Phase 2
Completed N=20
Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
Source: ClinicalTrials.gov NCT02218619 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Change in C-peptide Measurement as Reflection of Insulin Secretion at 6 Months — -0.07; -0.07 nmol/L*120 min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in C-peptide Measurement as Reflection of Insulin Secretion at 6 Months |
-0.07; -0.07 | — |
| PRIMARY Change in C-peptide Measurement as Reflection of Insulin Secretion at 12 Months |
-0.10; -0.12 | — |
| PRIMARY Change in C-peptide Measurement as Reflection of Insulin Secretion at 18 Months |
-0.11; -0.14 | — |
| SECONDARY Number of Participants With Liver Function Test Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Insulin Use at 6 Months |
-0.10; 0.09 | — |
| SECONDARY Change in Insulin Use at 12 Months |
-0.10; 0.09 | — |
| SECONDARY Change in Insulin Use at 18 Months |
-0.17; 0.02 | — |
| SECONDARY Change in HbA1c at 6 Months |
-0.98; -2.27 | — |
| SECONDARY Change in HbA1c at 12 Months |
-0.02; -2.25 | — |
| SECONDARY Change in HbA1c at 18 Months |
-0.48; -1.89 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02218619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.