Butyrate Adjuvant Therapy for Type 1 Diabetes

Mayo Clinic

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Type1diabetes

Treatments: Drug: BKR-017

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03999853

19-006035

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Conventional Therapy / Butyrate

Experimental group

Description:

Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months

Treatment:

Drug: BKR-017