Table 3.
Treatment-Emergent Adverse Events
| Insulin glargine or insulin glargine plus insulin glulisine (n = 6305) | Insulin glulisine (n = 176) | All patients (n = 6481) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Events | Patients | Events | Patients | Events | Patients | ||||
| n | % | n | % | n | % | ||||
| All | 352 | 191 | 3.03 | 1 | 1 | 0.57 | 353 | 192 | 2.96 |
| Metabolism and nutrition disorders | 250 | 116 | 1.84 | 250 | 116 | 1.79 | |||
| Infections and infestations | 21 | 20 | 0.32 | 1 | 1 | 0.57 | 22 | 21 | 0.32 |
| General disorders and administration site conditions | 20 | 19 | 0.3 | 20 | 19 | 0.29 | |||
| Nervous system disorders | 9 | 9 | 0.14 | 9 | 9 | 0.14 | |||
| Cardiac disorders | 9 | 8 | 0.13 | 9 | 8 | 0.12 | |||
| Injury, poisoning, and procedural complications | 8 | 8 | 0.13 | 8 | 8 | 0.12 | |||
| Skin and subcutaneous tissue disorders | 7 | 7 | 0.11 | 7 | 7 | 0.11 | |||
| Musculoskeletal and connective tissue disorders | 6 | 6 | 0.1 | 6 | 6 | 0.09 | |||
| Gastrointestinal disorders | 6 | 5 | 0.08 | 6 | 5 | 0.08 | |||
| Respiratory, thoracic, and mediastinal disorders | 4 | 4 | 0.06 | 4 | 4 | 0.06 | |||
| Vascular disorders | 5 | 4 | 0.06 | 5 | 4 | 0.06 | |||
| Surgical and medical procedures | 2 | 2 | 0.03 | 2 | 2 | 0.03 | |||