Clinical trial NCT06059287: The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Sodium-glucose Co-transporter-2 Inhibitor
Myocardial Fibrosis
Magnetic Resonance Imaging
Keywords: Metformin
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Extra-cellular volume fraction
timeFrame: baseline and week 24
Secondary outcomes:
measure: Mean Change in HbA1c Levels
timeFrame: baseline and week 24
measure: Mean change in body mass index
timeFrame: baseline and week 24
measure: Mean change in blood pressure
timeFrame: baseline and week 24
measure: Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: baseline and week 24
measure: Native T2 mapping
timeFrame: baseline and week 24
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Jing Ma
role: PRINCIPAL_INVESTIGATOR
References: