Status:
COMPLETED
Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
Lead Sponsor:
Robin Goland, MD
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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 b...
Detailed Description
Reducing endoplasmic reticulum stress will promote beta cell survival in new-onset type 1 diabetes. The primary aim is to test the clinical efficacy of an already approved agent, TUDCA, re-purposed t...
Eligibility Criteria
Inclusion
- Type 1 diabetes according to American Diabetes Association criteria
- Diagnosis of type 1 diabetes within 100 days of randomization
- One positive diabetes-related autoantibody
- Ages 18-45 years
Exclusion
- Drugs known to affect glucose other than insulin
- Stimulated C-peptide levels \< 0.2 pmol/ml measured during a mixed meal tolerance test conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization to either TUDCA or placebo.
- Women during pregnancy
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02218619
Start Date
August 1 2015
End Date
December 31 2019
Last Update
June 5 2025
Active Locations (1)
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1
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave.
New York, New York, United States, 10032