R-5280 (HAMS-AB) for Type 1 Diabetes
(R-5280 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, HAMS-AB (Acetylated and Butyrylated High Amylose Maize Starch), for individuals recently diagnosed with Type 1 Diabetes. Researchers aim to assess participants' tolerance to the treatment and identify any side effects. Participants will receive either the actual treatment or a placebo (a harmless pill with no active drug) for 12 weeks. The trial is suitable for children aged 11-17 who have been diagnosed with Type 1 Diabetes within the last two years and maintain a healthy diabetic diet. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications, but it does exclude those who have used steroids or other immunosuppressants in the past six months.
Is there any evidence suggesting that R-5280 (HAMS-AB) is likely to be safe for humans?
Research has shown that R-5280, also known as HAMS-AB, is generally safe for people. Studies have examined its use in individuals with type 1 diabetes, and the treatment appears well-tolerated. Recent research involving young people with type 1 diabetes found no serious side effects. Most participants experienced only mild stomach issues, a common occurrence with prebiotics like HAMS-AB. These findings suggest that R-5280 is a safe option for those considering participation in a clinical trial.12345
Why do researchers think this study treatment might be promising for Type 1 Diabetes?
Unlike the standard of care for Type 1 Diabetes, which typically involves insulin therapy, HAMS-AB, the treatment under study, offers a novel approach by potentially modulating the immune response. Researchers are excited because HAMS-AB is taken orally, which could be more convenient than insulin injections, and it specifically targets immune pathways that may help preserve pancreatic function. This approach is particularly promising because it addresses the underlying autoimmune aspect of Type 1 Diabetes, potentially slowing disease progression.
What evidence suggests that HAMS-AB might be an effective treatment for Type 1 Diabetes?
Research has shown that a special type of starch, called HAMS-AB, might help prevent type 1 diabetes, based on studies with mice. In this trial, participants will receive either HAMS-AB or a placebo. HAMS-AB is a prebiotic, which helps grow healthy bacteria in the gut. A small study with young people recently diagnosed with type 1 diabetes found HAMS-AB to be safe. Although less information is available for humans, these early findings are encouraging. By improving gut health, HAMS-AB might help manage or even slow the progression of type 1 diabetes.12356
Are You a Good Fit for This Trial?
This trial is for children aged 11-17 recently diagnosed with Type 1 Diabetes, who are not overweight and willing to follow a healthy diabetic diet. They can't have other forms of diabetes, ongoing infections or recent antibiotic use, compromised immunity, steroid or immunosuppressant use in the last six months, be pregnant, on high-fiber/vegetarian diets or have certain allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive R-5280 or placebo, taken twice a day orally with food for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HAMS-AB
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rise Therapeutics LLC
Lead Sponsor