TABLE 1.
Baseline characteristics in the overall population and by baseline HbA1c value
| Overall (n = 17,605) | HbA1c <5.7% (n = 5904) | HbA1c ≥5.7% to <6.0% (n = 6087) | HbA1c ≥6.0% to <6.5% (n = 5609) | |
|---|---|---|---|---|
| CV inclusion criteria, n (%) a | ||||
| MI only | 11,908 (67.6) | 3861 (65.4) | 4198 (69.0) | 3846 (68.6) |
| Stroke only | 3135 (17.8) | 1199 (20.3) | 1049 (17.2) | 886 (15.8) |
| PAD only | 777 (4.4) | 254 (4.3) | 254 (4.2) | 269 (4.8) |
| ≥2 CV inclusion criteria | 1433 (8.1) | 470 (8.0) | 469 (7.7) | 493 (8.8) |
| Demographics | ||||
| Age (y), mean (SD) | 61.6 (8.9) | 61.0 (9.1) | 61.7 (8.8) | 62.1 (8.6) |
| Age group (y), n (%) | ||||
| 45 to <55 | 4150 (23.6) | 1599 (27.1) | 1400 (23.0) | 1150 (20.5) |
| 55 to <65 | 6727 (38.2) | 2149 (36.4) | 2365 (38.9) | 2211 (39.4) |
| 65 to <75 | 5362 (30.5) | 1707 (28.9) | 1848 (30.4) | 1806 (32.2) |
| 75 to <85 | 1318 (7.5) | 435 (7.4) | 458 (7.5) | 424 (7.6) |
| ≥85 | 48 (0.3) | 14 (0.2) | 16 (0.3) | 18 (0.3) |
| Male, n (%) | 12,733 (72.3) | 4274 (72.4) | 4409 (72.4) | 4046 (72.1) |
| Region, n (%) | ||||
| North America | 4401 (25.0) | 1717 (29.1) | 1423 (23.4) | 1259 (22.4) |
| South America | 1152 (6.5) | 494 (8.4) | 385 (6.3) | 273 (4.9) |
| Europe | 6507 (37.0) | 1834 (31.1) | 2380 (39.1) | 2291 (40.8) |
| Africa | 845 (4.8) | 273 (4.6) | 280 (4.6) | 292 (5.2) |
| Asia | 2201 (12.5) | 722 (12.2) | 757 (12.4) | 722 (12.9) |
| Other | 2499 (14.2) | 864 (14.6) | 862 (14.2) | 772 (13.8) |
| Race, n (%) b | ||||
| Asian | 1447 (8.2) | 446 (7.6) | 501 (8.2) | 500 (8.9) |
| Black | 671 (3.8) | 228 (3.9) | 214 (3.5) | 228 (4.1) |
| White | 14,791 (84.0) | 5033 (85.2) | 5120 (84.1) | 4634 (82.6) |
| Other c | 527 (3.0) | 160 (2.7) | 191 (3.1) | 176 (3.1) |
| Ethnicity, n (%) d | ||||
| Hispanic or Latino | 1822 (10.3) | 755 (12.8) | 594 (9.8) | 473 (8.4) |
| Not Hispanic or Latino | 15,612 (88.7) | 5111 (86.6) | 5431 (89.2) | 5065 (90.3) |
| Tobacco use, n (%) | ||||
| Current smoker | 2950 (16.8) | 834 (14.1) | 1069 (17.6) | 1046 (18.6) |
| Never smoked | 6123 (34.8) | 2275 (38.5) | 2048 (33.6) | 1800 (32.1) |
| Previous smoker | 8530 (48.5) | 2794 (47.3) | 2970 (48.8) | 2762 (49.2) |
| Body measurements | ||||
| BMI (kg/m2), mean (SD) | 33.34 (5.04) | 32.84 (4.83) | 33.23 (4.94) | 33.97 (5.29) |
| BMI (kg/m2), n (%) | ||||
| <30 | 5024 (28.5) | 1895 (32.1) | 1747 (28.7) | 1382 (24.6) |
| 30 to <35 | 7475 (42.5) | 2521 (42.7) | 2638 (43.3) | 2314 (41.3) |
| 35 to <40 | 3346 (19.0) | 1002 (17.0) | 1117 (18.4) | 1225 (21.8) |
| 40 to <45 | 1174 (6.7) | 330 (5.6) | 403 (6.6) | 440 (7.8) |
| ≥45 | 586 (3.3) | 156 (2.6) | 182 (3.0) | 248 (4.4) |
| Waist to height ratio (cm/cm), mean (SD) | 0.6558 (0.0764) | 0.6463 (0.0741) | 0.6550 (0.0769) | 0.6664 (0.0770) |
| Waist to height ratio tertiles, n (%) | ||||
| Lower tertile, ≤0.6176 | 5833 (33.1) | 2270 (38.4) | 2030 (33.3) | 1532 (27.3) |
| Middle tertile, >0.6176 to ≤0.6757 | 5858 (33.3) | 1945 (32.9) | 2048 (33.6) | 1864 (33.2) |
| Upper tertile, >0.6757 | 5827 (33.1) | 1657 (28.1) | 1981 (32.5) | 2186 (39.0) |
| Waist circumference (cm), mean (SD) | 111.4 (13.2) | 110.0 (12.9) | 111.2 (13.2) | 113.1 (13.4) |
| Body weight (kg), mean (SD) | 96.68 (17.67) | 95.57 (17.12) | 96.30 (17.32) | 98.25 (18.47) |
| Body weight (kg), n (%) | ||||
| <85 | 4617 (26.2) | 1647 (27.9) | 1603 (26.3) | 1367 (24.4) |
| 85 to <95 | 4469 (25.4) | 1549 (26.2) | 1604 (26.4) | 1316 (23.5) |
| 95 to <105 | 3693 (21.0) | 1257 (21.3) | 1242 (20.4) | 1193 (21.3) |
| ≥105 | 4826 (27.4) | 1451 (24.6) | 1638 (26.9) | 1733 (30.9) |
| Glycemic variables | ||||
| HbA1c (%), mean (SD) | 5.78 (0.34) | 5.42 (0.20) | 5.80 (0.08) | 6.15 (0.18) |
| HbA1c (mmol/mol), mean (SD) | 39.71 (3.68) | 35.72 (2.13) | 39.88 (0.88) | 43.74 (1.95) |
| Renal variables | ||||
| eGFR (mL/min/1.73 m2), mean (SD) | 82.5 (17.4) | 83.2 (17.6) | 82.1 (17.5) | 82.2 (17.1) |
| Renal function, eGFR (mL/min/1.73 m2), n (%) | ||||
| Normal, ≥90 | 6990 (39.7) | 2459 (41.6) | 2363 (38.8) | 2167 (38.6) |
| Mild RI, 60 to <90 | 8577 (48.7) | 2791 (47.3) | 2994 (49.2) | 2790 (49.7) |
| Moderate RI, 30 to <60 | 1826 (10.4) | 575 (9.7) | 655 (10.8) | 595 (10.6) |
| Severe RI, 15 to <30 | 69 (0.4) | 29 (0.5) | 23 (0.4) | 17 (0.3) |
| End‐stage renal disease, <15 | 2 (<0.1) | 2 (<0.1) | 0 | 0 |
| Albumin/creatinine ratio (mg/g), median (IQR) e | 7.37 (4.46‐15.39) | 7.15 (4.32‐14.80) | 7.26 (4.44‐14.67) | 7.79 (4.65‐16.56) |
| Albuminuria (mg/g), n (%) | ||||
| Normoalbuminuria, <30 | 14,846 (84.3) | 4991 (84.5) | 5165 (84.9) | 4687 (83.6) |
| Microalbuminuria, 30 to <300 | 1968 (11.2) | 634 (10.7) | 668 (11.0) | 666 (11.9) |
| Macroalbuminuria, ≥300 | 325 (1.8) | 117 (2.0) | 91 (1.5) | 117 (2.1) |
| eGFR <60 mL/min/1.73 m2 or UACR ≥30 mg/g, n (%) | 3697 (21.0) | 1197 (20.3) | 1270 (20.9) | 1229 (21.9) |
| Lipid and C‐reactive protein levels | ||||
| High‐sensitivity C‐reactive protein (mg/L), median (IQR) | 1.83 (0.87‐4.12) | 1.66 (0.81‐3.72) | 1.80 (0.85‐4.01) | 2.08 (0.96‐4.54) |
| Total cholesterol (mmol/L), median (IQR) | 3.97 (3.39‐4.73) | 4.02 (3.39‐4.79) | 3.96 (3.39‐4.70) | 3.93 (3.39‐4.67) |
| LDL‐C (mmol/L), median (IQR) | 2.02 (1.57‐2.64) | 2.05 (1.59‐2.69) | 2.02 (1.58‐2.63) | 2.00 (1.56‐2.60) |
| HDL‐C (mmol/L), median (IQR) | 1.13 (0.96‐1.34) | 1.17 (0.99‐1.40) | 1.13 (0.97‐1.34) | 1.09 (0.94‐1.29) |
| Triglycerides (mmol/L), median (IQR) | 1.52 (1.11‐2.12) | 1.43 (1.05‐2.02) | 1.52 (1.11‐2.10) | 1.60 (1.19‐2.24) |
| Free fatty acids (mmol/L), median (IQR) | 0.30 (0.17‐0.48) | 0.30 (0.16‐0.48) | 0.29 (0.16‐0.47) | 0.31 (0.18‐0.48) |
| VLDL‐C (mmol/L), median (IQR) | 0.68 (0.50‐0.95) | 0.64 (0.47‐0.91) | 0.68 (0.50‐0.95) | 0.72 (0.54‐1.01) |
| Blood pressure and heart rate | ||||
| Systolic blood pressure (mmHg), mean (SD) | 131.0 (15.4) | 130.4 (15.4) | 131.0 (15.5) | 131.6 (15.4) |
| Diastolic blood pressure (mmHg), mean (SD) | 79.3 (10.0) | 79.3 (10.0) | 79.4 (10.0) | 79.2 (9.9) |
| Pulse (beats/min), mean (SD) | 68.8 (10.7) | 68.5 (10.7) | 68.5 (10.6) | 69.4 (10.7) |
| Patient‐reported outcomes | ||||
| EQ‐VAS score, mean (SD) | 77.15 (15.68) | 77.83 (15.68) | 77.08 (15.60) | 76.49 (15.73) |
| EQ‐5D index score, mean (SD) | 0.88 (0.15) | 0.88 (0.15) | 0.88 (0.15) | 0.88 (0.14) |
| WRSS total score, mean (SD) | 1.13 (0.77) | 1.08 (0.77) | 1.13 (0.77) | 1.16 (0.77) |
Note: Baseline is defined as the assessment from the randomization visit (or the screening visit if the assessment from the randomization visit was not available). Data for all variables were not obtained for the entire population. Smoking is defined as at least one cigarette or equivalent daily. Tertiles are based on the overall population. The eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) formula; the renal function categories are based on the eGFR as per CKD‐EPI.
Abbreviations: CV, cardiovascular; eGFR, estimated glomerular filtration rate; EQ‐5D, EuroQoL 5 Dimensions; EQ‐VAS, EuroQoL Visual Analog Scale; HbA1c, glycated hemoglobin; HDL‐C, high‐density lipoprotein cholesterol; LDL‐C, low‐density lipoprotein cholesterol; MI, myocardial infarction; PAD, peripheral artery disease; RI, renal impairment; UACR, urinary albumin/creatinine ratio; VLDL‐C, very low‐density lipoprotein cholesterol; WRSS, weight‐related sign and symptom.
Participants were randomized in error and did not fulfill the CV inclusion criteria and/or participants for whom it is unknown whether only one or several of the inclusion criteria were fulfilled are not part of the following (overall population: n = 352; 2.0%). Of these 352 participants, 315 participants (1.8%) fulfilled at least one of the inclusion criteria and 37 (0.2%) were randomized in error.
Race was not reported for some participants (overall population: n = 169; 1.0%).
The category “Other” for race includes participants whose race was recorded as “American Indian or Alaska Native,” “Native Hawaiian or Pacific Islander,” or “Other.”
Ethnicity was not reported for some participants (overall population: n = 171; 1.0%).
To convert albumin/creatinine ratio from mg/g to mg/mmol, divide the mg/g value by 8.849557522.