Using dapagliflozin to prevent liver complications in patients with chronic hepatitis B and diabetes

Sodium-glucose Co-transporter-2 Inhibitor (SGLT2i) to Prevent of Liver Complications in Patients With Chronic Hepatitis B and Diabetes Mellitus: a Double-blind, Randomised, Placebo-controlled Trial

This study is testing if the diabetes medication dapagliflozin can help prevent liver problems in people with chronic hepatitis B and diabetes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 412 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06364930 on ClinicalTrials.gov

What this trial studies

This clinical trial is a five-year, double-blinded, randomized study comparing dapagliflozin to a placebo in patients suffering from chronic hepatitis B and diabetes mellitus or impaired fasting glucose with compensated advanced chronic liver disease. A total of 412 subjects will be recruited and randomly assigned to receive either dapagliflozin 10mg daily or a placebo for up to five years. Participants will be monitored at regular intervals for drug compliance, adverse events, and liver health assessments, including blood tests and transient elastography to evaluate fibrosis regression. The study aims to determine the efficacy of dapagliflozin in reducing liver complications associated with chronic hepatitis B.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with chronic hepatitis B on specific antiviral therapy and diagnosed with type 2 diabetes or impaired fasting glucose.

Not a fit: Patients with hepatitis C infection, a history of cirrhotic complications, or hepatocellular carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of liver complications and improve outcomes for patients with chronic hepatitis B and diabetes.

How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors in improving liver health, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients with chronic hepatitis B on ETV, TDF or TAF monotherapy for at least 12 months.
2. Known or newly diagnosed type 2 diabetes mellitus (T2D), defined as HbA1c ≥5.7% or fasting blood sugar ≥5.6 mmol/L, or random blood sugar ≥11.1 mmol/L, or 2 hours sugar after oral glucose tolerance test ≥7.8 mmol/L.
3. Stable use of anti-diabetic drugs in the last three months.
4. Presence of compensated advanced chronic liver disease (cACLD) with liver stiffness measurement \>10.0 kPa, or significant portal hypertension (spleen stiffness measurement \> 41.3 kPa), or presence any sign of portal hypertension (e.g. splenomegaly, ascites, varices)
5. Aged 18 years old or above.
6. Written informed consent obtained.

Exclusion Criteria:

1. Patients with hepatitis C virus (HCV) infection as indicated by a positive antibody to HCV (anti-HCV) serology test.
2. Patients with history of cirrhotic complications or hepatocellular carcinoma
3. Patients with organ transplantation
4. Patients receiving a SGLT2i
5. Contraindications to SGLT2i due to renal insufficiency (GFR \< 45 mL/min/1.73m2)
6. Poor glycaemic control with HbA1c \>9.0%
7. Use of multiple anti-diabetic drugs (3 or more)
8. Change in anti-diabetic drugs in the last three months.
9. Serious medical illnesses or malignancy
10. Age \< 18 years
11. No patient consents

Where this trial is running

Hong Kong

• Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Grace LH Wong, MD — Chinese University of Hong Kong
• Study coordinator: Angel ML Chim, MSc

Conditions Chronic Hepatitis B