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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Fibrosis; Obesity; Type 2 Diabetes; Magnetic Resonance Imaging; Sodium-glucose Co-transporter-2 Inhibitor
• Intervention / Treatment: Drug: Henagliflozin; Drug: Metformin

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rong Huang; Phone Number: 68-021-68383424; Email: renjihuangrong@163.com
• Study Contact Backup: Name: YiCheng Qi; Phone Number: 68-021-68383420; Email: qiyicheng@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Henagliflozin; Henagliflozin 10mg qd po	Drug: Henagliflozin; Henagliflozin 10mg qd po; Other Names: SHR3824
Active Comparator: Metformin; Metformin 1000mg bid po	Drug: Metformin; Metformin 1000mg bid po; Other Names: Metformin Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extra-cellular volume fraction	To compare the effects of henagliflozin and metformin on extra-cellular volume fraction	baseline and week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jing Ma, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Metformin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus, Type 2; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: IIT-2023-0180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No