Introduction
iPDM—PDM-ProValue: Study design and outcomes
CVOTs in diabetes
PDM-ProValue and CVOTs: Comparison of patient characteristics
PDM-ProValue | CVOTs* | |
---|---|---|
Diabetes type | T2DM | T2DM |
Insulin-treated (%) | 100 | 23.5 to 84.2 |
Male (%) | 55.9 to 60.5 | 61 to 71.2 |
Age (years), mean | 64.5 to 64.9 | 59.9 to 65.4 |
Time since diagnosis (years), mean | 14.3 to 14.4 | 7 to 16.6 |
BMI (kg/m2), mean | 33.8 to 34.0 | 28.7 to 33.6 |
Baseline HbA1c (%) | 8.4 to 8.5 | 7.2 to 8.8 |
Change in HbA1c (%) | 0.2 to 0.5 | 0.1 to − 1.4 |
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 |
Role of SMBG in PDM-ProValue and CVOTs
SMBG reported on clinicaltrials.gov | SMBG mentioned in clinical study protocol | SMBG results reported in final publication | |
---|---|---|---|
DPP-4 inhibitors
| |||
SAVOR-TIMI | No (NCT01107886) | Yes | No (6) |
EXAMINE | No (NCT00968708) | No | No (7) |
TECOS | No (NCT00790205) | No | No (8) |
CARMELINA | No (NCT01897532) | Yes | No (9) |
SGLT-2 inhibitors
| |||
EMPA-REG OUTCOME | No (NCT01131676) | Yes | No (15) |
CANVAS | No (NCT01032629) | Yes | No (16) |
DECLARE-TIMI 58 | No (NCT01730534) | No | No (17) |
GLP-1 receptor agonist
| |||
ELIXA | No (NCT01147250) | Yes | No (10) |
SUSTAIN-6 | No (NCT01720446) | No | No (12) |
LEADER | No (NCT01179048) | Yes | No (11) |
EXCSEL | No (NCT01144338) | Not determined | No (13) |
Harmony outcomes | No (NCT02465515) | No | No (14) |
Insulin
| |||
DEVOTE | No (NCT01959529) | Yes | Yes (19) |