Table II.
Baseline characteristics of study population.
| Male | Female | Total | |
|---|---|---|---|
| Total randomized | 9684 (63%) | 5796 (37%) | 15,480 (100%) |
| Age at randomization (years) | |||
| <50 | 582 (6%) | 507 (9%) | 1089 (7%) |
| ≥50, <60 | 2888 (30%) | 1613 (28%) | 4501 (29%) |
| ≥60, <70 | 3944 (41%) | 2303 (40%) | 6247 (40%) |
| ≥70 | 2270 (23%) | 1373 (24%) | 3643 (24%) |
| Mean age (SD) | 63.3 (9.1) | 63.1 (9.4) | 63.3 (9.2) |
| Body mass index (kg/m2)⁎ | |||
| <25 | 1385 (14%) | 864 (15%) | 2249 (15%) |
| ≥25, <30 | 3883 (40%) | 1646 (28%) | 5529 (36%) |
| ≥30, <35 | 2666 (28%) | 1574 (27%) | 4240 (27%) |
| ≥35 | 1449 (15%) | 1512 (26%) | 2961 (19%) |
| Unknown | 301 (3%) | 200 (3%) | 501 (3%) |
| Mean body mass index (SD) | 30.1 (5.6) | 31.7 (7.1) | 30.7 (6.3) |
| Type of diabetes† | |||
| Type 1 | 518 (5%) | 393 (7%) | 911 (6%) |
| Type 2 | 9166 (95%) | 5403 (93%) | 14,569 (94%) |
| Diabetes management | |||
| Diet only | 1502 (16%) | 1027 (18%) | 2529 (16%) |
| Any hypoglycemic agent but not insulin | 5816 (60%) | 3204 (55%) | 9020 (58%) |
| Insulin +/− other hypoglycemic agent | 2366 (24%) | 1565 (27%) | 3931 (25%) |
| Duration of diabetes (years) | |||
| <5 | 2991 (31%) | 1900 (33%) | 4891 (32%) |
| ≥5, <10 | 2728 (28%) | 1606 (28%) | 4334 (28%) |
| ≥10, <20 | 2287 (24%) | 1250 (22%) | 3537 (23%) |
| ≥ 20 | 1150 (12%) | 712 (12%) | 1862 (12%) |
| Unknown | 528 (5%) | 328 (6%) | 856 (6%) |
| Median duration of diabetes (IQR) | 7 (3–13) | 7 (3–12) | 7 (3–13) |
| Systolic blood pressure (mmHg)‡ | |||
| <130 | 1961 (20%) | 1433 (25%) | 3394 (22%) |
| ≥130, <140 | 1931 (20%) | 1160 (20%) | 3091 (20%) |
| ≥140 | 2965 (31%) | 1590 (27%) | 4555 (29%) |
| Unknown | 2827 (29%) | 1613 (28%) | 4440 (29%) |
| Mean systolic blood pressure (SD) | 136.9 (15.2) | 134.9 (15.3) | 136.2 (15.3) |
| Other Factors§ | |||
| Reported treated hypertension (n = 15,368) | 5854 (60%) | 3679 (63%) | 9533 (62%) |
| Current smoker (n = 15,307) | 778 (8%) | 501 (9%) | 1279 (8%) |
| Diabetic retinopathy (n = 15,336) | 1875 (19%) | 1148 (20%) | 3023 (20%) |
| Ethnic origin | |||
| White | 9331 (96%) | 5604 (97%) | 14,935 (96%) |
| Indian/Pakistani/Bangladeshi | 141 (1%) | 43 (<1%) | 184 (1%) |
| African/Caribbean | 79 (<1%) | 61 (1%) | 140 (<1%) |
| Other/unknown | 133 (1%) | 88 (2%) | 221 (1%) |
⁎
Based on self-reported height and weight
†
Based on a broad clinical definition involving age at diagnosis of diabetes, use of insulin within one year of diagnosis and BMI
‡
From blood and urine consent form, generally before randomization
§
Reported by participant on randomization questionnaire.