Status:
COMPLETED
R-5280 in Newly Diagnosed Patients With Type 1 Diabetes
Lead Sponsor:
Rise Therapeutics LLC
Conditions:
Type 1 Diabetes
Type 1 Diabetes (Juvenile Onset)
Eligibility:
All Genders
11-17 years
Phase:
PHASE1
Brief Summary
Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Detailed Description
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06057454
Start Date
December 5 2023
End Date
November 5 2025
Last Update
November 7 2025
Active Locations (3)
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1
Edward Jenner Research Group LLC
Plantation, Florida, United States, 33317
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
UTSW Medical Center
Dallas, Texas, United States, 75390