Butyrate Adjuvant Therapy for Type 1 Diabetes

Mayo Clinic

Status and phase: Completed; 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 7 weeks of treatment and compared to baseline.

Enrollment: 6 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with T1D and under the care of a healthcare professional for its management
2. HbA1c 6.4-8.9%, inclusive
3. Has given written informed consent to participate in this study
4. Willing to complete 28-day baseline period and 48 -day test period
5. Willing to maintain current diet and exercise routine for the duration of the study
6. Current use of a Dexcom Continuous Glucose Monitor (CGM)

Exclusion criteria

1. History of bariatric or intestinal surgery
2. Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis, or chronic/frequent diarrhea or chronic/frequent constipation
3. Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
4. History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease, or other cardiovascular disease, that in the opinion of the investigator should exclude the subject from the study
5. Severely uncontrolled hypertension at screening defined as a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes
6. Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
7. Active significant infection as determined by the investigator
8. Known allergy to butyrate or any of the components of the tablets
9. Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
10. Pregnant, nursing, or trying to become pregnant
11. Presence of pitting edema on physical exam
12. High fiber diet
13. In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
14. Subject is taking one or more of the excluded therapies.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 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