Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 15, 2016

Primary Completion Date

October 18, 2017

Study Completion Date

October 30, 2017

Conditions
Type 2 Diabetes MellitusObeseOverweight
Interventions
RADIATION

Gastric Emptying test

participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.

OTHER

Mixed Oral Glucose Tolerance test

Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.

DRUG

Conjugated bile acids sodium

500 mg tablets taken orally twice daily for 28 (+/- 4) days

OTHER

Placebo

Placebo tablets taken orally twice daily for 28 (+/- 4) days

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Satiogen Pharmaceuticals, Inc.

INDUSTRY

lead

Mayo Clinic

OTHER