Table 3.
Summary of adverse events (AEs) (SS)
| Adverse events (AEs) | Exenatide (N = 52) | Biphasic insulin aspart 30 (N = 52) | P value | ||
|---|---|---|---|---|---|
| Events, n | Patients, n (%) | Events, n | Patients, n (%) | ||
| All AEs | 114 | 37 (71.15) | 105 | 36 (69.23) | 1 |
| Study drug-related AEsa | 71 | 27 (51.92) | 56 | 25 (48.08) | 0.8446 |
| AEs unrelated to the study drug | 43 | 23 (44.23) | 49 | 25 (48/08) | 0.8442 |
| Severe AEs | 5 | 4 (7.69) | 5 | 3 (5.77) | 1 |
| Study drug-related AEsa | |||||
| Dysglycemiab/hypoglycemia | 20/17 | 13 (25.00)/10 (19.23) | 45/45 | 19 (36.54)/19 (36.54) | 0.2881 |
| Headache/dizziness | 5 | 5 (9.62) | 1 | 1 (1.92) | 0.205 |
| Abdominal discomfort | 3 | 3 (5.77) | 0 | 0 (0.00) | 0.2427 |
| Dyslipidemia | 3 | 3 (5.77) | 2 | 2 (3.85) | 1 |
| Decreased appetite | 3 | 2 (3.85) | 0 | 0 (0.00) | 0.4951 |
| Upper respiratory tract | 2 | 2 (3.85) | 0 | 0 (0.00) | 0.4951 |
| Infection | |||||
| Constipation | 2 | 1 (1.92) | 0 | 0 (0.00) | 1 |
| Allergic reactions to the drug | 2 | 1 (1.92) | 0 | 0 (0.00) | 1 |
| Cardiac abnormalities | 1 | 1 (1.92) | 0 | 0 (0.00) | 1 |
| Lack of attention/concentration | 1 | 1 (1.92) | 0 | 0 (0.00) | 1 |
| Hip joint pain | 1 | 1 (1.92) | 0 | 0 (0.00) | 1 |
| Abnormal liver function test results | 0 | 0 (0.00) | 2 | 1 (1.92) | 1 |
| Urinary tract infection | 0 | 0 (0.00) | 2 | 1 (1.92) | 1 |
| Abnormal hs-CRP level | 0 | 0 (0.00) | 1 | 1 (1.92) | 1 |
| Skin allergies | 0 | 0 (0.00) | 1 | 1 (1.92) | 1 |
| Upper/lower extremity pain | 0 | 0 (0.00) | 1 | 1 (1.92) | 1 |
| Left heel pain | 0 | 0 (0.00) | 1 | 1 (1.92) | 1 |
Data were presented as n (%) in patients who received ≥ 1 dose of study drug and had baseline safety data and also safety data for at least 1 follow-up visit
SS safety set, hs-CRP high sensitivity C-reactive protein
aStudy drug-related AEs referred to AEs definitely or possibly related to the study drug or AEs possibly unrelated to the study drug
bDysglycemia included hypoglycemia and other forms of dysglycemia