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

NCT06059287 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Henagliflozin

Henagliflozin 10mg qd po

DRUG

Metformin

Metformin 1000mg bid po

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jing Ma · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059287 on ClinicalTrials.gov