R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

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

Detailed Description
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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

Official Title
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Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

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

Intervention / Treatment
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* Drug: R-5280
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blinided, placebo controlled, Phase 1B study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>R-5280, Taken Twice a day, orally with food for 12 weeks (84 days) | Drug: R-5280<br>* Modified Superior Starch<br>|
| Placebo Comparator: Placebo Comparator<br>Food starch, taken twice a day, orally with food for 12 weeks (84 days) | Other: Placebo<br>* Food Grade Starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance | The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes | To measure the levels of glucose (in milligrams) in the blood at the beginning and again at 12 weeks, and the measurement of C-Peptide (in nanograms) in the blood at the beginning and again at 12 weeks versus placebo, changes in the type of gut bacteria at the beginning and again at 12 weeks versus placebo. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes