Trial Outcomes & Findings for Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin (NCT NCT02033876)
NCT ID: NCT02033876
Last Updated: 2019-05-08
Results Overview
Mixed meal glucose results are used to calculate the area above basal (AAB) for glucose. The glycemic index of a food is defined as the incremental area under the two-hour blood glucose response curve (AUC) following an overnight fast and ingestion of a food with a certain quantity of available carbohydrate (usually 50 g).
COMPLETED
PHASE2
24 participants
baseline, post-treatment approximately 14 - 17 days
2019-05-08
Participant Flow
Participant milestones
| Measure |
Ursodiol
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
Baseline characteristics by cohort
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=39 Participants
|
57 years
n=41 Participants
|
58.9 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
24 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: baseline, post-treatment approximately 14 - 17 daysMixed meal glucose results are used to calculate the area above basal (AAB) for glucose. The glycemic index of a food is defined as the incremental area under the two-hour blood glucose response curve (AUC) following an overnight fast and ingestion of a food with a certain quantity of available carbohydrate (usually 50 g).
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Change in Area Above Basal (AAB) for Glucose
|
66458 mg/dL x min
Interval 53501.0 to 75478.0
|
72566 mg/dL x min
Interval 55654.0 to 93006.0
|
SECONDARY outcome
Timeframe: baseline, post-treatment approximately 14 - 17 daysSerum glucose measurements taken after 10 hours of fasting.
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Change in Fasting Glucose
|
142 mg/dL
Interval 125.7 to 158.8
|
155.7 mg/dL
Interval 126.8 to 166.2
|
SECONDARY outcome
Timeframe: baseline, post-treatment approximately 14 - 17 daysInsulin sensitivity will be calculated by the oral minimal model.
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Change in Insulin Sensitivity
|
19983 mg/dL x minutes
Interval 15260.0 to 28298.0
|
19086 mg/dL x minutes
Interval 13952.0 to 24038.0
|
SECONDARY outcome
Timeframe: post-treatment, approximately 14-17 daysThe time for half of the ingested liquids to leave the stomach. Following a meal with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of liquids was assessed with scintigraphy imaging.
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Gastric Emptying of Liquids (T1/2)
|
63.2 minutes
Interval 50.0 to 78.1
|
63.6 minutes
Interval 50.0 to 73.8
|
SECONDARY outcome
Timeframe: post-treatment, approximately 14-17 daysThe time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served with 50g of Canadian bacon and one slice of bread gastric emptying of solids was assessed with scintigraphy imaging.
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Gastric Emptying of Solids (T1/2)
|
167.5 minutes
Interval 142.7 to 215.4
|
172.3 minutes
Interval 135.3 to 180.9
|
SECONDARY outcome
Timeframe: baseline, post-treatment approximately 14 - 17 daysChange in subject's weight, in kilograms
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Change in Weight
|
93.6 kilograms
Interval 85.7 to 105.4
|
101.9 kilograms
Interval 85.6 to 114.8
|
SECONDARY outcome
Timeframe: baseline, post-treatment approximately 14 - 17 daysChange in subjects BMI, in kilograms per meter squared.
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Change in Body Mass Index
|
33.1 kg/m^2
Interval 29.0 to 38.5
|
32.3 kg/m^2
Interval 30.1 to 37.3
|
SECONDARY outcome
Timeframe: baseline, post-treatment approximately 14 - 17 daysChange in fasting fibroblast growth factor (FGF)-19 expression.
Outcome measures
| Measure |
Ursodiol
n=12 Participants
Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily
Ursodiol
|
Placebo
n=12 Participants
matching placebo capsules to be taken twice daily
Ursodiol
|
|---|---|---|
|
Change in FGF-19
|
52.2 mg/dL
Interval 33.8 to 100.0
|
90.2 mg/dL
Interval 56.8 to 143.5
|
Adverse Events
Ursodiol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place