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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-02251 | Other Grant/Funding Number | BI |
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This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Metformin therapy |
|
| Experimental | Experimental | Empagliflozin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 mg | Drug | The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin. |
| Measure | Description | Time Frame |
|---|---|---|
| mean amplitude of glucose excursion (MAGE) | MAGE is a key glucose variability index that assesses the amplitude of clinically relevant glucose fluctuations and is calculated as the mean of the differences between consecutive glucose nadirs and peaks that exceed one standard deviation (SD) above or below the mean glucose level | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SD of glucose | Standard deviation of glucose obtained from continuous glucose monitoring (CGM) | 24 weeks |
| Time in range (TIR) | Time in range obtained from continuous glucose monitoring (CGM) |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides >1,000 mg/dL or LDL cholesterol >250 mg/dL).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Young Byun Administrative staff, MS | Contact | 82-31-787-7035 | 65423@snubh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNUBH | Recruiting | Seongnam | South Korea |
Anthropometric and biochemical data.
1 year.
Soo Lim
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin. |
|
| 24 weeks |
| Mean Blood Glucose (MBG) | Mean Blood Glucose (MBG) obtained from continuous glucose monitoring (CGM) | 24 weeks |
| Glucose Management Indicator (GMI) | Glucose Management Indicator (GMI) obtained from continuous glucose monitoring (CGM) | 24 weeks |
| Coefficient of Variation (CV) | Coefficient of Variation (CV) obtained from continuous glucose monitoring (CGM) | 24 weeks |