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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059287
• Other study ID #: IIT-2023-0180
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: RenJi Hospital
• Contact: Rong Huang
• Phone: 68-021-68383424
• Email: renjihuangrong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Magnetic Resonance Imaging
• Myocardial Fibrosis
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Henagliflozin
Henagliflozin 10mg qd po
• Metformin
Metformin 1000mg bid po

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extra-cellular volume fraction	To compare the effects of henagliflozin and metformin on extra-cellular volume fraction	baseline and week 24
Secondary	Mean Change in HbA1c Levels	To compare the effects of henagliflozin and metformin on HbA1c Levels	baseline and week 24
Secondary	Mean change in body mass index	To compare the effects of henagliflozin and metformin on body mass index	baseline and week 24
Secondary	Mean change in blood pressure	To compare the effects of henagliflozin and metformin on blood pressure	baseline and week 24
Secondary	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
Secondary	Native T2 mapping	To compare the effects of henagliflozin and metformin on native T2 mapping	baseline and week 24