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

NCT ID: NCT06059287

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Henagliflozin

Henagliflozin 10mg qd po

Group Type: EXPERIMENTAL

Henagliflozin

Intervention Type: DRUG

Henagliflozin 10mg qd po

Metformin

Metformin 1000mg bid po

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin 1000mg bid po

Interventions

Henagliflozin

Henagliflozin 10mg qd po

Intervention Type: DRUG

Metformin

Metformin 1000mg bid po

Intervention Type: DRUG

Other Intervention Names

SHR3824; Metformin Hydrochloride

Eligibility Criteria

Inclusion Criteria

• Individuals with type 2 diabetes newly diagnosed based on the WHO (1999) criteria;
• Hemoglobin A1c levels >=7.0% and <=8.0%;
• Females or males ≥18 years up to 75 years of age.

Exclusion Criteria

• Females or males <18 years.
• Clinical diagnosis of type 1 diabetes and other types of diabetes.
• Blood pressure at screening that would require a change in blood pressure treatment over the study period.
• History of stroke or other clinically significant cerebrovascular disease.
• Any of the following cardiovascular diseases:

1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function

2. Unstable heart failure or any heart failure with NYHA class III and IV

3. Significant valvular disease

4. Significant peripheral artery disease

• Active malignancy requiring treatment at the time of visit 0.
• Patients with severe hepatic impairment.
• Unstable or rapidly progressing renal disease.
• Ongoing treatment with loop diuretics.
• Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.
• Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing Ma

Executive Officer of Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Ma

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Central Contacts

Rong Huang

Role: CONTACT

renjihuangrong@163.com

68-021-68383424

YiCheng Qi

Role: CONTACT

qiyicheng@renji.com

68-021-68383420

Other Identifiers

IIT-2023-0180

Identifier Type: -

Identifier Source: org_study_id