| |
Saxagliptin 2.5 mg (n=247) |
Saxagliptin 5 mg
(n=643) |
Placebo
(n=559) |
| Any AE, n (%) |
163 (66.0) |
341 (53.0) |
253 (45.3) |
| Any related AE* |
35 (14.2) |
62 (9.6) |
38 (6.8) |
| Any SAE |
12 (4.9) |
18 (2.8) |
9 (1.6) |
| Deaths |
1 (0.4) |
1 (0.2) |
0 |
| Any AE leading to discontinuation |
7 (2.8) |
7 (1.1) |
3 (0.5) |
| Any SAE leading to discontinuation |
3 (1.2) |
0 |
2 (0.4) |
| Most common AEs (≥3% in any group), n (%)† |
| Upper respiratory tract infection |
21 (8.5) |
39 (6.1) |
41 (7.3) |
| Urinary tract infection |
12 (4.9) |
27 (4.2) |
26 (4.7) |
| Nasopharyngitis |
12 (4.9) |
25 (3.9) |
17 (3.0) |
| Headache |
9 (3.6) |
22 (3.4) |
19 (3.4) |
| Diarrhea |
11 (4.5) |
16 (2.5) |
9 (1.6) |
| Dizziness |
3 (1.2) |
15 (2.3) |
17 (3.0) |
| Pain in extremity |
12 (4.9) |
13 (2.0) |
8 (1.4) |
| Cough |
9 (3.6) |
12 (1.9) |
14 (2.5) |
| Peripheral edema |
9 (3.6) |
8 (1.2) |
5 (0.9) |
| Sinusitis |
11 (4.5) |
8 (1.2) |
3 (0.5) |
| Dyspepsia |
8 (3.2) |
2 (0.3) |
1 (0.2) |
| Hypoglycemic events‡ |
10 (4.0) |
19 (3.0) |
9 (1.6) |
|
AE=adverse event; SAE=serious adverse event.
*Events considered by investigators to be related to study treatment.
†Presented in descending order by preferred term in the saxagliptin 5-mg group.
‡No events of confirmed hypoglycemia (symptoms of hypoglycemia and finger stick
glucose reading of ≤50 mg/dL) reported. |
| Table 2: Summary of Adverse Events. |
