Table 2

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)39.0−18.60.15
 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 (%)0.2−2.40.53
 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 299.229.10.025
 Postmeal plasma glucose AUC (mg ⋅ h/dL over 3 h) at day 297615950.005
 PYY postmeal AUC change from baseline assessed at day 29 (pmol/L ⋅ h over 3 h)−0.76.0*0.018
 Seated systolic blood pressure change from baseline assessed at day 29 (mmHg)−3.9−4.90.45
Safety
 Patients with any TEAE (%)12 (71)14 (88)N/A
 Patients with SAE (both with DKA)02N/A
 Hypoglycemic events (SMBG ≤70 mg/dL, baseline–day 36)354304N/A
 Documented symptomatic hypoglycemia (SMBG ≤70 mg/dL, baseline–day 36)185162N/A
 Asymptomatic hypoglycemia (SMBG ≤70 mg/dL, baseline–day 36)11780N/A
 SH00N/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 3–27−0.15−0.090.75
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.