ObesityNCT06059287
The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics
A study testing Henagliflozin and Metformin in people with Obesity and Type 2 Diabetes, run by RenJi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Type 2 Diabetes, Sodium-glucose Co-transporter-2 Inhibitor
- What is being tested?
- Henagliflozin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Obesity, Type 2 Diabetes, Sodium-glucose Co-transporter-2 Inhibitor, Myocardial Fibrosis, Magnetic Resonance Imaging
- Being tested
- Henagliflozin, Metformin
- Keywords
- Metformin
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HenagliflozinDrug
Also called SHR3824
Henagliflozin 10mg qd po
MetforminDrug
Also called Metformin Hydrochloride
Metformin 1000mg bid po
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin | Experimental | Henagliflozin 10mg qd po Receives: Drug: Henagliflozin |
| Metformin | Active comparator | Metformin 1000mg bid po Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extra-cellular volume fraction
To compare the effects of henagliflozin and metformin on extra-cellular volume fraction
Measured: baseline and week 24
Secondary outcomes (5)
Mean Change in HbA1c Levels
To compare the effects of henagliflozin and metformin on HbA1c Levels
Measured: baseline and week 24
Mean change in body mass index
To compare the effects of henagliflozin and metformin on body mass index
Measured: baseline and week 24
Mean change in blood pressure
To compare the effects of henagliflozin and metformin on blood pressure
Measured: baseline and week 24
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
Measured: baseline and week 24
Native T2 mapping
To compare the effects of henagliflozin and metformin on native T2 mapping
Measured: baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Ma, RenJi Hospital
- Investigators
- Jing Ma, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059287
- Sponsor's protocol ID
- IIT-2023-0180
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06059287
- Acronym / sponsor ID
- IIT-2023-0180
- Conditions
- Obesity, Type 2 Diabetes, Sodium-glucose Co-transporter-2 Inhibitor, Myocardial Fibrosis, Magnetic Resonance Imaging
- Keywords
- Metformin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin | Experimental | Drug: HenagliflozinHenagliflozin 10mg qd po |
| Metformin | Active comparator | Drug: MetforminMetformin 1000mg bid po |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HenagliflozinAlso: SHR3824Henagliflozin 10mg qd po | Drug | Henagliflozin |
| MetforminAlso: Metformin HydrochlorideMetformin 1000mg bid po | Drug | Metformin |
Primary outcome
Extra-cellular volume fraction
Time frame: baseline and week 24
To compare the effects of henagliflozin and metformin on extra-cellular volume fraction
5 secondary outcomes
Mean Change in HbA1c Levels
Time frame: baseline and week 24
Mean change in body mass index
Time frame: baseline and week 24
Mean change in blood pressure
Time frame: baseline and week 24
Mean change in level of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: baseline and week 24
Native T2 mapping
Time frame: baseline and week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Ma principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Henagliflozin and Metformin in people with Obesity and Type 2 Diabetes, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Huang (68-021-68383424, renjihuangrong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extra-cellular volume fraction (time frame: baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.