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Not yet recruitingNCT06059287Updated Sep 28, 2023

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

An interventional study of Henagliflozin and Metformin in Obesity, Type 2 Diabetes and Sodium-glucose Co-transporter-2 Inhibitor, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Type 2 Diabetes
  • Sodium-glucose Co-transporter-2 Inhibitor
  • Myocardial Fibrosis
  • Magnetic Resonance Imaging

Keywords

  • Metformin
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 64 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Henagliflozin

    Henagliflozin 10mg qd po

    Drug: Henagliflozin

  • Active comparator
    Metformin

    Metformin 1000mg bid po

    Drug: Metformin

Interventions

  • DrugHenagliflozin

    Henagliflozin 10mg qd po

    Also known as: SHR3824

  • DrugMetformin

    Metformin 1000mg bid po

    Also known as: Metformin Hydrochloride

06

What researchers measure

Primary outcomes

  1. Extra-cellular volume fraction

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

    Time frame: baseline and week 24

Secondary outcomes

  1. Mean Change in HbA1c Levels

    To compare the effects of henagliflozin and metformin on HbA1c Levels

    Time frame: baseline and week 24

  2. Mean change in body mass index

    To compare the effects of henagliflozin and metformin on body mass index

    Time frame: baseline and week 24

  3. Mean change in blood pressure

    To compare the effects of henagliflozin and metformin on blood pressure

    Time frame: baseline and week 24

  4. 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

    Time frame: baseline and week 24

  5. Native T2 mapping

    To compare the effects of henagliflozin and metformin on native T2 mapping

    Time frame: baseline and week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06059287
Lead sponsor
RenJi Hospital
Responsible party
Jing Ma (Executive Officer of Endocrinology Department, RenJi Hospital) — Principal investigator
First posted
Sep 28, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 28, 2023

Study contacts

Rong Huang
Contact
renjihuangrong@163.com
68-021-68383424
YiCheng Qi
Contact
qiyicheng@renji.com
68-021-68383420
Jing Ma
principal investigator · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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