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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
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.
SNUBH
Seongnam, South Korea
RECRUITINGmean 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
Time frame: 24 weeks
SD of glucose
Standard deviation of glucose obtained from continuous glucose monitoring (CGM)
Time frame: 24 weeks
Time in range (TIR)
Time in range obtained from continuous glucose monitoring (CGM)
Time frame: 24 weeks
Mean Blood Glucose (MBG)
Mean Blood Glucose (MBG) obtained from continuous glucose monitoring (CGM)
Time frame: 24 weeks
Glucose Management Indicator (GMI)
Glucose Management Indicator (GMI) obtained from continuous glucose monitoring (CGM)
Time frame: 24 weeks
Coefficient of Variation (CV)
Coefficient of Variation (CV) obtained from continuous glucose monitoring (CGM)
Time frame: 24 weeks
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