Butyrate Adjuvant Therapy for Type 1 Diabetes


About this study

This study will test the efficacy of BKR-017 (colon-targeted 500 mg butyrate tablets) on insulin sensitivity, glucose control and triglycerides in type-1 diabetes subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/8/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Open for enrollment

Contact information:

Adrian Vella M.D.

(507) 284-1920


More information


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