Table 2.
Gastrointestinal adverse events in participants in the DUAL clinical trial program
| Previous treatment regimen | DUAL trial | Treatment group | Nausea (events per 100 PYE) | Diarrhea (events per 100 PYE) | Vomiting (events per 100 PYE) |
|---|---|---|---|---|---|
| OAD(s) | DUAL I | IDegLira | 20.9 | 23.5 | 10.1 |
| Degludec | 8.8 | 10.3 | 3.1 | ||
| Liraglutide | 54.3 | 39.8 | 23.6 | ||
| DUAL IV | IDegLira | 11.3 | 10.5 | 5.3 | |
| Placebo | 8.0 | 12.9 | 6.4 | ||
| DUAL VI | IDegLira 1WT | 13.1 | 4.9 | 3.3 | |
| IDegLira 2WT | 15.7 | 5.5 | 3.1 | ||
| DUAL VIII | IDegLira | 4.9 | 6.4 | 2.9 | |
| IGlar U100 | 1.4 | 2.2 | 1.7 | ||
| DUAL IX | IDegLira | 21.3 | 12.6 | 4.8 | |
| IGlar U100 | 1.9 | 7.6 | 3.8 | ||
| GLP-1RA | DUAL III | IDegLira | 7.8 | 12.8 | 2.8 |
| Pre-trial liraglutide or exenatide | 10.6 | 13.7 | 9.1 | ||
| Basal insulin | DUAL II | IDegLira | 21.8 | 22.8 | 9.8 |
| Degludec | 7.8 | 8.9 | NR | ||
| DUAL V | IDegLira | 26.2 | 17.7 | 17.0 | |
| IGlar U100 | 2.2 | 7.4 | 3.7 | ||
| DUAL VII | IDegLira | 30.7 | 19.9 | 10.0 | |
| IGlar U100 + IAsp (≤ 4 times) | 3.4 | 14.2 | 5.9 |
1WT once-weekly titration, 2WT twice-weekly titration, GLP-1RA glucagon-like peptide-1 receptor agonist, IAsp insulin aspart, IDegLira insulin degludec/liraglutide, IGlar insulin glargine, NR not reported, OAD oral antidiabetic therapy, PYE participant-year exposure