CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Tauroursodeoxycholic Acid (TUDCA) +1 moredrug
Likely dose
Tauroursodeoxycholic Acid (TUDCA) 1750 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/NCT02218619
NCT02218619Phase 2Completed

Clinical Investigation of Efficacy of Tauroursodeoxycholic Acid (TUDCA) to Enhance Pancreatic Beta Cell Survival In Type 1 Diabetes by Reducing Endoplasmic Reticulum Stress

Robin Goland, MD·interventional·Posted Aug 18, 2014·Updated Jun 5, 2025

In Brief

A Phase 2 clinical trial evaluating Tauroursodeoxycholic Acid (TUDCA) and Sugar Pill (placebo) for Type 1 Diabetes. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major pathological basis for the disease, has led to efforts to prevent or suppress this immune assault. Here the investigators propose to buttress the beta cell's capacity to withstand this assault by improving the function of the endoplasmic reticulum stress resolving mechanisms within these cells. The ability to do so could have a major impact on preventive and therapeutic strategies for type 1 diabetes (and possibly other types of diabetes). The type of endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be applied on an anticipatory basis to individuals at high risk for type 1 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 18, 2014
Enrollment StartAug 1, 2015
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.9 years ago

Interventions

Tauroursodeoxycholic Acid (TUDCA)drug

TUDCA at 1750 mg/day x 12 months

Sugar Pill (placebo)drug

Placebo