Table 3.
Adverse events
| Placebo (n = 229) |
Empagliflozin 10 mg (n = 224) |
Empagliflozin 25 mg (n = 223) |
Sitagliptin 100 mg (n = 223) |
|
|---|---|---|---|---|
| Any adverse event n (%) | 175 (76.4) | 172 (76.8) | 174 (78.0) | 161 (72.2) |
| Drug-relateda
adverse events n (%) |
36 (15.7) | 49 (21.9) | 52 (23.3) | 31 (13.9) |
| Discontinuation due to adverse events n (%) | 15 (6.6) | 11 (4.9) | 9 (4.0) | 11 (4.9) |
| Severe adverse events n (%) | 14 (6.1) | 17 (7.6) | 15 (6.7) | 17 (7.6) |
| Serious adverse events n (%) | 23 (10.0) | 25 (11.2) | 16 (7.2) | 18 (8.1) |
| Deaths | 1 (0.4) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
| Adverse events with frequency of ≥5 % in any group (by preferred term) n (%) | ||||
| Hyperglycaemia | 63 (27.5) | 20 (8.9) | 11 (4.9) | 28 (12.6) |
| Nasopharyngitis | 27 (11.8) | 32 (14.3) | 25 (11.2) | 27 (12.1) |
| Urinary tract infection | 21 (9.2) | 20 (8.9) | 14 (6.3) | 18 (8.1) |
| Upper respiratory tract infection | 12 (5.2) | 17 (7.6) | 16 (7.2) | 19 (8.5) |
| Dyslipidaemia | 15 (6.6) | 16 (7.1) | 14 (6.3) | 14 (6.3) |
| Back pain | 12 (5.2) | 7 (3.1) | 7 (3.1) | 19 (8.5) |
| Hypertension | 13 (5.7) | 11 (4.9) | 5 (2.2) | 14 (6.3) |
| Bronchitis | 10 (4.4) | 11 (4.9) | 6 (2.7) | 12 (5.4) |
| Diarrhoea | 9 (3.9) | 12 (5.4) | 6 (2.7) | 8 (3.6) |
| Special interest categories n (%) | ||||
| Confirmed hypoglycaemiab | 2 (0.9) | 2 (0.9) | 2 (0.9) | 2 (0.9) |
| Events requiring assistance | 0 (0.0) | 1 (0.4) | 0 (0.0) | 0 (0.0) |
| Events consistent with urinary tract infectionc | 25 (10.9) | 21 (9.4) | 20 (9.0) | 20 (9.0) |
| Male | 4 (3.2) | 4 (2.8) | 4 (2.8) | 6 (4.3) |
| Female | 21 (20.0) | 17 (20.7) | 16 (20.3) | 14 (17.1) |
| Events consistent with genital infectiond | 4 (1.7) | 13 (5.8) | 14 (6.3) | 2 (0.9) |
| Male | 2 (1.6) | 4 (2.8) | 4 (2.8) | 1 (0.7) |
| Female | 2 (1.9) | 9 (11.0) | 10 (12.7) | 1 (1.2) |
| Events consistent with volume depletione | 1 (0.4) | 6 (2.7) | 2 (0.9) | 3 (1.3) |
Data from the treated set
aAs reported by the investigator
bPlasma glucose ≤3.9 mmol/l and/or requiring assistance
cBased on 77 preferred terms
dBased on 89 preferred terms
eBased on eight preferred terms