R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— R-5280  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057454
• Other study ID #: RISE R-5280
• Status: Recruiting
• Phase: Phase 1
• Start date: December 5, 2023
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: Rise Therapeutics LLC
• Contact: Janet Stephens, PhD
• Phone: 6504178556
• Email: jstephens[@]risetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• R-5280
Modified Superior Starch

Other:
• Placebo
Food Grade Starch

Locations

Country	Name	City	State
United States	Indiana School of Medicine	Indianapolis	Indiana
United States	Spectrum Clinical Research	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Rise Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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