A Multicenter, Randomized, Open-Label Study to Compare the Effects of Gemigliptin Add-on or Escalation of Metformin Dose on Glycemic Control and Safety in Patients with Inadequately Controlled Type 2 Diabetes Mellitus Treated with Metformin and SGLT-2 Inhibitors (SO GOOD Study)
Table 1
Baseline characteristics of the included participants.
Metformin ()
Gemigliptin ()
value
Age (y)
0.220
Male, (%)
20 (58.82)
21 (63.64)
0.686
DM duration (y)
0.229
Weight (kg)
0.762
BMI (kg/m2)
0.760
Waist circumference (cm)
0.786
Hypertension, (%)
23 (67.65)
18 (54.55)
0.271
Cardiovascular disease, (%)
4 (11.76)
6 (18.18)
0.461
Dyslipidemia, (%)
28 (82.35)
24 (72.73)
0.345
Systolic blood pressure (mmHg)
0.613
Diastolic blood pressure (mmHg)
0.839
HbA1c (%)
0.095
Fasting plasma glucose (mg/dL)
0.441
Postprandial glucose (mg/dL)
0.879
Fasting insulin (mIU/L)
0.191
HOMA-IR
0.306
HOMA-β
0.066
Total cholesterol (mg/dL)
0.665
Triglyceride (mg/dL)
0.693
HDL-C (mg/dL)
0.527
LDL-C (mg/dL)
0.879
eGFR (mL/min/1.73 m2)
0.501
AST (U/L)
0.352
ALT (U/L)
0.849
UACR
17.8 (34.9)
511.7 (13.7)
0.171
Acetoacetate (μmol/L)
102.1 (138.2)
121.7 (183.6)
0.367
Total ketone (μmol/L)
287.3 (254.8)
315.2 (365.7)
0.407
β-Hydroxybutyric acid (μmol/L)
143.2 (171.2)
197.1 (203.3)
0.533
Antidiabetic medication prior to randomization
SGLT2 inhibitor
Dapagliflozin, (%)
15 (44.12)
17 (51.52)
0.801
Empagliflozin, (%)
15 (44.12)
12 (36.36)
Ipragliflozin, (%)
4 (11.76)
4 (12.12)
Metformin dosage (mg/day)
0.684
Concomitant medications
Antihypertensive drugs, (%)
20 (58.82)
16 (48.48)
0.396
Antidyslipidemic drugs, (%)
30 (88.24)
26 (78.79)
0.297
Antiplatelet drugs, (%)
9 (26.47)
5 (15.15)
0.255
Values are presented as , median (interquartile range), or number (%). BMI: body mass index; HOMA-IR: homeostasis model assessment of insulin resistance; HOMA-β: homeostasis model assessment of β-cell function; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; AST: aspartate aminotransferase; ALT: alanine aminotransferase; UACR: urine albumin-to-creatinine ratio.
