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 2
Study outcomes according to treatment group.
Metformin ()
Gemigliptin ()
value
HbA1c (%)
Baseline
0.095
At week 12
0.003
At week 24
0.017
Change from baseline at week 12
0.009
Change from baseline at week 24
0.045
Fasting plasma glucose (mg/dL)
Baseline
0.441
At week 12
0.813
At week 24
0.293
Change from baseline at week 12
0.657
Change from baseline at week 24
0.087
Postprandial glucose (mg/dL)
Baseline
0.879
At week 12
0.368
At week 24
0.822
Change from baseline at week 12
0.345
Change from baseline at week 24
0.680
Fasting insulin (mIU/L)
Baseline
0.191
At week 24
0.781
Change from baseline at week 24
0.075
HOMA-IR
Baseline
0.306
At week 24
0.957
Change from baseline at week 24
0.238
HOMA-β
Baseline
0.066
At week 24
0.649
Change from baseline at week 24
0.011
Total cholesterol (mg/dL)
Baseline
0.665
At week 24
0.642
Change from baseline at week 24
-
0.996
Triglyceride (mg/dL)
Baseline
0.693
At week 24
0.628
Change from baseline at week 24
0.234
HDL-C (mg/dL)
Baseline
0.527
At week 24
0.534
Change from baseline at week 24
0.969
LDL-C (mg/dL)
Baseline
0.879
At week 24
0.462
Change from baseline at week 24
0.424
UACR
Baseline
17.8 (34.9)
11.7 (13.7)
0.171
At week 24
19.4 (48.3)
12.8 (10.0)
0.107
Change from baseline at week 24
0.4 (15.7)
-0.3 (12.7)
0.541
Acetoacetate (μmol/L)
Baseline
102.1 (138.2)
121.7 (183.6)
0.367
At week 24
86.2 (120.2)
90 (152.0)
0.779
Change from baseline at week 24
-18.4 (159.8)
-2.4 (244.6)
0.817
Total ketone (μmol/L)
Baseline
287.3 (254.8)
315.2 (365.7)
0.407
At week 24
231.4 (212.1)
205.2 (282.2)
0.827
Change from baseline at week 24
-38.0 (310.6)
-20.0 (485.7)
0.640
β-Hydroxybutyric acid (μmol/L)
Baseline
143.2 (171.2)
197.1 (203.3)
0.533
At week 24
121.9 (114.6)
114.6 (109.8)
0.856
Change from baseline at week 24
-37.0 (166.4)
-24.4 (242.8)
0.764
Values are presented as or median (interquartile range). values were applied by independent -test or the Wilcoxon rank-sum test. 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; UACR: urine albumin-to-creatinine ratio.
