Dose Optimization of Sitagliptin and Duloxetine in Diabetic Cirrhosis

This study was a prospective, interventional, two-part pilot clinical study conducted over 3 months on Egyptian cirrhotic patients with diabetes mellitus and diabetic neuropathy. Adult patients aged >18 years with confirmed liver cirrhosis, concomitant diabetes mellitus and diabetic neuropathy were eligible for inclusion. Patients were experienced acute episodes of disease associated with deterioration of hepatic function within 2 months prior to screening, and received concomitant medications known to strongly interact with the study drugs were excluded. In part 1: Sitagliptin dosing was determined based on Simcyp -generated predictions and clinical assessment. 100mg,100 mg, 50 mg, and 50 mg received by control, CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. In part 2: Duloxetine dosing was determined based on Simcyp-generated predictions and clinical assessment. 60 mg ,30 mg received by control, and CP-A cirrhotic patients orally once daily, respectively. 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 criteria

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

Exclusion criteria

• Patients with kidney disorder or dialysis
• Pregnancy