Table 2

Overall summary of patients with an AE and AEs of special interest

Insulin plus placebo
(N = 13)Insulin plus dapagliflozin
1 mg
(N = 13)2.5 mg
(N = 15)5 mg
(N = 14)10 mg
(N = 15)
Overall summary of patients with an AE
 ≥1 AE*8 (61.5)5 (38.5)7 (46.7)7 (50.0)6 (40.0)
  ≥1 AE related to study treatment02 (15.4)2 (13.3)2 (14.3)0
  AE leading to study discontinuation0001 (7.1)0
 ≥1 SAE0001 (7.1)0
  ≥1 SAE related to study treatment00000
  SAE leading to study discontinuation0001 (7.1)0
AEs of special interest
 Hypoglycemic events§
  Total events, n3976315423
  Total patients with ≥1 AEs8 (61.5)12 (92.3)9 (60.0)11 (78.6)10 (66.7)
   Major episode00001 (6.7)‖
   Minor episode8 (61.5)12 (92.3)7 (46.7)10 (71.4)7 (46.7)
    ≤3 AEs5 (38.5)7 (53.8)5 (33.3)6 (42.9)6 (40.0)
    4–6 events2 (15.4)2 (15.4)2 (13.3)2 (14.3)1 (6.7)
    ≥7 events1 (7.7)3 (23.1)02 (14.3)0
   Other episode5 (38.5)7 (53.8)4 (26.7)9 (64.3)6 (40.0)
    ≤3 events4 (30.8)4 (30.8)3 (20.0)9 (64.3)6 (40.0)
    4–6 events1 (7.7)3 (23.1)000
    ≥7 events001 (6.7)00
   Discontinuation due to hypoglycemia00001 (6.7)
  Events of genital infection or of UTI
  Vulvovaginal mycotic infection0001 (7.1)0
  Vaginal infection01 (7.7)000
  UTI1 (7.7)01 (6.7)00
  • Data are reported as n (%), unless otherwise stated.

  • N is the number of patients exposed to study medications.

  • SAE, serious AE; UTI, urinary tract infection.

  • * Counted up to 4 days after last dose date.

  • Data represent a single patient with gastroparesis on day 10, who discontinued the study.

  • Counted up to 30 days after last dose date.

  • § Hypoglycemic events were collected separately from general AEs. If hypoglycemic events qualified as SAEs, these events were to be collected and summarized with all other SAEs. Otherwise, hypoglycemic events were collected and summarized separately up to 4 days after the date of the last dose. Major hypoglycemia was defined as a symptomatic episode requiring external (third-party) assistance due to severe impairment in consciousness or behavior with capillary or plasma glucose values of <3.0 mmol/L (<54 mg/dL) and prompt recovery after glucose or glucagon administration. Minor hypoglycemia was defined as either a symptomatic episode with a capillary or plasma glucose value of <3.5 mmol/L (<63 mg/dL), regardless of the need for external assistance; or an asymptomatic capillary or plasma glucose value of <3.5 mmol/L (<63 mg/dL) that did not qualify as a major episode. Other hypoglycemia was defined as a suggestive episode reported but not meeting the criteria for major or minor episodes.

  • One patient was listed as having discontinued study participation due to hypoglycemia. The patient experienced a major hypoglycemia episode on day 6 while receiving dapagliflozin 10 mg plus insulin, which the investigator felt to be related to a failure of the patient to reduce insulin as instructed. The patient was allowed to continue in the inpatient portion of the study, but the investigator expressed concerns regarding the compliance of this patient as an outpatient, and so the patient had study participation discontinued on day 8.

  • A prespecified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA version 15.1) was used to identify events of genital infection and of UTI in the database.