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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000039583

Acronym

DAPA-ALT

Enrollment

192

Registered

2024-01-17

Start date

2024-02-01

Completion date

2025-01-31

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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.

Interventions

Patients fulfilling the inclusion criteria of this study and randomized to treatment group would be offered Dapagliflozin/ Metformin 5 mg/1000 mg (5 mg of Dapagliflozin and 1000 mg of Metformin) tablets per oral twice daily treatment for 12 weeks . The treatment will be given as home self administered. Adherence would be monitored by drug tablet return.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age 16 years or older. 2. Gender: Any 3. Patients already diagnosed as having type 2 diabetes mellitus (Fasting blood glucose of >126 mg/dl or HbA1C > 6.5 %) , having suboptimal glycemic control (HbA1C > 7%) on current treatment who are having Alanine Transaminase (ALT)levels > 40IU/L and ultrasonographical features of Non Alcoholic Fatty Liver Disease (NAFLD).

Exclusion criteria

1. Patients with type 1 diabetes mellitus (Sodium-Glucose Co Transporter 2 (SGLT2) inhibitors (SGLT2 inhibitors may precipitate Diabetic Ketoacidosis) 2. Pregnancy (SGLT2 inhibitors not licensed). 3. Patients already on SGLT2 inhibitors 4. Patients having impaired renal function (estimated Glomerular Filtration rate of < 45ml/min/1.73m2), 5. Patients having chronic liver disease, positive viral serology for hepatitis B and C, history of alcohol consumption, having clinical features of hyperthyroidism, recent infections, history of cancer and evidence of gall-stones/cholecystitis on ultrasound, 6. Patients having recent (within 6 months) acute coronary syndrome 7. Cancer of any sort.

Outcome results