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Butyrate Adjuvant Therapy for Type 1 Diabetes | Clinical Trials | Clareo Health

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COMPLETEDPhase 1/2NCT03999853

Butyrate Adjuvant Therapy for Type 1 Diabetes

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.

Lead sponsor: Mayo Clinic•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Mayo Clinic

Collaborators

BioKier Inc.
Juvenile Diabetes Research Foundation

This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in this population. Insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 7, 2026Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1/PHASE2

Enrollment6

Start dateJul 2022

Last updatedJan 7, 2026

Condition

Locations shown

Mayo Clinic in Rochester

Rochester, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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