with Type 1 Diabetes (T1D). The goal is to determine if this treatment can improve blood sugar management through medication administered every two weeks. Participants will receive either the actual treatment or a placebo (a harmless substance with no therapeutic effect) for comparison. The trial seeks individuals diagnosed with T1D within the last 100 days who are willing to manage their diabetes closely and meet specific health criteria, such as having certain diabetes-related antibodies. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop using non-insulin medications that affect blood sugar levels within 7 days before the screening visit. You also cannot be on systemic immunosuppressive drugs, but inhaled or topical steroids are allowed.
Is there any evidence suggesting that rezpegaldesleukin is likely to be safe for humans?
Research has shown that rezpegaldesleukin has undergone testing in humans. Early results from these studies indicate that the treatment is generally well-tolerated. In another study, participants experienced positive outcomes without major side effects, suggesting that serious problems are uncommon.
Rezpegaldesleukin boosts certain immune cells, but the treatment remains under investigation. Some unknowns about its long-term safety persist. However, the current safety data is encouraging, and its repeated testing in humans is a positive indicator of its safety.12345Why do researchers think this study treatment might be promising for diabetes?
Rezpegaldesleukin is unique because it uses a novel mechanism of action, targeting the immune system differently than standard diabetes treatments like insulin or metformin. Unlike these common treatments, which typically focus on managing blood sugar levels directly, rezpegaldesleukin is designed to work by modulating the immune response. This approach could potentially address the root causes of diabetes and offer a new avenue for managing the condition. Researchers are excited about its potential to provide long-lasting benefits with a convenient subcutaneous injection, which could simplify treatment regimens for patients.
What evidence suggests that rezpegaldesleukin might be an effective treatment for diabetes?
Research has shown that rezpegaldesleukin, which participants in this trial may receive, increases the number of regulatory T cells. These immune cells help calm the immune system, which is crucial for conditions like Type 1 Diabetes, where the immune system mistakenly attacks the body's insulin-producing cells. Studies have found that rezpegaldesleukin reduces inflammation and improves symptoms in diseases like asthma and atopic dermatitis. These findings suggest it might also protect insulin-producing cells in Type 1 Diabetes. Although more research is needed, early results are promising for its potential to manage this condition.14678
Are You a Good Fit for This Trial?
This trial is for people aged 8-45 who've been diagnosed with Type 1 Diabetes within the last 100 days. They must have a certain level of C-peptide, weigh within specific limits, and manage their diabetes well. Participants need to test negative for CMV/EBV viruses and not show symptoms of these infections recently.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rezpegaldesleukin or placebo via subcutaneous injections every 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rezpegaldesleukin
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor