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

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059287
Collaborator
(none)
64
Enrollment
2
Arms
27
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Henagliflozin

Henagliflozin 10mg qd po

Drug: Henagliflozin
Henagliflozin 10mg qd po
Other Names:
  • SHR3824

    		•
    Active Comparator: Metformin

    Metformin 1000mg bid po

    Drug: Metformin
    Metformin 1000mg bid po
    Other Names:
  • Metformin Hydrochloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Extra-cellular volume fraction [baseline and week 24]

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

    Secondary Outcome Measures

    1. Mean Change in HbA1c Levels [baseline and week 24]

      To compare the effects of henagliflozin and metformin on HbA1c Levels

    2. Mean change in body mass index [baseline and week 24]

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

    3. Mean change in blood pressure [baseline and week 24]

      To compare the effects of henagliflozin and metformin on blood pressure

    4. Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [baseline and week 24]

      To compare the effects of henagliflozin and metformin on level of Homeostatic Model Assessment of Insulin Resistance

    5. Native T2 mapping [baseline and week 24]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    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:

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Principal Investigator: Jing Ma, RenJi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jing Ma, Executive Officer of Endocrinology Department, RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT06059287
    Other Study ID Numbers:
    • IIT-2023-0180
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jing Ma, Executive Officer of Endocrinology Department, RenJi Hospital
    Metformin
    Additional relevant MeSH terms:
    Obesity
    Diabetes Mellitus, Type 2
    Metformin

    Study Results

    No Results Posted as of Sep 28, 2023