NCT06059287

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

September 21, 2023

Last Update Submit

September 27, 2023

Conditions

ObesityType 2 DiabetesSodium-glucose Co-transporter-2 InhibitorMyocardial FibrosisMagnetic Resonance Imaging

Keywords

Metformin

Outcome Measures

Primary Outcomes (1)

  • Extra-cellular volume fraction

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

    baseline and week 24

Secondary Outcomes (5)

  • 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

Study Arms (2)

Henagliflozin

EXPERIMENTAL

Henagliflozin 10mg qd po

Drug: Henagliflozin

Metformin

ACTIVE COMPARATOR

Metformin 1000mg bid po

Drug: Metformin

Interventions

HenagliflozinDRUG

Henagliflozin 10mg qd po

Also known as: SHR3824
Henagliflozin
MetforminDRUG

Metformin 1000mg bid po

Also known as: Metformin Hydrochloride
Metformin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

henagliflozinMetformin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jing Ma

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Huang

CONTACT

68-021-68383424renjihuangrong@163.com

YiCheng Qi

CONTACT

68-021-68383420qiyicheng@renji.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Officer of Endocrinology Department

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

October 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share