Table 3

Summary of overall safety and selected AEs over 26 weeks

Patients, n (%)CANA100/MET (n = 237)CANA300/MET (n = 237)CANA100 (n = 237)CANA300 (n = 238)MET (n = 237)
Any AE99 (41.8)105 (44.3)88 (37.1)95 (39.9)89 (37.6)
AEs leading to discontinuation4 (1.7)7 (3.0)3 (1.3)7 (2.9)4 (1.7)
AEs related to the study drug*15 (6.3)35 (14.8)24 (10.1)22 (9.2)17 (7.2)
Serious AEs7 (3.0)4 (1.7)4 (1.7)7 (2.9)7 (3.0)
Deaths00001 (0.4)
UTIs3 (1.3)7 (3.0)3 (1.3)5 (2.1)3 (1.3)
Genital mycotic infections
 Male1 (0.9)2 (1.7)2 (1.9)5 (4.0)0
 Female§3 (2.3)4 (3.3)3 (2.3)5 (4.4)0
Osmotic diuresis–related AEs2 (0.8)6 (2.5)5 (2.1)4 (1.7)2 (0.8)
Volume depletion–related AEs#4 (1.7)2 (0.8)1 (0.4)3 (1.3)1 (0.4)
Renal-related AEs**1 (0.4)3 (1.3)7 (3.0)3 (1.3)0
Gastrointestinal-related AEs††11 (4.6)11 (4.6)4 (1.7)7 (2.9)10 (4.2)
Hypoglycemia episodes
 Documented hypoglycemia‡‡10 (4.2)13 (5.5)7 (3.0)9 (3.8)11 (4.6)
 Severe hypoglycemia00001 (0.4)
  • *Possibly, probably, or very likely related to study drug, as assessed by investigators.

  • †CANA100/MET, n = 108; CANA300/MET, n = 115; CANA100, n = 105; CANA300, n = 125; MET, n = 116.

  • ‡Includes balanoposthitis, genital candidiasis, and genital fungal infection.

  • §CANA100/MET, n = 129; CANA300/MET, n = 122; CANA100, n = 132; CANA300, n = 113; MET, n = 121.

  • ‖Includes genital infection female, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis.

  • ¶Includes dry mouth, pollakiuria, polyuria, and thirst.

  • #Includes dehydration, dizziness postural, hypotension, orthostatic hypotension, and syncope.

  • **Includes blood creatinine increased, glomerular filtration rate decreased, and renal impairment.

  • ††Includes diarrhea, nausea, and vomiting.

  • ‡‡Includes biochemically documented episodes (fingerstick or plasma glucose ≤70 mg/dL [≤3.9 mmol/L]), with or without symptoms, and severe episodes (i.e., requiring the assistance of another individual or resulting in seizure, loss of consciousness, or cognitive dysfunction).