Table 1.
Baseline Demographics and Characteristics
| Characteristic | Placebo (n = 42) | Sotagliflozin 400 mg (n = 43) | Total (N = 85) |
|---|---|---|---|
| Mean age, years ± SD | 21.7 ± 3.6 | 22.8 ± 4.0 | 22.3 ± 3.8 |
| Female, n (%) | 23 (54.8) | 22 (51.2) | 45 (52.9) |
| Race, n (%) | |||
| Asian | 1 (2.4) | 0 | 1 (1.2) |
| Black | 6 (14.3) | 2 (4.7) | 8 (9.4) |
| White | 34 (81.0) | 41 (95.3) | 75 (88.2) |
| Other | 1 (2.4) | 0 | 1 (1.2) |
| Body weight, kg ± SD | 77.3 ± 14.6 | 83.7 ± 20.4 | 80.5 ± 18.0 |
| BMI, kg/m2 ± SD | 26.7 ± 5.0 | 29.4 ± 7.2 | 28.1 ± 6.3 |
| BMI ≥30 kg/m2, n (%) | 10 (23.8) | 18 (41.9) | 28 (32.9) |
| T1D duration, years ± SD | 11.9 ± 5.4 | 11.9 ± 6.2 | 11.9 ± 5.8 |
| Insulin delivery method, n (%) | |||
| CSII | 23 (54.8) | 23 (53.5) | 46 (54.1) |
| MDI | 19 (45.2) | 20 (46.5) | 39 (45.9) |
| Total daily insulin, IU/kg ± SD | 0.9 ± 0.3 | 0.8 ± 0.3 | 0.9 ± 0.3 |
| Ratio of bolus to total insulin ± SD | 0.5 ± 0.1 | 0.5 ± 0.2 | 0.5 ± 0.1 |
| A1C, % ± SD | 9.7 ± 0.9 | 9.9 ± 1.4 | 9.8 ± 1.2 |
| A1C, mmol/mol ± SD | 82.8 ± 10.2 | 85.1 ± 15.4 | 84.0 ± 13.1 |
| A1C at screening, n (%) | |||
| ≤10.0% | 19 (45.2) | 18 (41.9) | 37 (43.5) |
| >10.0% | 23 (54.8) | 25 (58.1) | 48 (56.5) |
| 2-h PPG, mg/dL ± SD | 208.8 ± 81.0 | 239.4 ± 96.3 | 224.1 ± 89.7 |
| FPG, mg/dL ± SD | 187.1 ± 75.6 | 199.2 ± 83.8 | 193.2 ± 79.6 |
| BHB (mmol/L) ± SD | 0.2 ± 0.2 | 0.2 ± 0.2 | 0.2 ± 0.2 |
| eGFR, mL/min/1.73 m2 ± SD | 114.5 ± 19.8 | 113.2 ± 22.6 | 113.9 ± 21.1 |
| Documented hypoglycemia (SMBG <70 mg/dL), events/patient per day ± SDa | 0.3 ± 0.4 | 0.1 ± 0.2 | 0.2 ± 0.3 |
a
The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week before a visit.
BHB, β-hydroxybutyrate; BMI, body mass index; CSII, continuous subcutaneous insulin infusion; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; MDI, multiple daily insulin injections; PPG, postprandial glucose; SD, standard deviation; SMBG, self-monitored blood glucose; T1D, type 1 diabetes.