Table 3

Summary of overall safety and selected AEs over 18 weeks

PlaceboCanagliflozin
(n = 117) 100 mg (n = 117)300 mg (n = 117)
Any AE64 (54.7)65 (55.6)79 (67.5)
AEs leading to discontinuation01 (0.9)2 (1.7)
AEs related to the study drug*15 (12.8)19 (16.2)34 (29.1)
Serious AEs09 (7.7)8 (6.8)
Deaths000
Urinary tract infections2 (1.7)5 (4.3)6 (5.1)
Genital mycotic infections
 Male000
 Female3 (5.6)2 (4.2)11 (21.2)
Osmotic diuresis–related AEs§3 (2.6)9 (7.7)11 (9.4)
Volume depletion–related AEs04 (3.4)1 (0.9)
Ketone-related AEs06 (5.1)11 (9.4)#
 Serious DKA AEs**05 (4.3)7 (6.0)
 Nonserious AEs††01 (0.9)5 (4.3)
  • Data are n (%). *Possibly, probably, or very likely related to study drug, as assessed by investigators.

  • †Placebo, n = 54; canagliflozin 100 mg, n = 48; canagliflozin 300 mg, n = 52.

  • ‡Including vaginal infection, vulvovaginal candidiasis, and vulvovaginal mycotic infection.

  • §Including dry mouth, nocturia, pollakiuria, polydipsia, polyuria, thirst, and urine output increased.

  • ‖Including dehydration, dizziness postural, hypotension, and syncope.

  • ¶Including DKA, ketoacidosis, and urine ketone body present.

  • #One patient had an initial serious DKA event and a subsequent nonserious DKA event of increased urine ketones.

  • **Requiring hospitalization.

  • ††Including increased urinary ketones and mild and moderate DKA or acidosis.