Trial Outcomes & Findings for Butyrate Adjuvant Therapy for Type 1 Diabetes (NCT NCT03999853)
NCT ID: NCT03999853
Last Updated: 2026-03-31
Results Overview
Change in Insulin sensitivity as measured by estimated glucose disposal rate (eGDR), a validated clinical tool for estimating insulin sensitivity in Type 1 Diabetes.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Day 0 to Day 48
Results posted on
2026-03-31
Participant Flow
Participant milestones
| Measure |
Conventional Therapy / Butyrate
Subjects received usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets were taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
BKR-017: BKR-017
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Butyrate Adjuvant Therapy for Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Conventional Therapy / Butyrate
n=6 Participants
Subjects received usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets were taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
BKR-017: BKR-017
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 48Change in Insulin sensitivity as measured by estimated glucose disposal rate (eGDR), a validated clinical tool for estimating insulin sensitivity in Type 1 Diabetes.
Outcome measures
| Measure |
Conventional Therapy / Butyrate
n=6 Participants
Subjects received usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets were taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
BKR-017: BKR-017
|
|---|---|
|
Insulin Sensitivity
Day 0
|
5.71 mg/kg/min
Standard Deviation 2.05
|
|
Insulin Sensitivity
Day 48
|
6.02 mg/kg/min
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Day 0 to Day 48Change in glucose measured by Hemoglobin A1c (HbA1c) which is a blood test that measures blood glucose levels.
Outcome measures
| Measure |
Conventional Therapy / Butyrate
n=6 Participants
Subjects received usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets were taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
BKR-017: BKR-017
|
|---|---|
|
Glucose Variability
Day 0
|
7.1 percentage of hemoglobin
Standard Error 0.2
|
|
Glucose Variability
Day 48
|
6.8 percentage of hemoglobin
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Day 0 to Day 28The change in triglycerides levels was measured through blood samples taken at Day 0 and Day 28.
Outcome measures
| Measure |
Conventional Therapy / Butyrate
n=6 Participants
Subjects received usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets were taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
BKR-017: BKR-017
|
|---|---|
|
Change in Triglycerides
Day 0
|
83.5 mg/dL
Standard Error 9.0
|
|
Change in Triglycerides
Day 28
|
85.2 mg/dL
Standard Error 17.6
|
Adverse Events
Conventional Therapy / Butyrate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Therapy / Butyrate
n=6 participants at risk
Subjects received usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets were taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
BKR-017: BKR-017
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Adverse events were collected from the time of administration of a subject's first dose of test product until study completion, approximately 48 days.
Adverse events were collected through observation and questioning by the study team at every study visit as well as through subject diaries.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Adverse events were collected from the time of administration of a subject's first dose of test product until study completion, approximately 48 days.
Adverse events were collected through observation and questioning by the study team at every study visit as well as through subject diaries.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place