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

Not Applicable

Not yet recruiting

• Conditions: Sodium-glucose Co-transporter-2 Inhibitor; Magnetic Resonance Imaging; Obesity; Type 2 Diabetes; Myocardial Fibrosis
• Interventions: Drug: Metformin; Drug: Henagliflozin

• Registration Number: NCT06059287
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Study Start: 2023-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Metformin 1000mg bid po
Henagliflozin	Henagliflozin	Henagliflozin 10mg qd po

Primary Outcome Measures

Name	Time	Method
Extra-cellular volume fraction	baseline and week 24	To compare the effects of henagliflozin and metformin on extra-cellular volume fraction

Secondary Outcome Measures

Name	Time	Method
Mean change in body mass index	baseline and week 24	To compare the effects of henagliflozin and metformin on body mass index
Mean Change in HbA1c Levels	baseline and week 24	To compare the effects of henagliflozin and metformin on HbA1c Levels
Mean change in blood pressure	baseline and week 24	To compare the effects of henagliflozin and metformin on blood pressure
Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	baseline and week 24	To compare the effects of henagliflozin and metformin on level of Homeostatic Model Assessment of Insulin Resistance
Native T2 mapping	baseline and week 24	To compare the effects of henagliflozin and metformin on native T2 mapping