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NCT02871882

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

Completed Phase 2 Results posted Last updated 31 May 2023
What this trial tests

Phase 2 trial testing Gastric Emptying test in Type 2 Diabetes Mellitus in 24 participants. Completed in 30 October 2017.

Timeline
15 September 2016
Primary endpoint
18 October 2017
30 October 2017

Quick facts

Lead sponsorMayo Clinic
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment24
Start date15 September 2016
Primary completion18 October 2017
Estimated completion30 October 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

Adults 18 to 70, any sex, with Type 2 Diabetes Mellitus or Obese. 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.

Change in Postprandial Glucose Primary · baseline to 1 month

Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal

GroupValue95% CI
Ox Bile Extract-2803-5724 – 1098
Placebo629-4779 – 3814

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Bile acid metabolism and signaling in health and disease: molecular mechanisms and therapeutic targets.
    Fleishman JS, Kumar S. · · 2024 · cited 267× · PMID 38664391 · DOI 10.1038/s41392-024-01811-6
  2. Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.
    Calderon G, McRae A, Rievaj J, Davis J, et al · · 2020 · cited 68× · PMID 32344198 · DOI 10.1016/j.ebiom.2020.102759

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02871882.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing