NCT03999853

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 28, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

June 25, 2019

Results QC Date

February 20, 2026

Last Update Submit

March 11, 2026

Conditions

Type1diabetes

Keywords

Butyrate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Glucose Variability

    Day 0 to Day 48

  • Change in Triglycerides

    Day 0 to Day 28

Study Arms (1)

Conventional Therapy / Butyrate

EXPERIMENTAL

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

Interventions

BKR-017DRUG

BKR-017

Also known as: Butyrate tablets
Conventional Therapy / Butyrate

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of bariatric or intestinal surgery
  • 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
  • Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
  • 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
  • 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
  • Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
  • Active significant infection as determined by the investigator
  • Known allergy to butyrate or any of the components of the tablets
  • 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)
  • Pregnant, nursing, or trying to become pregnant
  • Presence of pitting edema on physical exam
  • High fiber diet
  • 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.
  • Subject is taking one or more of the excluded therapies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Butyrates

Intervention Hierarchy (Ancestors)

Acids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Results Point of Contact

Title
Adrian Vella, M.D.
Organization
Mayo Clinic
Vella.Adrian@mayo.edu
507-266-1387

Study Officials

  • Adrian Vella, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

July 28, 2022

Primary Completion

April 1, 2025

Study Completion

December 1, 2025

Last Updated

March 31, 2026

Results First Posted

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)