Dose Optimization of Sitagliptin and Duloxetine in Diabetic Cirrhosis

Trial details

Who runs it

Kafrelsheikh University

Trial code

NCT07439536

Record updated

27 February 2026

Original description

This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on cirrhotic patients with diabetes mellitus and diabetic neuropathy, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A , CP-B, and CP-C) in case of sitagliptin and CP-A in duloxetine at doses corresponding to the closest commercially available strengths to Simcyp®-optimized doses.Read full original descriptionShow less

Evaluation of Model-Guided Dose Adjustment of Sitagliptin and Duloxetine Across Child-Pugh Classes Compared to Non-Cirrhotic Diabetic Patients

This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on cirrhotic patients with diabetes mellitus and diabetic neuropathy, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A , CP-B, and CP-C) in case of sitagliptin and CP-A in duloxetine at doses corresponding to the closest commercially available strengths to Simcyp®-optimized doses.

Clinical evaluation included glycemic parameters(HbA1C,fasting blood glucose,2-hr post prandial glucose level) and pain reduction. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT],and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]),and CBC.

Inclusion: Clinical diagnosis of cirrhosis; Diagnosed with diabetes mellitus; Presence of diabetic neuropathy; Age of patients > 18 years.

Exclusion: Patients with kidney disorder or dialysis; Pregnancy.

ClinicalTrials.gov NCT07439536