Butyrate Adjuvant Therapy for Type 1 Diabetes

Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes
• Intervention / Treatment: Drug: BKR-017

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Therapy / Butyrate; 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	Drug: BKR-017; BKR-017; Other Names: Butyrate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Sensitivity	Change in Insulin sensitivity as measured by estimated glucose disposal rate (eGDR), a validated clinical tool for estimating insulin sensitivity in Type 1 Diabetes.	Day 0 to Day 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Variability	Change in glucose measured by Hemoglobin A1c (HbA1c) which is a blood test that measures blood glucose levels.	Day 0 to Day 48
Change in Triglycerides	The change in triglycerides levels was measured through blood samples taken at Day 0 and Day 28.	Day 0 to Day 28

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Juvenile Diabetes Research Foundation; BioKier Inc.
• Investigators: Principal Investigator: Adrian Vella, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Butyrate
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Butyrates
• Other Study ID Numbers: 19-006035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No