CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Conjugated bile acids sodium +3 moredrug
Likely dose
Conjugated bile acids sodium 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02871882
NCT02871882Phase 2Completed
CompareCT.gov

Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus

Mayo Clinic·interventional·Posted Aug 18, 2016·Updated May 31, 2023

In Brief

A Phase 2 clinical trial evaluating Gastric Emptying test, Mixed Oral Glucose Tolerance test, and 2 other interventions for Type 2 Diabetes Mellitus and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Obese, Overweight
CountriesUnited States
CollaboratorsSatiogen Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 18, 2016
Enrollment StartSep 15, 2016
Primary CompletionOct 18, 2017
Study CompletionOct 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.9 years ago

Interventions

Gastric Emptying testradiation

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.

Mixed Oral Glucose Tolerance testother

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.

Conjugated bile acids sodiumdrug

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

Placeboother

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