Table 1 Baseline characteristics of the trial participants categorized by racial group

Age at randomization (years)

62 (56, 68)

63 (57, 69)

60 (54, 66)

61 (55, 68)

60 (53, 66)

Male

62.0%

63.8%

62.3%

54.9%

47.6%

Region

 Europe

46.0%

58.9%

7.8%

1.6%

8.4%

 North America

25.1%

25.1%

8.3%

28.6%

49.1%

 Latin America

18.4%

13.3%

0.5%

68.5%

42.4%

 Asia Pacific

10.4%

2.7%

83.4%

1.3%

0.1%

Diabetes duration (years)

12 (7, 18)

12 (7, 18)

11 (7, 18)

13 (7, 19)

11 (6, 17)

Diabetes therapy (alone/in combination)

 Metformin

76.7%

76.5%

76.5%

80.5%

73.9%

 Sulfonylurea/other secretagogue

37.9%

37.0%

44.0%

35.5%

43.1%

 Alpha-glucosidase inhibitor

2.0%

1.1%

11.1%

0.7%

0.6%

 Thiazolidinedione

3.9%

3.8%

5.1%

3.4%

5.3%

 Incretin-based therapies

15.0%

15.9%

17.7%

8.6%

7.7%

 Insulin

46.2%

46.1%

47.5%

48.7%

42.1%

Smoking status

 Never/former

88.3%

88.3%

86.6%

92.3%

86.6%

 Current

11.7%

11.7%

13.4%

7.7%

13.4%

 Prior cardiovascular disease

73.3%

73.0%

77.4%

72.2%

71.7%

 Prior coronary artery disease

52.7%

53.5%

58.8%

50.5%

36.6%

 Prior cerebrovascular disease

17.0%

17.4%

20.2%

12.0%

13.1%

 Prior peripheral arterial disease

18.9%

18.8%

19.9%

19.0%

12.9%

 Prior congestive heart failure

16.1%

18.8%

5.4%

8.6%

9.3%

Cardiovascular medications

 Statins

73.5%

74.9%

74.7%

66.2%

63.9%

 ACE inhibitors/angiotensin receptor blockers

77.3%

79.3%

67.1%

74.6%

71.7%

 Diuretics

43.6%

47.2%

19.9%

34.4%

49.9%

 Calcium channel blockers

32.0%

31.7%

39.0%

25.0%

33.3%

 Beta blockers

55.7%

58.8%

48.0%

45.2%

43.4%

 Aspirin

63.6%

63.9%

61.4%

68.6%

55.9%

 Other platelet function antagonists

3.8%

3.4%

7.3%

3.4%

3.2%

Height (cm)

168 (160, 175)

170 (162, 176)

164 (157, 170)

163 (155, 170)

165 (157, 173)

Weight (kg)

90 (77, 103)

94 (82, 108)

71 (62, 81)

80 (69, 93)

88 (75, 103)

Body mass index (kg/m²)

31.8 (28.2, 36.2)

32.6 (29.2, 36.9)

26.7 (24.2, 29.7)

30.3 (27.0, 34.2)

31.9 (28.5, 36.7)

Pulse rate (beats/min)

72 (66, 80)

72 (66, 80)

74 (70, 84)

72 (65, 79)

72 (65, 80)

Systolic blood pressure (mmHg)

135 (124, 145)

135 (125, 146)

130 (120, 142)

130 (120, 142)

136 (125, 149)

Diastolic blood pressure (mmHg)

80 (70, 85)

80 (70, 85)

78 (70, 84)

79 (70, 84)

80 (73, 86)

Qualifying HbA_1c (mmol/mol)

64 (56, 74)

63 (56, 73)

65 (57, 74)

65 (57, 76)

65 (56, 75)

Qualifying HbA_1c (%)

8.0 (7.3, 8.9)

7.9 (7.3, 8.8)

8.1 (7.4, 8.9)

8.1 (7.4, 9.1)

8.1 (7.3, 9.0)

eGFR (mL/min/1.73 m²)

75 (61, 90)

74 (60, 89)

76 (60, 94)

75 (61, 92)

83 (67, 99)

Urine albumin:creatinine ratio (mg/mmol)

1.6 (0.5, 5.7)

1.5 (0.5, 5.1)

2.1 (0.5, 10.1)

1.9 (0.4, 7.8)

2.5 (0.5, 10.2)

Serum LDL cholesterol

2.3 (1.7, 3.0)

2.2 (1.7, 3.0)

2.2 (1.7, 2.9)

2.3 (1.7, 2.9)

2.5 (2.0, 3.3)

Serum HDL cholesterol

1.09 (0.91, 1.29)

1.09 (0.90, 1.29)

1.09 (0.90, 1.27)

1.06 (0.91, 1.24)

1.16 (0.98, 1.35)

Serum triglycerides

1.8 (1.3, 2.6)

1.8 (1.3, 2.6)

1.6 (1.2, 2.3)

1.9 (1.3, 2.7)

1.5 (1.1, 2.3)