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

Primary Purpose

Obesity, Type 2 Diabetes, Sodium-glucose Co-transporter-2 Inhibitor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Henagliflozin
Metformin
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Metformin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Henagliflozin

    Metformin

    Arm Description

    Henagliflozin 10mg qd po

    Metformin 1000mg bid po

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Mean Change in HbA1c Levels
    To compare the effects of henagliflozin and metformin on HbA1c Levels
    Mean change in body mass index
    To compare the effects of henagliflozin and metformin on body mass index
    Mean change in blood pressure
    To compare the effects of henagliflozin and metformin on blood pressure
    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
    Native T2 mapping
    To compare the effects of henagliflozin and metformin on native T2 mapping

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 27, 2023
    Sponsor
    RenJi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06059287
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    RenJi Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Type 2 Diabetes, Sodium-glucose Co-transporter-2 Inhibitor, Myocardial Fibrosis, Magnetic Resonance Imaging
    Keywords
    Metformin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Henagliflozin
    Arm Type
    Experimental
    Arm Description
    Henagliflozin 10mg qd po
    Arm Title
    Metformin
    Arm Type
    Active Comparator
    Arm Description
    Metformin 1000mg bid po
    Intervention Type
    Drug
    Intervention Name(s)
    Henagliflozin
    Other Intervention Name(s)
    SHR3824
    Intervention Description
    Henagliflozin 10mg qd po
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Metformin Hydrochloride
    Intervention Description
    Metformin 1000mg bid po
    Primary Outcome Measure Information:
    Title
    Extra-cellular volume fraction
    Description
    To compare the effects of henagliflozin and metformin on extra-cellular volume fraction
    Time Frame
    baseline and week 24
    Secondary Outcome Measure Information:
    Title
    Mean Change in HbA1c Levels
    Description
    To compare the effects of henagliflozin and metformin on HbA1c Levels
    Time Frame
    baseline and week 24
    Title
    Mean change in body mass index
    Description
    To compare the effects of henagliflozin and metformin on body mass index
    Time Frame
    baseline and week 24
    Title
    Mean change in blood pressure
    Description
    To compare the effects of henagliflozin and metformin on blood pressure
    Time Frame
    baseline and week 24
    Title
    Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
    Description
    To compare the effects of henagliflozin and metformin on level of Homeostatic Model Assessment of Insulin Resistance
    Time Frame
    baseline and week 24
    Title
    Native T2 mapping
    Description
    To compare the effects of henagliflozin and metformin on native T2 mapping
    Time Frame
    baseline and week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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: 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 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rong Huang
    Phone
    68-021-68383424
    Email
    renjihuangrong@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    YiCheng Qi
    Phone
    68-021-68383420
    Email
    qiyicheng@renji.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jing Ma
    Organizational Affiliation
    RenJi Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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