Adults 20 to 80, any sex, with Type1diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Insulin SensitivityPrimary· 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.
Day 0
Group
Value
95% CI
Conventional Therapy / Butyrate
5.71
± 2.05
Day 48
Group
Value
95% CI
Conventional Therapy / Butyrate
6.02
± 1.92
Glucose VariabilitySecondary· Day 0 to Day 48
Change in glucose measured by Hemoglobin A1c (HbA1c) which is a blood test that measures blood glucose levels.
Day 0
Group
Value
95% CI
Conventional Therapy / Butyrate
7.1
± 0.2
Day 48
Group
Value
95% CI
Conventional Therapy / Butyrate
6.8
± 0.2
Change in TriglyceridesSecondary· Day 0 to Day 28
The change in triglycerides levels was measured through blood samples taken at Day 0 and Day 28.
Day 0
Group
Value
95% CI
Conventional Therapy / Butyrate
83.5
± 9.0
Day 28
Group
Value
95% CI
Conventional Therapy / Butyrate
85.2
± 17.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the time of administration of a subject's first dose of test product until study completion, approximately 48 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06556745 — Pharmacokinetics of Butyrate Tablet BKR-017
· completed
NCT04673656 — Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Dia
· NA
· completed
NCT04279444 — Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03999853.