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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin and Metformin Group | Experimental | Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. |
|
| Metformin and Placebo Group | Active Comparator | Participants in this group will receive Metformin and Placebo for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Epicardial Fat Thickness | Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks | At Baseline, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Mass (LVM) | LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24 | At Baseline, Week 12 and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Iacobellis, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin and Metformin Group | Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL |
| FG001 | Metformin and Placebo Group | Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin and Metformin Group | Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Epicardial Fat Thickness | Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks | Data is reported only for the participants that completed the study intervention. | Posted | Mean | Standard Deviation | mm | At Baseline, 12 weeks, 24 weeks |
|
24 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapagliflozin and Metformin Group | Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianluca Iacobellis, MD | University of Miami | 305-243-3636 | giacobellis@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2014 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL |
|
| Placebo | Drug | Placebo pill taken once daily to mimic Dapagliflozin |
|
| Withdrawal by Subject |
|
| BG001 | Metformin and Placebo Group | Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Metformin and Placebo Group |
Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin |
|
|
| Secondary | Left Ventricular Mass (LVM) | LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24 | Due to time and technical limitations, LVM data were not collected for all participants that completed the study intervention. | Posted | Mean | Standard Deviation | g/m^2 | At Baseline, Week 12 and Week 24 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 8 |
| 50 |
| EG001 | Metformin and Placebo Group | Participants in this group will receive Metformin and Placebo for 6 months. Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL Placebo: Placebo pill taken once daily to mimic Dapagliflozin | 0 | 50 | 0 | 50 | 2 | 50 |
| Balanitis | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Distention | Gastrointestinal disorders | Systematic Assessment |
|
| Frequency of Urination | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
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| Week 24 |
|