Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06449833
PHASE4

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

Sponsor: Zhujiang Hospital

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.

Official title: Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-06

Completion Date

2026-11

Last Updated

2024-06-10

Healthy Volunteers

No

Interventions

DRUG

Henagliflozein and Metformin

The experimental group will be treated with 10mg Henagliflozein and Metformin.

DRUG

Linagliptin and Metformin

The control group will be treated with 5mg Linagliptin and Metformin.

Locations (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China