Table 1. Baseline Participant Characteristicsa.
| Characteristics | Linagliptin (n = 3494) | Placebo (n = 3485) |
|---|---|---|
| Age, y | 66.1 (9.1) | 65.6 (9.1) |
| Sex, No. (%) | ||
| Male | 2148 (61.5) | 2242 (64.3) |
| Female | 1346 (38.5) | 1243 (35.7) |
| Race, No. (%) | ||
| White | 2827 (80.9) | 2769 (79.5) |
| Asian | 307 (8.8) | 333 (9.6) |
| Black/African American | 194 (5.6) | 217 (6.2) |
| Otherb | 166 (4.8) | 166 (4.8) |
| Region, No. (%) | ||
| Europe (plus South Africa) | 1473 (42.2) | 1461 (41.9) |
| Latin America | 1156 (33.1) | 1154 (33.1) |
| North America | 593 (17.0) | 587 (16.8) |
| Asia | 272 (7.8) | 283 (8.1) |
| Smoking status, No. (%) | ||
| Never smoker | 1897 (54.3) | 1856 (53.3) |
| Ex-smoker | 1231 (35.2) | 1276 (36.6) |
| Current smoker | 362 (10.4) | 350 (10.0) |
| Missing data | 4 (0.1) | 3 (0.1) |
| History of heart failure, No. (%) | 952 (27.2) | 921 (26.4) |
| Ischemic heart disease, No. (%) | 2029 (58.1) | 2052 (58.9) |
| History of hypertension, No. (%) | 3171 (90.8) | 3178 (91.2) |
| Atrial fibrillation, No. (%) | 319 (9.1) | 354 (10.2) |
| eGFR (MDRD), mL/min/1.73 m2 | 54.7 (25.1) | 54.5 (24.9) |
| No. (%) | ||
| ≥90 | 363 (10.4) | 365 (10.5) |
| ≥60 | 1294 (37.0) | 1337 (38.4) |
| ≥45 to <60 | 690 (19.7) | 658 (18.9) |
| ≥30 to <45 | 994 (28.4) | 944 (27.1) |
| <30 | 516 (14.8) | 546 (15.7) |
| UACR, median (IQR), mg/g | 162 (43-700) | 162 (44-750) |
| No. (%)c | ||
| <30 | 696 (20.0) | 696 (20.0) |
| 30-300 | 1463 (41.9) | 1431 (41.1) |
| >300 | 1333 (38.2) | 1357 (38.9) |
| Body mass indexd | 31.4 (5.3) | 31.3 (5.4) |
| Hemoglobin A1c, % | 7.9 (1.0) | 8.0 (1.0) |
| Fasting plasma glucose, mg/dL | 151.2 (45.0) | 151.2 (45.0) |
| Diabetes duration, y | 15.0 (9.6) | 14.5 (9.3) |
| Systolic blood pressure, mm Hg | 140.4 (17.7) | 140.6 (18.0) |
| Diastolic blood pressure, mm Hg | 77.8 (10.5) | 77.9 (10.4) |
| Heart rate, /min | 69.8 (12.2) | 69.8 (12.3) |
| Total cholesterol, mg/dL | 173 (49) | 171 (47) |
| Low-density lipoprotein cholesterol, mg/dL | 92 (40) | 91 (39) |
| High-density lipoprotein cholesterol, mg/dL | 45 (13) | 44 (13) |
| Triglycerides, mg/dL | 190 (136) | 187 (130) |
| ≥1 Glucose-lowering medication, No. (%) | 3378 (96.7) | 3376 (96.9) |
| Metformin | 1881 (53.8) | 1927 (55.3) |
| Sulfonylurea | 1102 (31.5) | 1140 (32.7) |
| Insulin | 2056 (58.8) | 1995 (57.2) |
| No. of background glucose-lowering therapies, No. (%) | ||
| 1 | 1756 (50.3) | 1769 (50.8) |
| 2 | 1424 (40.8) | 1420 (40.7) |
| 3 | 192 (5.5) | 180 (5.2) |
| ≥4 | 6 (0.2) | 7 (0.2) |
| ≥1 Antihypertensive medication, No. (%) | 3337 (95.5) | 3354 (96.2) |
| ACE inhibitors or ARBs | 2860 (81.9) | 2798 (80.3) |
| β-Blockers | 2080 (59.5) | 2073 (59.5) |
| Diuretics | 1892 (54.1) | 1936 (55.6) |
| Calcium antagonists | 1433 (41.0) | 1446 (41.5) |
| Aspirin, No. (%) | 2166 (62.0) | 2178 (62.5) |
| Statins, No. (%) | 2495 (71.4) | 2523 (72.4) |
Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; eGFR estimated glomerular filtration rate; IQR, interquartile range; MDRD, Modification of Diet in Renal Disease study equation; UACR, urinary albumin:creatinine ratio.
SI conversions: To convert glucose to mmol/L, multiply by 0.0555; to convert total, low-density lipoprotein, and high-density lipoprotein cholesterol to mmol/L, multiply by 0.0259; to convert triglycerides to mmol/L, multiply by 0.0113.
Data are expressed as mean (SD) unless otherwise specified.
American Indian/Alaska Native or Native Hawaiian/other Pacific Islander.
Data were missing for 3 patients: 2 (0.1%) in the linagliptin group and 1 (<0.1%) in the placebo group.
Calculated as weight in kilograms divided by height in meters squared.