Overall summary of results
| Placebo (N = 17) | Sotagliflozin (N = 16) | P | |
|---|---|---|---|
| Efficacy | |||
| HbA1c change from baseline (%) | −0.06 | −0.55* | 0.002 |
| FPG change from baseline assessed at day 29 (mg/dL) | 39.0 | −18.6 | 0.15 |
| Daily bolus insulin change from baseline assessed at days 3–27 (%) | −6.4 | −32.0* | 0.007 |
| Daily basal insulin change from baseline assessed at days 3–27 (%) | 0.2 | −2.4 | 0.53 |
| Total daily insulin change from baseline assessed at days 3–27 (%) | −0.7 | −15.3* | 0.029 |
| Mean body weight change from baseline assessed at day 29 (kg) | 0.5 | −1.7* | 0.005 |
| Postmeal urinary glucose (g/3 h) at day 29† | 9.2 | 29.1 | 0.025 |
| Postmeal plasma glucose AUC (mg ⋅ h/dL over 3 h) at day 29† | 761 | 595 | 0.005 |
| PYY postmeal AUC change from baseline assessed at day 29 (pmol/L ⋅ h over 3 h) | −0.7 | 6.0* | 0.018 |
| Seated systolic blood pressure change from baseline assessed at day 29 (mmHg) | −3.9 | −4.9 | 0.45 |
| Safety | |||
| Patients with any TEAE (%) | 12 (71) | 14 (88) | N/A |
| Patients with SAE (both with DKA‡) | 0 | 2 | N/A |
| Hypoglycemic events (SMBG ≤70 mg/dL, baseline–day 36) | 354 | 304 | N/A |
| Documented symptomatic hypoglycemia (SMBG ≤70 mg/dL, baseline–day 36) | 185 | 162 | N/A |
| Asymptomatic hypoglycemia (SMBG ≤70 mg/dL, baseline–day 36) | 117 | 80 | N/A |
| SH | 0 | 0 | N/A |
| Hypoglycemia (SMBG ≤70 mg/dL, PPD) change from baseline at days 3–27 | −0.4* | −0.7* | 0.77 |
| Hypoglycemia (CGM ≥10 continuous min <70 mg/dL, PPD) change from baseline assessed at days 3–27 | −0.15 | −0.09 | 0.75 |
| Laboratory values associated with volume status | |||
| Serum sodium (mmol/L), change from baseline at day 29 (day 36) | −1.00 (−0.53) | −0.50 (1.50) | N/A |
| Serum creatinine (µmol/L), change from baseline at day 29 (day 36) | −0.53 (1.53) | 2.63 (0.63) | N/A |
| Serum BUN (mmol/L), change from baseline at day 29 (day 36) | 0.41 (0.11) | 1.02 (−0.41) | N/A |
| Hematocrit, change from baseline at day 29 (day 36) | −1.4 (0) | 2.1 (1.5) | N/A |
For laboratory values, change from baseline was assessed at day 29, the last day of therapy, and day 36, 1 week off therapy, unless otherwise specified. N/A, not applicable; SAE, serious adverse event.
↵*P < 0.05, change from baseline.
↵†Day 1 is not a true “baseline”; therefore, P values are calculated from two-sample t tests using the observed means.
↵‡Both were assessed as due to insulin pump and deemed not drug related. Bold values are statistically significant.