Table 1.
Baseline characteristics (after insulin therapy optimization) of participants randomized in the pooled analysis group
| Pooled analysis group (inTandem1 and inTandem2) |
|||
|---|---|---|---|
| Placebo | SOTA 200 mg | SOTA 400 mg | |
| Randomized, n | 526 | 524 | 525 |
| Age, years, mean (SD) | 42.5 (13.3) | 44.4 (13.7) | 44.0 (13.4) |
| Female, % | 48.5 | 49.4 | 51.8 |
| White race, % | 93.9 | 94.1 | 94.5 |
| Diabetes duration, years, mean (SD) | 21.2 (12.0) | 21.6 (12.5) | 21.5 (12.3) |
| CSII, %/MDI, % | 43.0/57.0 | 42.7/57.3 | 42.7/57.3 |
| BMI, kg/m2, mean (SD) | 28.5 (5.3) | 28.9 (5.6) | 28.7 (5.2) |
| Weight, kg, mean (SD) | 84.3 (17.6) | 84.5 (18.1) | 84.2 (18.1) |
| HbA1c, %, mean (SD) | 7.7 (0.8) | 7.7 (0.8) | 7.6 (0.8) |
| HbA1c, mmol/mol, mean (SD) | 60.3 (8.8) | 60.4 (8.4) | 60.0 (8.5) |
| Total daily insulin, IU/kg, mean (SD) | 0.75 (0.3) | 0.73 (0.3) | 0.73 (0.30) |
| SBP, mmHg, mean (SD) | 122.0 (14.6) | 121.5 (15.0) | 121.3 (14.3) |
| eGFR (MDRD), mL/min/1.73 m2 | |||
| Mean (SD) | 90.2 (18.5) | 89.3 (19.6) | 89.1 (18.3) |
| <60, n (%) | 24 (4.6) | 22 (4.2) | 25 (4.8) |
| ≥60, n (%) | 502 (95.4) | 502 (95.8) | 500 (95.2) |
| eGFR (CKD-EPI), mL/min/1.73 m2 | |||
| Mean (SD) | 98.2 (18.1) | 96.5 (18.3) | 97.0 (17.7) |
| <60, n (%) | 17 (3.2) | 16 (3.1) | 12 (2.3) |
| ≥60, n (%) | 509 (96.8) | 508 (96.9) | 513 (97.7) |
| UACR, mg/g | |||
| Geometric mean (CI) | 8.9 (8.0, 9.8) | 9.6 (8.7, 10.7) | 8.7 (7.9, 9.7) |
| Median (Q1:Q3) | 6.6 (4.3:13.0) | 7.0 (4.4:14.1) | 6.3 (4.2:12.3) |
| <30, n (%) | 451 (87.7) | 439 (85.6) | 450 (88.4) |
| Median (Q1:Q3) | 5.7 (4.1:9.2) | 6.1 (4.2:9.2) | 5.6 (4.0:9.4) |
| ≥30, n (%) | 63 (12.3) | 74 (14.4) | 59 (11.6) |
| Median (Q1:Q3) | 56.2 (35.7:197.2) | 61.3 (39.9:155.1) | 83.3 (48.0:305.0) |
CSII, continuous subcutaneous insulin infusion; MDI, multiple daily injections of insulin; Q, quartile.