Butyrate Adjuvant Therapy for Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: BioKier Inc.; Juvenile Diabetes Research Foundation

Criteria

Inclusion Criteria:

1. All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and <80 years of age recruited from the Mayo Clinic Endocrinology Clinic;

2. Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4.

Exclusion Criteria:

1. Except for the use of insulin, no other treatments for T1D will be permitted.

2. Pregnancy

3. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.