SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus

The primary endpoint is liver complications

This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in
 patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic
 liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to
 receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years.
 After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until
 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug
 compliance, physical examination, observed or reported adverse events will be assessed. 10ml
 of blood will be taken at each visit and transient elastography to assess fibrosis regression
 will be performed at 60th month or at withdrawal visit. You are discouraged to use
 (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another
 SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo).