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Clinical Trials/NCT06059287
NCT06059287Not yet recruitingNot Applicable

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

RenJi Hospital0 sites64 target enrollmentStarted: October 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
64
Primary Endpoint
Extra-cellular volume fraction

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
  • Unstable heart failure or any heart failure with NYHA class III and IV
  • Significant valvular disease
  • Significant peripheral artery disease
  • Active malignancy requiring treatment at the time of visit
  • 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 m
  • Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.

Arms & Interventions

Henagliflozin

Experimental

Henagliflozin 10mg qd po

Intervention: Henagliflozin (Drug)

Metformin

Active Comparator

Metformin 1000mg bid po

Intervention: Metformin (Drug)

Outcomes

Primary Outcomes

Extra-cellular volume fraction

Time Frame: baseline and week 24

To compare the effects of henagliflozin and metformin on extra-cellular volume fraction

Secondary Outcomes

  • Mean Change in HbA1c Levels(baseline and week 24)
  • Mean change in body mass index(baseline and week 24)
  • Mean change in blood pressure(baseline and week 24)
  • Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(baseline and week 24)
  • Native T2 mapping(baseline and week 24)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jing Ma

Executive Officer of Endocrinology Department

RenJi Hospital

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