Table 1.
Baseline characteristics
| Variable | Safety set (n=2,228) | Efficacy set (n=1,651) |
|---|---|---|
| Sex | ||
| Male | 1,363 (61.18) | 1,025 (62.08) |
| Female | 865 (38.82) | 626 (37.92) |
|
| ||
| Age, yr | 64.07±11.53 | 63.94±11.34 |
|
| ||
| Age groups, yr | ||
| <20 | 1 (0.04) | 1 (0.06) |
| ≥20 to <30 | 11 (0.49) | 7 (0.42) |
| ≥30 to <40 | 33 (1.48) | 18 (1.09) |
| ≥40 to <50 | 186 (8.35) | 148 (8.96) |
| ≥50 to <60 | 524 (23.52) | 392 (23.74) |
| ≥60 to <70 | 738 (33.12) | 555 (33.62) |
| ≥70 to <80 | 531 (23.83) | 382 (23.14) |
| ≥80 to <90 | 192 (8.62) | 140 (8.48) |
| ≥90 | 12 (0.54) | 8 (0.48) |
|
| ||
| Duration of diabetes, yr | 13.01±8.07 | 12.87±7.98 |
|
| ||
| Weight, kg | 67.02±11.78a | 67.70±11.27b |
|
| ||
| BMI, kg/m2 | 25.09±3.50c | 25.25±3.38d |
|
| ||
| BMI groups, kg/m2 | ||
| <18.5 | 20 (1.47) | 11 (1.14) |
| ≥18.5 to <22.0 | 225 (16.56) | 137 (14.15) |
| ≥22.0 to <25.0 | 463 (34.07) | 331 (34.19) |
| ≥25.0 to <30.0 | 534 (39.29) | 406 (41.95) |
| ≥30.0 | 117 (8.61) | 83 (8.57) |
|
| ||
| Prescribed antidiabetic drugs | ||
| No (Naïve) | 264 (11.85) | 264 (15.99) |
| Yes | 1,964 (88.15) | 1,387 (84.01) |
| No. of prescribed antidiabetic drugs | ||
| Single class | 384 (17.24) | 226 (13.69) |
| Double classes | 894 (40.12) | 733 (44.40) |
| Triple classes | 642 (28.82) | 410 (24.83) |
| Quadruple classes | 43 (1.93) | 18 (1.09) |
| Quintuple classes | 1 (0.04) | - |
| Types of prescribed antidiabetic drugs | ||
| DPP-4 inhibitors | 1,379 (61.89) | 1,053 (63.78) |
| GLP-1 receptor agonist | 5 (0.22) | 2 (0.12) |
| Insulin | 228 (10.23) | 128 (7.75) |
| Meglitinides | 18 (0.81) | 10 (0.61) |
| Metformin | 1,557 (69.88) | 1,130 (68.44) |
| Pioglitazone | 92 (4.13) | 16 (0.97) |
| Sulfonylurea | 912 (40.93) | 622 (37.67) |
| SGLT-2 inhibitor | 42 (1.89) | 16 (0.97) |
| α-Glucosidase inhibitor | 42 (1.89) | 17 (1.03) |
|
| ||
| History of diabetes complicationsg | ||
| Diabetic foot | 4 (0.18) [4] | 3 (0.18) [3] |
| Diabetic nephropathy | 68 (3.05) [68] | 44 (2.67) [44] |
| Diabetic neuropathy | 312 (14.00) [313] | 219 (13.26) [220] |
| Diabetic retinopathy | 212 (9.52) [212] | 161 (9.75) [161] |
|
| ||
| Liver functiong | ||
| Aspartate aminotransferase | 24.84±10.00e | 24.67±8.69f |
| Alanine aminotransferase | 24.81±14.31e | 26.58±15.19f |
|
| ||
| History of hepatobiliary disordersg,h | 157 (7.05) [172] | 125 (7.57) [133] |
|
| ||
| History of renal failure and impairmentg | 157 (7.05) [160] | 118 (7.15) [120] |
| Acute kidney injury | 5 (0.22) [5] | 4 (0.24) [4] |
| Chronic kidney disease | 146 (6.55) [147] | 109 (6.60) [109] |
| End stage renal disease | 2 (0.09) [2] | 2 (0.12) [2] |
| Renal failure | 4 (0.18) [4] | 4 (0.24) [4] |
| Renal injury | 1 (0.04) [1] | 1 (0.06) [1] |
Values are presented as mean±standard deviation or number (%) [number of events].
BMI, body mass index; DPP-4, dipeptidyl peptidase-4; GLP-1, glucagon-like peptide-1; SGLT-2, sodium glucose cotransporter-2.
n=1,361,
n=970,
n=1,359,
n=968,
n=94,
n=64,
By system organ class (MedDRA version 21.1 preferred term),
Definition of hepatobiliary disorders: alcoholic liver disease, autoimmune hepatitis, bile duct stenosis, bile duct stone, biliary colic, cholangitis, cholecystitis, cholecystitis acute, cholecystitis chronic, cholelithiasis, chronic hepatitis, cirrhosis alcoholic, fatty liver alcoholic, gallbladder polyp, hepatic cirrhosis, hepatic function abnormal, hepatic steatosis, hepatitis, hepatitis alcoholic, hepatorenal syndrome, hepatotoxicity, jaundice, liver disorder, non-alcoholic fatty liver, non-alcoholic steatohepatitis, primary biliary cholangitis, steatohepatitis.