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Table 2 Participant characteristics of individual studies (PDM-ProValue and CVOTs [intervention group])

From: PDM-ProValue meets cardiovascular outcome trials in diabetes

Study PDM-ProValue (1) Meta-analysis GLP-1 receptor agonists [29] Harmony outcomes [14] Insulin
iPDM ELIXA [10] LEADER [11] SUSTAIN6 [12] EXSCEL [13] DEVOTE [19]
Diabetes type T2DM T2DM T2DM T2DM T2DM T2DM T2DM
Insulin-treated (%) 100 39 43 58* 58** 46.2 60 84.2
Male (%) 60.5 69 64.5 59.9* 63** 62 70 62.8
Age (years), mean (SD) 64.5 (10.9) 59.9 ± 9.7 64.2 ± 7.2 64.6 ± 7.3* 64.7 ± 7.1** 62.0 64.1 (8.7) 64.9 ± 7.3
Time since diagnosis (years), mean (SD) 14.4 (8.7) 9.2 ± 8.2 12.8 ± 8.0 14.3 ± 8.2* 14.1 ± 8.2** 12.0 14.1 (8.6) 16.6 ± 8.8
Time since start of insulin therapy (years), mean (SD) 7.1 (6.6) nd nd nd nd nd nd
BMI, mean (SD) 33.8 (6.1) 30.1 ± 5.6 32.5 ± 6.3 32.7 (6.29)* 32.9 (6.18)** 31.8 32.3 (5.9) 33.6 ± 6.8
Baseline HbA1c (%), mean (SD) 8.5 (1.1) 7.7 ± 1.3 8.7 ± 1.6 8.7 ± 1.4* 8.7 ± 1.5** 8.0 8.76 (1.5) 8.4 ± 1.6
Change in HbA1c (%) − 0.5 − 0.6 − 1.1 − 1.1* − 1.4** − 0.4 − 0.9 − 0.9
Proportion with established CVD (%) nd 100 82 83 73 70 63.3
  1. nd not determined, T2DM type 2 diabetes mellitus
  2. * Semaglutide 0.5 mg; ** Semaglutide 1.0 mg; # In 57% of participants time since diagnosis of type 2 diabetes was > 10 years
Study SGLT-2 inhibitors DPP-4 inhibitors
CANVAS [16] EMPA-REG [15] DECLARE-TIMI 58 [17] TECOS [8] EXAMINE [7] SAVOR-TIMI [6] CARMELINA [9]
Diabetes type T2DM T2DM T2DM T2DM T2DM T2DM T2DM
Insulin-treated (%) 49.9 48 41.6 23.5 29.4 41.6 58.8
Male (%) 64.9 71.2 63.1 70.9 67.7 66.6 61.5
Age (years), mean (SD) 63.2 ± 8.3 63.1 ± 8.6 63.9 ± 6.8 65.4 ± 7.9 61.0 65.1 ± 8.5 66.1 (9.1)
Time since diagnosis (years), mean (SD) 13.5 ± 7.7 > 10# 11.0 11.6 ± 8.1 7.1 10.3 15.0 (9.6)
Time since start of insulin therapy (years), mean (SD) nd nd nd nd nd nd nd
BMI, mean (SD) 31.9 ± 5.9 30.6 ± 5.3 32.1 ± 6.0 30.2 ± 5.6 28.7 31.1 ± 5.5 31.4 (5.3)
Baseline HbA1c (%), mean (SD) 8.2 8.07 8.3 ± 1.2 7.2 8.0 8.0 7.9 (1.0)
Change in HbA1c (%) − 0.3 − 0.26 − 0.4 − 0.1 − 0.33 − 0.3 − 036
Proportion with established CVD (%) 64.8 99.4 41.6 73.6 100 78.4 58.1
  1. nd not determined, T2DM type 2 diabetes mellitus
  2. * Semaglutide 0.5 mg; ** Semaglutide 1.0 mg; # In 57% of participants time since diagnosis of type 2 diabetes was > 10 years