R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

Launched by RISE THERAPEUTICS LLC · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called R-5280 for children who have recently been diagnosed with Type 1 Diabetes (T1D). The goal is to see how well R-5280 can help manage this condition and to understand any side effects that might occur. The trial is currently looking for participants aged 11 to 17 who have been diagnosed with T1D within the last two years and who can follow a healthy diet as recommended by diabetes experts.

To be eligible, participants must have a body mass index (BMI) below the 85th percentile and should not have certain other types of diabetes or health conditions. They also need to be healthy overall, without recent infections or specific allergies. Those who join the trial can expect regular check-ups and monitoring while trying out this new treatment, which might help improve their diabetes management. This is an important step toward finding better options for young people living with Type 1 Diabetes.

Gender

ALL

Eligibility criteria

• 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