R-5280 in Newly Diagnosed Patients With Type 1 Diabetes (R-5280)

December 6, 2023 updated by: Rise Therapeutics LLC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Not yet recruiting
        • Indiana School of Medicine
        • Contact:
          • Heba Ismail
    • Missouri
      • Kansas City, Missouri, United States, 64118
        • Recruiting
        • Spectrum Clinical Research
        • Contact:
        • Principal Investigator:
          • Evan J Russell, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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.
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
Time Frame: 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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rise Therapeutics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RISE R-5280

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe