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Efficacy of Ursodeoxycholic Acid (UDCA) in Patients With Type 2 Diabetes

NCT05416580 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of ursodeoxycholic acid (UDCA) compared to placebo on biomarkers of oxidative stress, inflammation, and endothelial dysfunction in patients with type 2 diabetes mellitus (T2DM) who are treated with metformin but did not meet the target HbA1C \< 7%.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

UDCA (Ursodeoxycholic acid)

UDCA is administered orally in addition to metformin therapy in the recommended doses in patients with type 2 diabetes mellitus.

DRUG

Placebo

Placebo is administered orally in addition to metformin therapy in the recommended doses in patients with type 2 diabetes mellitus.

DRUG

Metformin

Metformin therapy is administered in the recommended dose in patients with type 2 diabetes mellitus.

Sponsors & Collaborators

  • University of Banja Luka

    lead OTHER

Principal Investigators

  • Ranko Skrbic, Professor · University of Banja Luka

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2024-03-31
Completion
2024-04-30

Countries

  • Bosnia and Herzegovina

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416580 on ClinicalTrials.gov