Evaluating the effect of Dapagliflozin on Alanine Transaminase Levels in Type 2 Diabetic Patients with Non Alcoholic Fatty Liver Disease

Both Sitagliptin and Dapagliflozin are widely used as adjuncts to Metformin in Type 2 Diabetes Mellitus (T2DM) patients in those having suboptimal glycemic control. It is estimated that Non-alcoholic fatty liver disease (NAFLD) affects approximately more than half of those with T2DM. Hepatic steatosis caused by NAFLD leads to increased levels of hepatic aminotransferases such that alanine aminotransferase (ALT) levels are more than those of aspartate aminotransferase (AST). To our knowledge no study on Dapagliflozin vs Sitagliptin in addition to Metformin has been carried out in Pakistan to see their effect on patients with T2DM and Non Alcoholic Steatohepatitis in terms of improvement of liver enzymes. The objective of this study is therefore to study the effect of Dapagliflozin 10 mg vs Sitagliptin 100 mg in addition to Metformin 2000 mg on ALT levels of T2DM patients who had more than Upper Limit Normal ALT and suboptimal glycemic control and having ultrasonographical evidence of NAFLD. ALT levels of patients who meet the inclusion criteria would be collected at baseline and repeated at 12 weeks interval after treatment with either 10 mg /day of Dapagliflozin or 100 mg/day of Sitagliptin in addition to 2000 mg of Metformin/day. Similarly baseline and 12 weeks post treatment weight, HbA1C levels, Urinary Tract Infections and Genital Mycotic infection of these two groups would be recorded. Any particular difference between these parameters among these two groups would be found after completion of the trial using the statistical methods explained previously.