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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Banja Luka
• Treatments: Metformin; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Signed informed consent

• Type 2 Diabetes mellitus verified at least 1 year prior to the study enrollment

• Treatment with metformin at a maximally tolerated dose (up to 2000 mg/day) in patients with an incomplete biochemical response showing HbA1c ≥ 6,5%.

• Body mass index (BMI) corresponding to overweight and obesity (≥ 25 kg/m2)

Exclusion Criteria:

• Insulin treatment within 12 weeks prior to the study enrollment

• Treatment with Glucagon-like peptide 1 (GLP-1) analogs within 12 weeks prior to the study enrollment

• Systemic administration of glucocorticoids continuously for 10 days within 12 weeks prior to the study enrollment

• Prior and concomitant immunosuppressants treatment (other than glucocorticoids)

• History and current serious psychiatric disorders that could affect treatment adherence

• Co-existing uncontrolled cardiovascular disease (i.e arterial hypertension), respiratory insufficiency, acute or chronic renal failure (creatinine clearance < 60 ml/min), and liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, non-alcoholic fatty liver disease, hemochromatosis, and liver failure.

• Known history of cholecystitis

• Pregnant or lactating women

• Known hypersensitivity to UDCA, or other bile acids

• History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening)

• Participation in any other interventional study