Table 2.
Baseline characteristics for the background medication subgroup analysis (i) and the insulin regimen subgroup analysis (ii)
| (i) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Trial | Background medication | Patients, N | Female, n (%) | Age, years | HbA1c, % | Duration of diabetes, years | Body weight, kg | BMI, kg/m2 | eGFR, ml/min/1.73 m2 |
| PIONEER 3 | Met | 493 | 221 (44.8) | 57 ± 10 | 8.1 ± 0.8 | 7.7 ± 5.7 | 92.0 ± 22.1 | 32.4 ± 6.4 | 97 ± 16 |
| SU + met | 439 | 226 (51.5) | 59 ± 9 | 8.4 ± 0.9 | 10.0 ± 6.2 | 90.0 ± 20.5 | 32.4 ± 6.1 | 94 ± 16 | |
| PIONEER 4 | Met | 528 | 265 (50.2) | 57 ± 10 | 7.9 ± 0.7 | 7.3 ± 5.7 | 93.1 ± 20.3 | 32.9 ± 6.1 | 95 ± 14 |
| SGLT2i + met | 183 | 76 (41.5) | 55 ± 9 | 8.0 ± 0.6 | 8.4 ± 5.1 | 96.7 ± 22.9 | 33.1 ± 6.7 | 97 ± 15 | |
| PIONEER 5 | Met | 77 | 34 (44.2) | 70 ± 8 | 7.8 ± 0.7 | 10.6 ± 6.7 | 89.2 ± 15.4 | 31.7 ± 4.6 | 50 ± 10 |
| SU ± met | 132 | 75 (56.8) | 71 ± 8 | 8.0 ± 0.7 | 13.1 ± 6.8 | 89.1 ± 17.6 | 32.0 ± 5.7 | 48 ± 9 | |
| Ins ± met | 115 | 59 (51.3) | 70 ± 8 | 8.0 ± 0.7 | 17.3 ± 8.9 | 94.0 ± 18.7 | 33.3 ± 5.6 | 46 ± 10 | |
| PIONEER 7 | Met | 189 | 79 (41.8) | 57 ± 10 | 8.2 ± 0.6 | 7.2 ± 4.9 | 92.1 ± 20.2 | 32.2 ± 6.3 | 97 ± 16 |
| SU ± met | 244 | 110 (45.1) | 58 ± 9 | 8.4 ± 0.6 | 9.8 ± 6.8 | 85.8 ± 19.8 | 31.1 ± 6.5 | 96 ± 14 | |
| SGLT2i ± met | 51 | 21 (41.2) | 58 ± 10 | 8.3 ± 0.6 | 8.5 ± 5.1 | 89.1 ± 15.9 | 30.8 ± 4.7 | 94 ± 13 | |
| Other | 20 | 9 (45.0) | 59 ± 13 | 8.2 ± 0.6 | 11.8 ± 8.1 | 89.4 ± 22.0 | 32.0 ± 6.7 | 96 ± 14 | |
| PIONEER 8 | Ins | 118 | 45 (38.1) | 62 ± 11 | 8.2 ± 0.7 | 16.0 ± 8.7 | 75.4 ± 19.2 | 27.6 ± 5.5 | 90 ± 14 |
| Ins + met | 247 | 130 (52.6) | 60 ± 9 | 8.2 ± 0.7 | 13.6 ± 7.4 | 90.0 ± 20.4 | 32.5 ± 6.2 | 92 ± 15 | |
| (ii) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Insulin regimen in PIONEER 8 | Patients, N | Female, n (%) | Age, years | HbA1c, % | Duration of diabetes, years | Body weight, kg | BMI, kg/m2 | eGFR, ml/min/1.73 m2 | Total daily insulin dose, U |
| Basal | 156 | 70 (44.9) | 60.2 ± 9.6 | 8.2 ± 0.7 | 13.0 ± 7.0 | 85.0 ± 20.2 | 30.4 ± 5.6 | 92 ± 14 | 35 ± 29 |
| Premixed | 67 | 31 (46.3) | 59.5 ± 11.7 | 8.2 ± 0.6 | 14.4 ± 9.2 | 78.4 ± 20.0 | 29.2 ± 6.6 | 91 ± 17 | 48 ± 31 |
| Basal-bolus | 142 | 74 (52.1) | 61.6 ± 8.9 | 8.2 ± 0.7 | 16.0 ± 8.0 | 88.8 ± 22.0 | 32.2 ± 6.9 | 90 ± 13 | 79 ± 53 |
All baseline characteristic values shown are the mean ± standard deviation unless otherwise specified. (i) data are for patients receiving oral semaglutide 14 mg or flexibly dosed. (ii) data are for patients receiving oral semaglutide 14 mg or placebo. Other includes thiazolidinediones and other oral glucose-lowering medications
BMI body mass index, eGFR estimated glomerular filtration rate, HbA1c glycated haemoglobin, ins insulin, met metformin, N number of patients included in analyses, n number of patients with at least one event, SGLT2i sodium-glucose cotransporter-2 inhibitor, SU sulphonylurea