Efficacy and safety of sitagliptin for the treatment of nonalcoholic fatty liver disease with type 2 diabetes mellitus

Hepatogastroenterology. Mar-Apr 2014;61(130):323-8.


Background/aims: Dipeptidyl peptidase-4 inhibitor is useful for the treatment of type 2 diabetes mellitus (DM). However, effects on liver function and glucose metabolism in nonalcoholic fatty liver disease (NAFLD) have not been established. The objective of this study was to evaluate the efficacy and safety of sitagliptin in NAFLD patients with type 2 DM.

Methodology: Forty-four patients with biopsy-proven NAFLD with type 2 DM were evaluated. Patients were administered sitagliptin (50 mg/day) for 12 months.

Results: Hemoglobin A1c (HbA1c) decreased by 0.7% after treatment (P < 0.001). While HbA1c levels decreased by 0.4% in the low HbA1c (< 7.5%) group, those decreased by 1.2% in the high HbAlc (> or = 7.5%) group. Liver transaminases did not change significantly during the treatment. Improvement of HbA1c (deltaHbA1c) and that of aspartate aminotransferase (deltaAST), alanine aminotransferase (deltaALT) was positively correlated (r = 0.425, and 0.455, respectively), especially in the high HbA1c (> or = 7.5%) group before treatment (r = 0.568, and 0.501, respectively).

Conclusions: Sitagliptin for the treatment of NAFLD with type2 DM was safe and showed similar antidiabetic effects as reported for type 2 DM, suggesting that tight glycemic control would contribute to the improvement of NAFLD based from the findings of correlation between the changes of HbA1c and transaminases.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Fatty Liver / blood
  • Fatty Liver / drug therapy*
  • Female
  • Glycated Hemoglobin A / analysis
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Liver Function Tests
  • Male
  • Middle Aged
  • Non-alcoholic Fatty Liver Disease
  • Pyrazines / adverse effects
  • Pyrazines / therapeutic use*
  • Sitagliptin Phosphate
  • Triazoles / adverse effects
  • Triazoles / therapeutic use*


  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Pyrazines
  • Triazoles
  • hemoglobin A1c protein, human
  • Sitagliptin Phosphate