| Trial ID: | L6981 |
| Source ID: | NCT06846411
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
The EMPA-FIT Study
|
| Acronym: |
EMPA-FIT
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type II
|
| Interventions: |
DRUG: Empagliflozin 10 mg|DRUG: Metformin
|
| Outcome Measures: |
Primary: 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 | Secondary: 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), 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
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
46
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-01-01
|
| Completion Date: |
2025-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-26
|
| Locations: |
SNUBH, Seongnam, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06846411
|
