Table 3

Adverse events

PlaceboPrimary cohortExploratory cohorts
Dapagliflozin morning doseDapagliflozin evening doseDapagliflozin morning dose (A1C ≥10.1)#
2.5 mg5 mg10 mg2.5 mg5 mg10 mg5 mg10 mg
n756564706768763439
AEs
At least one AE45 (60.0)41 (63.1)37 (57.8)48 (68.6)45 (67.2)44 (64.7)45 (59.2)27 (79.4)28 (71.8)
At least one serious AE3 (4.0)01 (1.6)1 (1.4)1 (1.5)1 (1.5)1 (1.3)00
Discontinuation for AE1 (1.3)2 (3.1)3 (4.7)5 (7.1)04 (5.9)3 (3.9)00
Discontinuation for serious AE001 (1.6)001 (1.5)1 (1.3)00
Most common AEs (≥10% in any group) by MedDRA preferred term*
    Nasopharyngitis4 (5.3)7 (10.8)3 (4.7)2 (2.9)7 (10.4)5 (7.4)4 (5.3)4 (11.8)4 (10.3)
    Diarrhea1 (1.3)4 (6.2)1 (1.6)1 (1.4)3 (4.5)7 (10.3)3 (3.9)2 (5.9)1 (2.6)
    Headache5 (6.7)5 (7.7)3 (4.7)4 (5.7)3 (4.5)9 (13.2)9 (11.8)5 (14.7)6 (15.4)
Events by special interest category
    Hypoglycemia2 (2.7)1 (1.5)02 (2.9)1 (1.5)01 (1.3)1 (2.9)0
    Events suggestive of UTIs3 (4.0)3 (4.6)8 (12.5)4 (5.7)5 (7.5)8 (11.8)5 (6.6)3 (8.8)6 (15.4)
    Events suggestive of genital infections§1 (1.3)5 (7.7)5 (7.8)9 (12.9)6 (9.0)3 (4.4)2 (2.6)2 (5.9)7 (17.9)
    Hypotensive events1 (1.3)001 (1.4)3 (4.5)001 (2.9)1 (2.6)
  • Data are n (%) and include data after rescue.

  • *Additional adverse events (AEs) with ≥5% incidence in any of the primary cohort and exploratory evening dose arms were arthralgia, pharyngitis, upper respiratory infection, UTI, back pain, dizziness, constipation, influenza, myalgia, peripheral edema, pain in extremity, and insomnia.

  • †None of the hypoglycemic events led to discontinuation from the study, and none was a major episode, defined as a symptomatic episode requiring third-party assistance due to severe impairment in consciousness or behavior, with a capillary or plasma glucose value <54 mg/dl, and prompt recovery after glucose or glucagon administration.

  • ‡These events included signs, symptoms, and other reports suggestive of UTIs.

  • §These events included signs, symptoms, and other reports suggestive of genital infections.

  • #Not placebo controlled.