Table 3

AEs

Placebo add-on to saxagliptin plus metformin (n = 160)Dapagliflozin add-on to saxagliptin plus metformin (n = 160)
At least 1 AE94 (58.8)90 (56.3)
At least 1 SAE3 (1.9)5 (3.1)
AE leading to discontinuation2 (1.3)8 (5.0)
SAE leading to discontinuation2 (1.3)3 (1.9)
Most common AEs (≥5% of patients)
 Headache9 (5.6)9 (5.6)
 Influenza8 (5.0)8 (5.0)
 Diarrhea8 (5.0)3 (1.9)
AEs of special interest
 Urinary tract infections10 (6.3)8 (5.0)
 Genital infections1 (0.6)8 (5.0)
 GFR decrease02 (1.3)
 Fractures2 (1.3)0
 Decreased thrombocyte count1 (0.6)2 (1.3)
 Breast neoplasms01 (0.6)
 Heart failure02 (1.3)
 Hypoglycemia*02 (1.3)
  Major00
  Minor00
  Other02 (1.3)
 Adjudicated cardiovascular events02 (1.3)
 Adjudicated liver AEs3 (1.9)1 (0.6)
  • Data are n (%). GFR, glomerular filtration rate. *Hypoglycemia includes minor (symptomatic or asymptomatic with plasma glucose concentration <63 mg/dL, regardless of need for external assistance), major (symptomatic requiring third-party assistance due to severe impairment in consciousness or behavior with 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) episodes. Data after the receipt of rescue medication were excluded; one patient receiving placebo reported a minor hypoglycemia episode while receiving glimepiride rescue medication.