R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset), Diabetes Mellitus, Type 1

In brief

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Key facts

Study ID

NCT06057454

Run by

Rise Therapeutics LLC

People needed

9

Starts

2023-12-05

Expected to finish

2025-11-05

Last updated by the study team

2025-11-10

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly Diagnosed children (age 11-17 years old)
• BMI <85%
• Diagnosed by ADA criteria with T1D within 2 years
• Accepted to adhere to a healthy diabetic diet as recommended by the ADA

You may not qualify if…

• Monogenic forms of diabetes or type 2 diabetes
• History of ongoing infection or antibiotic treatment within the past four (4) weeks
• History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months
• History of chronic gastrointestinal disease, possible or confirmed celiac disease
• Pregnancy or possible pregnancy
• Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
• Participation in other intervention research trials within the past three (3) months
• Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia)
• Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening)
• Any COVID vaccines within 30 days prior to Day 1

Where it is running

• Edward Jenner Research Group LLC — Plantation, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• UTSW Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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