Diabetes, Diabetes Mellitus, Type II
Conditions
Keywords
Metformin, empagliflozin, glucose variability
Brief summary
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.
Interventions
DRUGEmpagliflozin 10 mg
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.
DRUGMetformin
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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening.
Exclusion criteria
* individuals with a body mass index (BMI) \<18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR \<60 mL/min/1.73 m²) or end-stage renal disease (eGFR \<15 mL/min/1.73 m² or on dialysis) were also excluded. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean amplitude of glucose excursion (MAGE) | 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SD of glucose | 24 weeks | Standard deviation of glucose obtained from continuous glucose monitoring (CGM) |
| Time in range (TIR) | 24 weeks | Time in range obtained from continuous glucose monitoring (CGM) |
| Mean Blood Glucose (MBG) | 24 weeks | Mean Blood Glucose (MBG) obtained from continuous glucose monitoring (CGM) |
| Glucose Management Indicator (GMI) | 24 weeks | Glucose Management Indicator (GMI) obtained from continuous glucose monitoring (CGM) |
| Coefficient of Variation (CV) | 24 weeks | Coefficient of Variation (CV) obtained from continuous glucose monitoring (CGM) |
Countries
South Korea
Contacts
Primary ContactJi Young Byun Administrative staff, MS
Outcome results
None listed