Table 2.
Summary of AEs (safety population)
| LixiLan (n = 161) | Gla-100 (n = 162) | |
|---|---|---|
| AEs* | n (%) | n (%) |
| Patients with documented symptomatic hypoglycemia† | 35 (21.7) | 37 (22.8) |
| Patients with any TEAE | 86 (53.4) | 82 (50.6) |
| Patients with serious TEAEs | 9 (5.6) | 6 (3.7) |
| Deaths | 0 (0.0) | 0 (0.0) |
| Patients with TEAEs leading to discontinuation | 6 (3.7) | 0 (0.0) |
| Nausea | 2 (1.2) | 0 (0.0) |
| Vomiting | 1 (0.6) | 0 (0.0) |
| Hypersensitivity‡ | 1 (0.6) | 0 (0.0) |
| Confusional state | 1 (0.6) | 0 (0.0) |
| Dizziness | 1 (0.6) | 0 (0.0) |
| Headache | 1 (0.6) | 0 (0.0) |
| Ovarian cancer | 1 (0.6) | 0 (0.0) |
| Gastrointestinal TEAEs | 25 (15.5) | 15 (9.3) |
| Nausea | 12 (7.5) | 0 (0.0) |
| Diarrhea | 5 (3.1) | 6 (3.7) |
| Vomiting | 4 (2.5) | 1 (0.6) |
| Constipation | 3 (1.9) | 0 (0.0) |
| Dyspepsia | 2 (1.2) | 1 (0.6) |
| Abdominal distension | 1 (0.6) | 2 (1.2) |
TEAE, treatment-emergent AE.
*AEs listed are TEAEs. More than one AE could be listed as a reason for discontinuation of an individual patient.
†Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤3.9 mmol/L (≤70 mg/dL).
‡Not positively adjudicated as an allergic reaction by an independent Allergic Reaction Assessment Committee.