Table 1 Baseline characteristics and demographics of subjects in the SUSTAIN 6 trial
A. Post hoc analysis by gender | ||||
|---|---|---|---|---|
Semaglutide | Placebo | |||
Male | Female | Male | Female | |
Subject demographics | ||||
Full analysis set, N | 1013 | 635 | 989 | 660 |
Trial completers, n (%) | 959 (94.7) | 602 (94.8) | 926 (93.6) | 623 (94.4) |
Treatment completers, n (%) | 773 (76.3) | 481 (75.7) | 788 (79.7) | 514 (77.9) |
Baseline characteristicsa | ||||
Age, years | 64.6 (7.3) | 64.8 (7.1) | 64.6 (7.6) | 64.6 (7.5) |
Body weight, kg | 96.7 (20.5) | 85.4 (19.0) | 95.8 (21.0) | 86.0 (18.4) |
BMI, kg/m2 | 32.3 (5.9) | 33.7 (6.6) | 32.1 (6.0) | 33.9 (6.3) |
Diabetes duration, years | 13.9 (8.1) | 14.5 (8.4) | 13.5 (8.0) | 13.8 (8.1) |
HbA1c, % | 8.6 (1.4) | 8.8 (1.6) | 8.6 (1.4) | 8.8 (1.6) |
Smoking status (never/previous/current), % | 33.5/51.7/14.8 | 65.4/26.1/8.5 | 30.1/56.1/13.7 | 66.8/23.0/10.2 |
B. Post hoc analysis by age | ||||
|---|---|---|---|---|
Semaglutide | Placebo | |||
≤ 65 years | > 65 years | ≤ 65 years | > 65 years | |
Subject demographics | ||||
Full analysis set, N | 950 | 698 | 929 | 720 |
Trial completers, n (%) | 899 (94.6) | 662 (94.8) | 875 (94.2) | 674 (93.6) |
Treatment completers, n (%) | 745 (78.4) | 509 (72.9) | 745 (80.2) | 557 (77.4) |
Baseline characteristicsb | ||||
Age, years | 59.7 (4.1) | 71.4 (4.7) | 59.2 (4.3) | 71.6 (4.5) |
Females, % | 38.4 | 38.7 | 40.9 | 38.9 |
Body weight, kg | 94.0 (21.1) | 90.0 (19.8) | 93.0 (21.4) | 90.5 (19.3) |
BMI, kg/m2 | 33.3 (6.4) | 32.2 (5.9) | 33.1 (6.4) | 32.4 (5.8) |
Diabetes duration, years | 12.6 (7.2) | 16.4 (8.9) | 12.4 (7.4) | 15.2 (8.5) |
HbA1c, % | 8.9 (1.6) | 8.4 (1.2) | 8.9 (1.6) | 8.4 (1.3) |
Smoking status (never/previous/current), % | 47.0/37.1/16.0 | 44.1/48.4/7.5 | 45.3/39.0/15.7 | 44.2/47.9/7.8 |
C. Post hoc analyses by CV risk profile at baseline | ||||||||
|---|---|---|---|---|---|---|---|---|
Semaglutide | Placebo | Semaglutide | Placebo | |||||
Prior MI/stroke | No prior MI/stroke | Prior MI/stroke | No prior MI/stroke | Established CVD | CV risk factors | Established CVD | CV risk factors | |
Full analysis set, N | 673 | 975 | 694 | 955 | 1262 | 386 | 1271 | 378 |
Baseline characteristics | ||||||||
Age, years | 63.8 (7.5) | 65.2 (6.9) | 63.6 (7.9) | 65.3 (7.2) | 64.2 (7.3) | 66.1 (6.5) | 64.2 (7.7) | 66.0 (6.7) |
Female, n (%) | 208 (30.9) | 427 (43.8) | 225 (32.4) | 435 (45.5) | 445 (35.3) | 190 (49.2) | 463 (36.4) | 197 (52.1) |
Diabetes duration, years | 13.7 (8.5) | 14.5 (8.0) | 13.3 (8.1) | 13.8 (8.0) | 14.0 (8.4) | 14.8 (7.6) | 13.3 (7.9) | 14.6 (8.2) |
BMI, kg/m2 | 32.6 (6.0) | 33.0 (6.4) | 32.7 (6.2) | 32.8 (6.2) | 32.8 (6.1) | 32.8 (6.5) | 33.0 (6.2) | 32.3 (6.1) |
HbA1c, % | 8.8 (1.6) | 8.7 (1.4) | 8.7 (1.5) | 8.7 (1.4) | 8.7 (1.5) | 8.7 (1.4) | 8.7 (1.5) | 8.7 (1.5) |
CV risk factors | ||||||||
Systolic blood pressure, mmHg | 134.6 (17.7) | 136.9 (17.3) | 134.9 (17.1) | 135.5 (16.6) | 135.5 (17.5) | 137.5 (17.5) | 134.9 (16.6) | 136.5 (17.4) |
Diastolic blood pressure, mmHg | 76.8 (9.9) | 77.1 (10.1) | 76.7 (10.4) | 77.4 (9.8) | 76.7 (10.0) | 77.9 (9.8) | 77.0 (10.2) | 77.5 (9.6) |
Total cholesterol, mmol/L [mean (CoV)] | 4.2 (26.8) | 4.4 (25.5) | 4.2 (27.9) | 4.3 (26.5) | 4.3 (26.9) | 4.4 (23.6) | 4.2 (27.6) | 4.4 (25.4) |
eGFR, mL/min/1.73 m2 [mean (CoV)] | 72.1 (39.2) | 70.1 (41.4) | 73.8 (39.8) | 69.0 (44.6) | 72.9 (38.7) | 64.9 (44.8) | 73.9 (39.7) | 61.7 (49.2) |
Current smoker, n (%) | 106 (15.8) | 98 (10.1) | 109 (15.7) | 93 (9.74) | 170 (13.5) | 34 (8.8) | 167 (13.1) | 35 (9.3) |
Manifestation of CVD | ||||||||
Prior MI, n (%) | 530 (78.8) | – | 542 (78.1) | – | 530 (42.0) | – | 542 (42.6) | – |
Ischemic heart disease, n (%) | 571 (84.8) | 417 (42.8) | 589 (84.9) | 417 (43.7) | 988 (78.3) | – | 1006 (79.2) | – |
Prior stroke, n (%) | 191 (28.4) | – | 210 (30.3) | – | 191 (15.1) | – | 210 (16.5) | – |
Peripheral arterial disease, n (%) | 87 (12.9) | 139 (14.3) | 89 (12.8) | 138 (14.5) | 226 (17.9) | – | 227 (17.9) | – |
≥ 50% arterial stenosis, n (%) | 327 (48.6) | 240 (24.6) | 361 (52.0) | 239 (25.0) | 567 (44.9) | – | 600 (47.2) | – |
Percutaneous coronary intervention, n (%) | 327 (48.6) | 163 (16.7) | 342 (49.3) | 180 (18.8) | 490 (38.8) | – | 522 (41.1) | – |
Coronary artery bypass graft, n (%) | 182 (27.0) | 106 (10.9) | 182 (26.2) | 107 (11.2) | 288 (22.8) | – | 289 (227) | – |
Heart failure, n (%) | 187 (27.8) | 194 (19.9) | 185 (26.7) | 211 (22.1) | 381 (30.2) | – | 396 (31.2) | – |