R-5280 in Newly Diagnosed Patients With Type 1 Diabetes
NCT ID: NCT06057454
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2023-12-05
2025-11-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Comparator
R-5280, Taken Twice a day, orally with food for 12 weeks (84 days)
R-5280
Modified Superior Starch
Placebo Comparator
Food starch, taken twice a day, orally with food for 12 weeks (84 days)
Placebo
Food Grade Starch
Interventions
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R-5280
Modified Superior Starch
Placebo
Food Grade Starch
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
11 Years
17 Years
ALL
No
Sponsors
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Rise Therapeutics LLC
INDUSTRY
Responsible Party
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Locations
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Edward Jenner Research Group LLC
Plantation, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
UTSW Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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RISE R-5280
Identifier Type: -
Identifier Source: org_study_id