Type1diabetesPhase 1/2NCT03999853
Butyrate Adjuvant Therapy for Type 1 Diabetes
A Phase 1/2 study testing BKR-017 in people with Type1diabetes, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- BKR-017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 1 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- BKR-017
- Keywords
- Butyrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKR-017Drug
Also called Butyrate tablets
BKR-017
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BKR-017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Day 48
Secondary outcomes (2)
Glucose Variability
Change in glucose measured by Hemoglobin A1c (HbA1c) which is a blood test that measures blood glucose levels.
Measured: 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.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start28 Jul 2022
- Primary completion1 Apr 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- BioKier Inc., Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Adrian Vella, Mayo Clinic
- Investigators
- Adrian Vella, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999853
- Sponsor's protocol ID
- 19-006035
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2019
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects
- ClinicalTrials.gov ID
- NCT03999853
- Acronym / sponsor ID
- 19-006035
- Conditions
- Type1diabetes
- Keywords
- Butyrate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- BioKier Inc., Juvenile Diabetes Research Foundation
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy / Butyrate | Experimental | Drug: BKR-017Subjects 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKR-017Also: Butyrate tabletsBKR-017 | Drug | Conventional Therapy / Butyrate |
Primary outcome
Insulin Sensitivity
Time frame: Day 0 to Day 48
Change in Insulin sensitivity as measured by estimated glucose disposal rate (eGDR), a validated clinical tool for estimating insulin sensitivity in Type 1 Diabetes.
2 secondary outcomes
Glucose Variability
Time frame: Day 0 to Day 48
Change in Triglycerides
Time frame: Day 0 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Vella, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BKR-017 in people with Type1diabetes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Day 0 to Day 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.