NCT06059287

The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics

The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics in Patients With Type 2 Diabetes and Obesity: A Prospective, Randomized, Open-label, Active Drug Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open-label, active drug controlled clinical trial that aims to compare the effects of henagliflozin or metformin on myocardial tissue level characteristics in type 2 diabetes patients with obesity. Eligible subjects with type 2 diabetes before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to henagliflozin 10 mg once a day or metformin 1000 mg twice a day and treated for 24 weeks. The study includes five visits.

Detailed description

MRI scanning will be assessed at baseline and at the end of the treatment period in order to to assess the cardiac morphology, cardiac function, and myocardial tissue characteristics. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.

Conditions

• Obesity
• Type 2 Diabetes
• Sodium-glucose Co-transporter-2 Inhibitor
• Myocardial Fibrosis
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	Henagliflozin	Henagliflozin 10mg qd po
DRUG	Metformin	Metformin 1000mg bid po

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-09-28
• Last updated: 2023-09-28