Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset)
Conditions
Keywords
Type 1 Diabetes
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
Interventions
DRUGR-5280
Modified Superior Starch
OTHERPlacebo
Food Grade Starch
Sponsors
Rise Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind placebo controlled trial
Intervention model description
Double Blinided, placebo controlled, Phase 1B study.
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance | 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes | 12 Weeks | 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. |
Countries
United States
Outcome results
None listed