Table 1

Summary of overall safety and selected AEs

Patients, n (%)
GLIM (n = 482)CANA 100 mg (n = 483)CANA 300 mg (n = 485)
Any AE378 (78.4)354 (73.3)378 (77.9)
AEs leading to discontinuation35 (7.3)30 (6.2)46 (9.5)
AEs related to study drug*134 (27.8)138 (28.6)159 (32.8)
Serious AEs69 (14.3)47 (9.7)47 (9.7)
Deaths2 (0.4)3 (0.6)3 (0.6)§
Genital mycotic infection
 Male,5 (1.9)24 (9.5)22 (9.1)
 Female#,**6 (2.7)32 (13.9)38 (15.6)
UTIs33 (6.8)51 (10.6)42 (8.7)
Osmotic diuresis–related AEs††10 (2.1)28 (5.8)32 (6.6)
Volume depletion AEs‡‡11 (2.3)8 (1.7)12 (2.5)
  • All AEs are reported for regardless of rescue medication.

  • CANA, canagliflozin; GLIM, glimepiride.

  • * Possibly, probably, or very likely related to study drug, as assessed by investigators.

  • One patient died due to squamous cell carcinoma of the cervix, and one patient died due to unwitnessed cardiac arrest.

  • One patient died due to acute chemical poisoning, one patient died due to intracranial hemorrhage, and one patient died due to pulmonary embolism and acute renal failure.

  • § One patient died due to anemia, one patient died due to a road traffic accident, and one patient died due to trauma from a fall from the roof.

  • GLIM, n = 263; CANA 100 mg, n = 252; CANA 300 mg, n = 241.

  • Including balanitis, balanitis candida, balanoposthitis, genital candidiasis, genital infection fungal, and posthitis.

  • # GLIM, n = 219; CANA 100 mg, n = 231; CANA 300 mg, n = 244.

  • ** Including genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

  • †† Including dry mouth, micturition urgency, nocturia, pollakiuria, polydipsia, polyuria, thirst, and urine output increased.

  • ‡‡ Including BP decreased, dehydration, postural dizziness, hypotension, orthostatic hypotension, presyncope, and syncope.