Table 2

Summary of hypoglycemia events (safety analysis set)*

Dapagliflozin 5 mg (n = 277)Dapagliflozin 10 mg (n = 296)Placebo (n = 260)
Hypoglycemia events, n7,1468,4517,670
Patients with ≥1 events, n (%)227 (81.9)241 (81.4)212 (81.5)
Exposure-adjusted incidence rate, per 100 patient-years2,834.673,099.873,300.58
Severe hypoglycemia
 Events, n465885
 Patients with ≥1 events, n (%)29 (10.5)25 (8.4)30 (11.5)
 Exposure-adjusted incidence rate, per 100 patient-years18.2521.2736.58
Documented symptomatic hypoglycemia
 Events, n5,7756,7446,010
 Patients with ≥1 events, n (%)215 (77.6)227 (76.7)198 (76.2)
 Exposure-adjusted incidence rate, per 100 patient-years2,290.822,473.732,586.24
Asymptomatic hypoglycemia
 Events, n1,0351,2931,279
 Patients with ≥1 events, n (%)110 (39.7)135 (45.6)104 (40.0)
 Exposure-adjusted incidence rate, per 100 patient-years410.56474.28550.38
Probable symptomatic hypoglycemia
 Events, n131149182
 Patients with ≥1 events, n (%)48 (17.3)47 (15.9)49 (18.8)
 Exposure-adjusted incidence rate, per 100 patient-years51.9654.6578.32
Relative hypoglycemia
 Events, n13317796
 Patients with ≥1 events, n (%)43 (15.5)40 (13.5)31 (11.9)
 Exposure-adjusted incidence rate, per 100 patient-years52.7664.9241.31
Other hypoglycemia
 Events, n263018
 Patients with ≥1 events, n (%)12 (4.3)14 (4.7)13 (5.0)
 Exposure-adjusted incidence rate, per 100 patient-years10.3111.007.75
  • *Includes events on or after day 1 of the treatment period up to and 30 days after the last dose date in the treatment period.