Table 1.
Characteristic | Linagliptin (n = 272) | Placebo (n = 283) |
---|---|---|
Age, years | 65.1 ± 9.22 | 65.5 ± 9.40 |
Sex, n (%) | ||
Male | 201 (73.9) | 199 (70.3) |
Female | 71 (26.1) | 84 (29.7) |
Race, n (%) | ||
Asian | 272 (100.0) | 283 (100.0) |
Smoking status, n (%) | ||
Never smoker | 139 (51.1) | 138 (48.8) |
Ex-smoker | 97 (35.7) | 97 (34.3) |
Current smoker | 36 (13.2) | 48 (17.0) |
History of heart failure, n (%) | 34 (12.5) | 21 (7.4) |
Ischemic heart disease, n (%) | 160 (58.8) | 158 (55.8) |
History of hypertension, n (%) | 249 (91.5) | 261 (92.2) |
Atrial fibrillation, n (%) | 21 (7.7) | 19 (6.7) |
eGFR (MDRD), ml/min/1.73 m2 | 52.6 ± 23.9 | 50.9 ± 23.4 |
eGFR (MDRD), n (%) | ||
≥ 90 ml/min/1.73 m2 | 19 (7.0) | 22 (7.8) |
≥ 60– < 90 ml/min/1.73 m2 | 76 (27.9) | 70 (24.7) |
≥ 45 − <60 ml/min/1.73 m2 | 52 (19.1) | 50 (17.7) |
≥ 30 − <45 ml/min/1.73 m2 | 83 (30.5) | 85 (30.0) |
< 30 ml/min/1.73 m2 | 42 (15.4) | 56 (19.8) |
UACR, mg/g, median (25th − 75th percentile) | 299 (95–1420) | 256 (60–1120) |
UACR, n (%) | ||
< 30 mg/g | 19 (7.0) | 39 (13.8) |
30 − 300 mg/g | 118 (43.4) | 110 (38.9) |
> 300 mg/g | 135 (49.6) | 134 (47.3) |
BMI, kg/m2 | 27.2 ± l4.3 | 26.8 ± 4.3 |
HbA1c, % | 7.80 ± 0.98 | 7.81 ± 0.97 |
Fasting plasma glucose, mg/dla | 142.4 ± 46.4 | 140.0 ± 46.5 |
Diabetes duration, years | 14.98 ± 9.63 | 13.70 ± 8.82 |
Systolic blood pressure, mm Hg | 140.5 ± 17.9 | 139.6 ± 18.2 |
Diastolic blood pressure, mm Hg | 76.6 ± 11.6 | 76.2 ± 11.1 |
Heart rate, beats per minuteb | 68.2 ± 12.3 | 67.6 ± 10.7 |
Total cholesterol, mg/dlc | 170.0 ± 49.3 | 169.2 ± 36.7 |
LDL cholesterol, mg/dlc | 88.5 ± 41.0 | 88.3 ± 31.6 |
HDL cholesterol, mg/dlc | 48.6 ± 12.9 | 50.1 ± 14.7 |
Triglycerides, mg/dlc | 170.3 ± 104.3 | 157.5 ± 92.5 |
Glucose-lowering therapy, n (%) | 257 (94.5) | 270 (95.4) |
Insulin | 147 (54.0) | 153 (54.1) |
Metformin | 137 (50.4) | 134 (47.3) |
Sulfonylureas | 98 (36.0) | 105 (37.1) |
Number of background glucose-lowering therapies, n (%) | ||
1 | 105 (38.6) | 116 (41.0) |
2 | 116 (42.6) | 113 (39.9) |
3 | 32 (11.8) | 30 (10.6) |
≥ 4 | 4 (1.5) | 6 (2.1) |
Antihypertensives, n (%) | 267 (98.2) | 268 (94.7) |
ACE inhibitors or ARBs | 224 (82.4) | 206 (72.8) |
Calcium antagonists | 167 (61.4) | 171 (60.4) |
β-Blockers | 143 (52.6) | 133 (47.0) |
Diuretics | 98 (36.0) | 94 (33.2) |
Aspirin, n (%) | 169 (62.1) | 175 (61.8) |
Statins, n (%) | 231 (84.9) | 224 (79.2) |
Data are mean ± SD for patients treated with ≥ 1 dose of study medication unless otherwise specified
ACE angiotensin-converting enzyme, ARB angiotensin receptor blocker, BMI body mass index, eGFR estimated glomerular filtration rate, HbA1c glycated hemoglobin, HDL high-density lipoprotein, LDL low-density lipoprotein, MDRD Modification of Diet in Renal Disease study equation, SD standard deviation, UACR urinary albumin-to-creatinine ratio
aData missing for 1 patient (linagliptin: n = 1)
bData missing for 17 patients (linagliptin: n = 11; placebo: n = 6)
cData missing for 7 patients (linagliptin: n = 4; placebo: n = 3)