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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Henagliflozin | Experimental | Henagliflozin 10mg qd po |
|
| Metformin | Active Comparator | Metformin 1000mg bid po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henagliflozin | Drug | Henagliflozin 10mg qd po |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Extra-cellular volume fraction | To compare the effects of henagliflozin and metformin on extra-cellular volume fraction | baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in HbA1c Levels | To compare the effects of henagliflozin and metformin on HbA1c Levels | baseline and week 24 |
| Mean change in body mass index | To compare the effects of henagliflozin and metformin on body mass index |
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Inclusion 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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Huang | Contact | 68-021-68383424 | renjihuangrong@163.com | |
| YiCheng Qi | Contact | 68-021-68383420 | qiyicheng@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Ma | RenJi Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | Metformin 1000mg bid po |
|
|
| baseline and week 24 |
| Mean change in blood pressure | To compare the effects of henagliflozin and metformin on blood pressure | 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 | baseline and week 24 |
| Native T2 mapping | To compare the effects of henagliflozin and metformin on native T2 mapping | baseline and week 24 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |