Table 4.
Adverse events experienced by patients during the GetGoal-X study49 designed to assess the efficacy, safety, and tolerability of lixisenatide as compared with exenatide (unpublished data provided by Sanofi December 2012)
| Adverse events (n) | Lixisenatide 20 μg once daily n=318 | Exenatide 10 μg twice daily n=316 |
|---|---|---|
| Total | 69.5% (221) | 72.2% (228) |
| Serious | 2.8% (9) | 2.2% (7) |
| Leading to death | 0.3% (1) | 0.3% (1) |
| Leading to discontinuation | 10.4% (33) | 13% (41) |
| Gastrointestinal (All) | 43.1% (137) | 50.6% (160) |
| Nausea | 24.5% (78) | 35.1% (111) |
| Vomiting | 10.1% (32) | 13.3% (42) |
| Diarrhea | 10.4% (33) | 13.3% (42) |
| Patients with hypoglycemia | 2.5% (8) | 7.9% (25) |
| Hypoglycemic events | 2.5% (8) | 15.2% (48) |
| Severe hypoglycemia | 0% | 0% |