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 |
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 |