Table 2

Treatment-emergent hypoglycemia episodes over 18 weeks

Placebo Canagliflozin
(n = 117)100 mg (n = 117)300 mg (n = 117)
Patients with any
 Documented hypoglycemia, n (%)*113 (96.6)115 (98.3)116 (99.1)
  Event rate per patient-year of exposure (95% CI)80.6 (77.8, 83.4)70.7 (68.1, 73.3)79.2 (76.4, 82.0)
 Documented symptomatic hypoglycemia, n (%)109 (93.2)112 (95.7)111 (94.9)
  Event rate per patient-year of exposure (95% CI)56.1 (53.8, 58.4)50.6 (48.4, 52.8)47.3 (45.2, 49.5)
 Severe hypoglycemia, n (%)2 (1.7)3 (2.6)8 (6.8)
  • *Concurrent fingerstick or plasma glucose ≤3.9 mmol/L (≤70 mg/dL) or a severe hypoglycemic episode.

  • †Symptoms consistent with hypoglycemia with concurrent biochemically documented plasma glucose ≤3.9 mmol/L (≤70 mg/dL) or a severe hypoglycemic episode.

  • ‡Requiring assistance from another person or those resulting in seizure or loss of consciousness.