Safety of IDegLira and iGlarLixi in Phase 3 Trials
| Population | Patients With Type 2 Diabetes Uncontrolled on Basal Insulin | Patients With Type 2 Diabetes Uncontrolled on a GLP-1 Receptor Agonist | ||||||
|---|---|---|---|---|---|---|---|---|
| Trial | DUAL II (47) | DUAL V (48) | LixiLan-L(50) | DUAL III (49) | ||||
| Treatment | IDegLira | Insulin degludec | IDegLira | Insulin glargine U100 | iGlarLixi | Insulin glargine U100 | IDegLira | Unchanged GLP-1 Receptor Agonist |
| n | 199 | 199 | 278 | 279 | 365 | 365 | 292 | 146 |
| Hypoglycemia (% [events/PYE]) | ||||||||
| Overall | 24.1 (1.5) | 24.6 (2.6) | 28.4 (2.23)* | 49.1 (5.05) | 40.0 (3.03) | 42.5 (4.22) | 32 (2.82) | 2.8 (0.12)† |
| Nocturnal | 6.0 (0.22) | 8.5 (0.32) | 6.1 (0.22)* | 24.4 (1.23) | NR | NR | 11 (0.454) | 0.7 (0.015)† |
| Severe | n = 1‡ | n = 0‡ | n = 0‡ | n = 1‡ | 1.1 (0.02) | 0.3 (<0.01) | 0.3 (0.007) | 0 (0) |
| Body weight (kg) | ||||||||
| Baseline (SD) | 95.4 (19) | 93.5 (20) | 88.3 (17.5) | 87.3 (15.8) | 87.7 (14.5) | 87.1 (14.8) | 95.6 (16.6) | 95.5 (17.3) |
| End of trial (SD) | NR | NR | 86.9 (17.2) | 89.1 (15.9) | 87.5 (14.4) | 88.0 (15.1) | NR | NR |
| Change (SD) | –2.7 (NR)* | 0.0 (NR) | –1.4 (3.5)* | 1.8 (3.6) | –0.7 (SE 0.2)* | 0.7 (SE 0.2) | 2.0 (3.9) | –0.8 (3.0)† |
| Adverse event (% [events/PYE]) | 57.8 (4.0) | 61.3 (3.6) | 57.6 (3.43) | 50.5 (2.86) | 53.4 (NR) | 52.3 (NR) | 65.6 (4.10) | 63.4 (3.64) |
| Serious adverse event (% [events/PYE]) | 3.5 (0.12) | 5.5 (0.14) | 1.8 (0.04) | 3.2 (0.07) | 5.5 (NR) | 4.9 (NR) | 3.1 (0.09) | 2.1 (0.05) |
| Nausea (% [events/PYE]) | 6.5 (0.22) | 3.5 (0.08) | 9.4 (0.26) | 1.1 (0.02) | 10.4 (NR) | 0.5 (NR) | 3.1 (0.08) | 4.1 (0.11) |
| MACE (n) | 1 | 2 | 1 | 1 | similar % | similar % | 2 | 0 |
| Pancreatitis (n) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pancreatic carcinoma (n) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Medullary thyroid carcinoma/thyroid neoplasm (n) | 0 | 0 | 0 | 0 | NR | NR | 0 | 0 |