Table 1.
Baseline demographic and clinical characteristics of Asian patients
| Characteristic | Linagliptin (n = 465) | Glimepiride (n = 468) |
|---|---|---|
| Age, years | 61.4 ± 9.4 | 61.3 ± 9.4 |
| Sex, n (%) | ||
| Male | 311 (66.9) | 304 (65.0) |
| Female | 154 (33.1) | 164 (35.0) |
| Race, n (%) | ||
| Asian | 464 (99.8) | 468 (100.0) |
| White | 1 (0.2) | 0 |
| Smoking status, n (%) | ||
| Never smoker | 239 (51.4) | 269 (57.5) |
| Ex-smoker | 127 (27.3) | 127 (27.1) |
| Current smoker | 99 (21.3) | 72 (15.4) |
| CV risk entry criteria | ||
| Previous vascular disease | 199 (42.8) | 202 (43.2) |
| Microvascular complications | 58 (12.5) | 76 (16.2) |
| Age ≥ 70 years | 113 (24.3) | 112 (23.9) |
| ≥ 2 CV risk factors | 366 (78.7) | 349 (74.6) |
| None of above or missing data | 0 | 1 (0.2) |
| Heart failure, n (%) | 7 (1.5) | 20 (4.3) |
| Atherosclerotic CV disease, n (%) | 213 (45.8) | 213 (45.5) |
| Coronary artery disease | 155 (33.3) | 159 (34.0) |
| Cerebrovascular disease | 61 (13.1) | 69 (14.7) |
| Peripheral artery disease | 19 (4.1) | 18 (3.8) |
| Hypertension, n (%) | 413 (88.8) | 417 (89.1) |
| Microvascular disease, n (%) | 137 (29.5) | 154 (32.9) |
| Diabetic neuropathy | 51 (11.0) | 55 (11.8) |
| Diabetic nephropathy | 82 (17.6) | 86 (18.4) |
| Diabetic retinopathy | 39 (8.4) | 48 (10.3) |
| eGFR (MDRD), ml/min/1.73 m2 | 77.8 ± 20.9 | 77.1 ± 20.4 |
| eGFR (MDRD), n (%) | ||
| ≥ 90 ml/min/1.73 m2 | 127 (27.3) | 125 (26.7) |
| ≥ 60– < 90 ml/min/1.73 m2 | 242 (52.0) | 245 (52.4) |
| ≥ 30 − < 60 ml/min/1.73 m2 | 94 (20.2) | 95 (20.3) |
| ≥ 15 − < 30 ml/min/1.73 m2 | 1 (0.2) | 3 (0.6) |
| < 15 ml/min/1.73 m2 | 1 (0.2) | 0 |
| UACR, mg/g, median (25th–75th percentile) | 13.3 (7.1–33.6) | 13.3 (6.2–38.5) |
| UACR, n (%) | ||
| < 30 mg/g | 339 (72.9) | 328 (70.1) |
| 30–300 mg/g | 106 (22.8) | 111 (23.7) |
| > 300 mg/g | 20 (4.3) | 29 (6.2) |
| BMI, kg/m2a | 26.5 ± 3.7a | 26.3 ± 3.8 |
| HbA1c, % | 7.1 ± 0.5 | 7.1 ± 0.5 |
| Fasting plasma glucose, mg/dl | 129 ± 26 | 130 ± 24 |
| Diabetes duration, years, median (25th–75th percentile) | 5.2 (2.4–9.8) | 5.0 (2.3–9.1) |
| Diabetes duration ≤ 5 years, n (%) | 226 (48.6) | 233 (49.8) |
| Systolic blood pressure, mmHg | 133 ± 15 | 132 ± 16 |
| Diastolic blood pressure, mmHg | 79 ± 9 | 79 ± 10.0 |
| Pulse rate, beats per minute | 72 ± 11 | 72 ± 11 |
| Total cholesterol, mg/dlb | 164 ± 36 | 166 ± 41 |
| LDL cholesterol, mg/dlc | 85 ± 30 | 87 ± 37 |
| HDL cholesterol, mg/dlb | 50 ± 13 | 50 ± 13 |
| Triglycerides, mg/dlb | 150 ± 101 | 155 ± 149 |
| Glucose-lowering therapy, n (%) | ||
| Metformin | 360 (77.4) | 362 (77.4) |
| SU | 183 (39.4) | 171 (36.5) |
| Alpha-glucosidase inhibitor | 39 (8.4) | 34 (7.3) |
| Glinide (meglitinide) | 9 (1.9) | 8 (1.7) |
| Number of background glucose-lowering therapies, n (%) | ||
| 0 | 35 (7.5) | 46 (9.8) |
| 1 | 273 (58.7) | 269 (57.5) |
| 2 | 153 (32.9) | 152 (32.5) |
| 3 | 4 (0.9) | 1 (0.2) |
| Antihypertensives, n (%) | 424 (91.2) | 422 (90.2) |
| Angiotensin receptor blockers | 218 (46.9) | 216 (46.2) |
| Calcium antagonists | 194 (41.7) | 202 (43.2) |
| β-blockers | 180 (38.7) | 174 (37.2) |
| ACE inhibitors | 108 (23.2) | 118 (25.2) |
| Diuretics | 97 (20.9) | 104 (22.2) |
| Acetylsalicylic acid (aspirin), n (%) | 230 (49.5) | 217 (46.4) |
| Statins, n (%) | 325 (69.9) | 333 (71.2) |
Data are mean ± SD for patients treated with ≥ 1 dose of study medication unless otherwise specified
ACE angiotensin-converting enzyme, BMI body mass index, CV cardiovascular, eGFR estimated glomerular filtration rate, HbA1c glycated hemoglobin, HDL high-density lipoprotein, LDL low-density lipoprotein, MDRD Modification of Diet in Renal Disease, SD standard deviation, SE standard error, SU sulfonylurea, UACR urinary albumin-to-creatinine ratio
aData missing for 1 patient on linagliptin
bData missing for 17 patients (linagliptin: n = 7; glimepiride: n = 10)
cData missing for 39 patients (linagliptin: n = 19; glimepiride: n = 20)