Table 3.
Positively adjudicated DKA by selected subgroups
| EAIR positively adjudicated DKA events per 100 patient-years (95% CI) | |||
|---|---|---|---|
| Placebo (n = 526) | Sotagliflozin 200 mg (n = 524) | Sotagliflozin 400 mg (n = 525) | |
| CSII | 0.5 (0.0, 0.6) | 4.4 (1.5, 7.3) | 6.0 (2.6, 9.3) |
| Total patients | n = 226 | n = 224 | n = 224 |
| MDI | 0 | 2.2 (0.4, 3.9) | 2.9 (0.9, 4.9) |
| Total patients | n = 300 | n = 300 | n = 301 |
| BMI <27 kg/m2 | 0 | 3.5 (0.9, 6.1) | 4.9 (1.7, 8.0) |
| Total patients | n = 228 | n = 219 | n = 212 |
| BMI ≥27 kg/m2 | 0.4 (0.0, 1.9) | 2.9 (0.8, 4.8) | 3.8 (1.5, 6.0) |
| Total patients | n = 298 | n = 305 | n = 313 |
| Male | 0.4 (0.0, 1.2) | 2.9 (0.7, 5.0) | 2.1 (0.3, 4.0) |
| Total patients | n = 271 | n = 265 | n = 253 |
| Female | 0 | 3.4 (1.0, 5.7) | 6.2 (3.1, 9.3) |
| Total patients | n = 255 | n = 259 | n = 272 |
| Baseline insulin dose <0.7 IU/kg | 0 | 3.3 (1.1, 5.5) | 4.4 (1.8, 6.9) |
| Total patients | n = 275 | n = 303 | n = 279 |
| Baseline insulin dose ≥0.7 IU/kg | 0.4 (0.0, 1.3) | 2.9 (0.6, 5.2) | 4.0 (1.4, 6.6) |
| Total patients | n = 251 | n = 221 | n = 244 |
MDI, multiple daily injection.