Table 1.
Baseline characteristics and demographics by CKD class or albuminuria status at baseline (full analysis set)
| Parameter | Patients with CKD (eGFR <60 ml/min per 1.73 m2) | Patients without CKD (eGFR ≥60 ml/min/1.73 m2) | Patients with Albuminuria (UACR ≥30 mg/g)a | Patients without Albuminuria (UACR <30 mg/g)b | ||||
|---|---|---|---|---|---|---|---|---|
| Liraglutide | Placebo | Liraglutide | Placebo | Liraglutide | Placebo | Liraglutide | Placebo | |
| N | 1116 | 1042 | 3552 | 3630 | 1684 | 1738 | 2894 | 2821 |
| Age, yr (SD) | 67 (8) | 67 (8) | 63 (7) | 64 (7) | 65 (7) | 65 (7) | 64 (7) | 64 (7) |
| Sex, male % | 62 | 61 | 65 | 65 | 68 | 68 | 63 | 62 |
| Region, N (%) | ||||||||
| Europe | 332 (30) | 326 (31) | 1307 (37) | 1331 (37) | 536 (32) | 533 (31) | 1066 (37) | 1092 (39) |
| North America | 404 (36) | 387 (37) | 997 (28) | 1059 (29) | 512 (30) | 571 (33) | 864 (30) | 832 (30) |
| Asia | 109 (10) | 69 (7) | 251 (7) | 282 (8) | 176 (11) | 162 (9) | 182 (6) | 186 (7) |
| Rest of the world | 271 (24) | 260 (25) | 997 (28) | 958 (26) | 460 (27) | 472 (27) | 782 (27) | 711 (25) |
| Race, N (%) | ||||||||
| White | 847 (76) | 786 (75) | 2769 (78) | 2836 (78) | 1242 (74) | 1269 (73) | 2306 (80) | 2266 (80) |
| Black | 77 (7) | 107 (10) | 293 (8) | 300 (8) | 142 (8) | 181 (10) | 219 (8) | 218 (8) |
| Asian | 135 (12) | 96 (9) | 336 (10) | 369 (10) | 223 (13) | 209 (12) | 244 (8) | 247 (9) |
| Other | 57 (5) | 53 (5) | 154 (4) | 125 (3) | 77 (5) | 79 (5) | 125 (4) | 90 (3) |
| eGFR, ml/min per 1.73 m2 (SD) | 46 (11) | 46 (11) | 91 (22) | 91 (22) | 74 (30) | 75 (29) | 84 (26) | 84 (26) |
| Normal (eGFR ≥90 ml/min per 1.73 m2), N (%) | 0 (0) | 0 (0) | 1620 (46) | 1655 (46) | 475 (28) | 509 (29) | 1112 (38) | 1104 (39) |
| Mild impairment (eGFR 60–89 ml/min per 1.73 m2), N (%) | 0 (0) | 0 (0) | 1932 (54) | 1975 (54) | 626 (37) | 682 (39) | 1277 (44) | 1246 (44) |
| Moderate impairment (eGFR 30–59 ml/min per 1.73 m2), N (%) | 999 (90) | 935 (90) | 0 (0) | 0 (0) | 498 (30) | 464 (27) | 477 (17) | 451 (16) |
| Severe impairment (eGFR <30 ml/min per 1.73 m2), N (%) | 117 (11) | 107 (10) | 0 (0) | 0 (0) | 85 (5) | 83 (5) | 28 (1) | 20 (1) |
| Diabetes duration, yr (SD) | 15 (9) | 15 (9) | 12 (8) | 12 (8) | 14 (8) | 14 (8) | 12 (8) | 12 (8) |
| Prior stroke/MI, N (%) | 437 (39) | 424 (41) | 1566 (44) | 1567 (43) | 683 (41) | 708 (41) | 1280 (44) | 1239 (44) |
| History of MI | 325 (29) | 294 (28) | 1139 (32) | 1106 (31) | 506 (30) | 500 (29) | 935 (32) | 866 (31) |
| History of stroke | 177 (16) | 183 (18) | 553 (16) | 594 (16) | 247 (15) | 279 (16) | 463 (16) | 479 (17) |
| Hypertension, N (%) | 1067 (96) | 998 (96) | 3194 (90) | 3252 (90) | 1578 (94) | 1624 (93) | 2603 (90) | 2523 (89) |
| Body weight, kg | 91 (21) | 91 (22) | 92 (21) | 92 (20) | 91 (22) | 91 (22) | 92 (21) | 92 (20) |
| Body mass index, kg/m2 | 32 (6) | 33 (7) | 33 (6) | 32 (6) | 32 (6) | 32 (6) | 33 (6) | 33 (6) |
| HbA1c, % (SD) | 8.7 (1.6) | 8.6 (1.5) | 8.7 (1.5) | 8.7 (1.5) | 9.1 (1.7) | 8.9 (1.6) | 8.5 (1.4) | 8.5 (1.4) |
| Creatinine, mg/dl (SD)c | 1.5 (0.6) | 1.5 (0.6) | 0.8 (0.2) | 0.8 (0.2) | 1.1 (0.6) | 1.1 (0.6) | 0.9 (0.3) | 0.9 (0.3) |
| UACR, mg/g (IQR)d | 47 (229) | 52 (298) | 16 (40) | 17 (44) | 157 (303) | 163 (343) | 6 (10) | 6 (10) |
| Total cholesterol, mg/dl (SD)c | 172 (47) | 172 (47) | 172 (47) | 172 (47) | 176 (47) | 176 (51) | 172 (43) | 172 (43) |
| LDL, mg/dl)c | 90 (39) | 90 (35) | 90 (35) | 90 (35) | 94 (39) | 94 (39) | 90 (35) | 90 (35) |
| Systolic BP, mm Hg (SD) | 136 (20) | 137 (20) | 136 (17) | 136 (17) | 141 (19) | 140 (19) | 133 (17) | 134 (16) |
| Diastolic BP; mm Hg (SD) | 75 (11) | 76 (11) | 78 (10) | 77 (10) | 79 (11) | 78 (11) | 77 (10) | 77 (10) |
| Heart rate, bpm (SD) | 72 (12) | 72 (12) | 73 (11) | 73 (11) | 73 (12) | 73 (12) | 72 (11) | 72 (11) |
Data are mean (SD) or number of patients (n, proportion [%]) of patients either with eGFR <60 ml/min per 1.73 m2 or eGFR ≥60 ml/min per 1.73 m2. UACR, urinary albumin-creatinine ratio; MI, myocardial infarction; HbA1c, glycated hemoglobin; IQR, interquartile range.
a
Including macroalbuminuria (baseline UACR >300 mg/g) and microalbuminuria (baseline UACR ≥30 to ≤300 mg/g).
b
Including normoalbuminuria (baseline UACR <30 mg/g).
c
Calculated not measured.
d
UACR is geometric mean (IQR).