The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Enavogliflozin 0.3mg once daily
Pioglitazone 15mg once daily
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGChanges of HbA1c from the baseline
Time frame: 24 weeks
Patients achieving HbA1c levels below 7%
N and percentage of the patients
Time frame: 24 weeks
Changes of body fat (whole body fat, abdominal fat)
kg, %; measured with bioelectrical impedance analysis
Time frame: 24 weeks
Changes of body weight
Time frame: 12 weeks, 24 weeks
Changes of glucose levels (fasting, 2-hour postprandial)
mg/dL
Time frame: 12 weeks, 24 weeks
Changes of systolic/diastolic blood pressures
mmHg
Time frame: 12 weeks, 24 weeks
Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)
mg/dL
Time frame: 12 weeks, 24 weeks
Changes of electrolytes (uric acid)
mg/dL
Time frame: 12 weeks, 24 weeks
Changes in parathyroid hormone
pg/mL
Time frame: 12 weeks, 24 weeks
Changes in 25-hydroxyl vitamin D3
ng/mL
Time frame: 12 weeks, 24 weeks
Changes of albuminuria
mg/g
Time frame: 12 weeks, 24 weeks
Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)
mg/dL
Time frame: 12 weeks, 24 weeks
Changes in ketone body
umol/L
Time frame: 12 weeks, 24 weeks
Changes of carotid intima-media thickness
maximal thickness (mm)
Time frame: 24 weeks
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