Clinical Trial

Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

Study acronym: HHTN
Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.
Trial Details
NCT Number NCT06449833
Lead Sponsor Zhujiang Hospital
Conditions Type2 Diabetes Mellitus, Nonalcoholic Fatty Liver Disease
Enrollment 100 participants
Start Date 2024-06
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2024-06-10