Table 3

AEs

AEsPlacebo add-on to dapagliflozin plus metformin (n = 162)Saxagliptin add-on to dapagliflozin plus metformin (n = 153)
At least 1 AE70 (43.2)73 (47.7)
At least 1 SAE5 (3.1)5 (3.3)
AE leading to discontinuation3 (1.9)1 (0.7)
SAE leading to discontinuation0 (0)0 (0)
AEs of special interest
 Urinary tract infection6 (3.7)8 (5.2)
 Genital infection4 (2.5)0 (0)
 GFR decrease2 (1.2)0 (0)
 Fracture1 (0.6)1 (0.7)
 Heart failure2 (1.2)1 (0.7)
 Severe cutaneous1 (0.6)0 (0)
 Hypersensitivity2 (1.2)0 (0)
 Hypotension, dehydration, hypovolemia2 (1.2)0 (0)
Hypoglycemia*4 (2.5)2 (1.3)
 Major0 (0)0 (0)
 Minor2 (1.2)1 (0.7)
 Other3 (1.9)1 (0.7)
Adjudicated cardiovascular event1 (0.6)1 (0.7)
Adjudicated liver AE2 (1.2)2 (1.3)
  • Data are n (%). GFR, glomerular filtration rate; SAE, serious AE.

  • *Hypoglycemic episodes were classified as minor (symptomatic or asymptomatic with plasma glucose concentration <63 mg/dL, regardless of need for external assistance); major (symptomatic requiring third-party assistance owing to severe impairment in consciousness or behavior, with or without plasma glucose concentration <54 mg/dL and prompt recovery after glucose or glucagon administration); and other (suggestive episode not meeting the criteria for major or minor).