Dose Optimization of Sitagliptin and Duloxetine in Diabetic Cirrhosis

Summary

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.

Timeline

Start

2024-07-01

Primary completion

2025-07-01

Completion

2025-10-01

Publications

• Results Asakawa M, Mitsui H, Akihisa M, Sekine T, Niitsu Y, Kobayashi A, Miyake A, Hashimoto N, Kawamura M, Ogawa Y. Efficacy and safety of sitagliptin for the treatment of diabetes mellitus complicated by chronic liver injury. Springerplus. 2015 Jul 15;4:346. doi: 10.1186/s40064-015-1135-z. eCollection 2015.

Drugs

Indications