Table 3

Adverse and special interest events, double-blind treatment period for patients in the treatment cohort

Placebo + insulin10 mg dapagliflozin + insulin20 mg dapagliflozin + insulin
n232424
Overall adverse events*
    At least one adverse event15 (65.2)18 (75.0)16 (66.7)
    At least one serious adverse event1 (4.3)1 (4.2)
    Adverse event leading to discontinuation of study medication1 (4.3)§1 (4.2)1 (4.2)
Most common adverse events (frequency >5% in any treatment group)
    Nausea1 (4.3)1 (4.2)3 (12.5)
    Pollakiuria4 (17.4)2 (8.3)3 (12.5)
    Vomiting3 (12.5)
    Vulvovaginal mycotic infection3 (12.5)
    Anxiety2 (8.3)
    Back pain2 (8.7)3 (12.5)2 (8.3)
    Dry mouth2 (8.3)
    Nasopharyngitis2 (8.7)2 (8.3)2 (8.3)
    Edema, peripheral2 (8.3)
    Abdominal pain, upper2 (8.7)1 (4.2)
    Fatigue2 (8.3)1 (4.2)
    Influenza2 (8.7)1 (4.2)1 (4.2)
    Pain in extremity1 (4.3)2 (8.3)1 (4.2)
    Thirst1 (4.3)2 (8.3)1 (4.2)
    Upper respiratory tract infection2 (8.7)2 (8.3)1 (4.2)
    Headache2 (8.7)3 (12.5)
    Pharyngolaryngeal pain2 (8.3)
    Procedural pain2 (8.7)
Adverse events of special interest
    Urinary tract infection1 (4.2)
    Genital tract infection (total patients with an event)1 (4.3)5 (20.8)
    Vulvovaginal mycotic infection3 (12.5)
    Balanitis candida1 (4.2)
    Vaginal candidiasis1 (4.2)
    Genital infection, fungal1 (4.3)
Events of hypoglycemia
    Total patients with hypoglycemia3 (13.0)7 (29.2)6 (25.0)
        Major episode of hypoglycemia#1 (4.3)
Discontinuation due to lack of glycemic control
    Overall2 (8.7)1 (4.2)
    Before up-titration of insulin1 (4.3)
    On or after day of up-titration of insulin1 (4.3)1 (4.2)
  • Data are n (%).

  • *Events of hypoglycemia were evaluated separately from adverse events.

  • †Loss of consciousness.

  • ‡Noncardiac chest pain.

  • §Blood creatine phosphokinase increased

  • ‖Renal failure. Other adverse events reported when patient was “discontinued” included increased blood creatinine, increased blood urea, dehydration, and dizziness

  • ¶Microalbuminuria.

  • #Major hypoglycemic episode defined as 1) plasma blood glucose value <54 mg/dl, 2) at least one of the following symptoms: confusion/disorientation, abnormal behavior, or unconsciousness, and 3) external treatment provided.