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

Sponsor
Zhujiang Hospital
Study ID
NCT06449833
Phase
PHASE4
Status
Recruiting
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Conditions

  • Nonalcoholic Fatty Liver Disease
  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Henagliflozein and Metformin — DRUG
    The experimental group will be treated with 10mg Henagliflozein and Metformin.
  • Linagliptin and Metformin — DRUG
    The control group will be treated with 5mg Linagliptin and Metformin.

Study Details

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.

Key Dates

Start date
Jun 30, 2024
Status verified
Feb 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: intervention
    Patients whose blood glucose are regulated by10 mg of Henagliflozein and metformin.
  • Placebo Comparator: placebo
    Patients whose blood glucose are regulated by5mg of Linagliptin and metformin.

Primary Outcome Measure

The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group. [ Time Frame: 24 weeks ]

Central Contacts

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