Safety: AEs and SAEs
| Liraglutide 1.8 mg | Liraglutide 1.2 mg | Liraglutide 0.6 mg | Placebo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | R | N | % | R | N | % | R | N | % | R | |
| Participants, N | 347 | 348 | 350 | 348 | ||||||||
| Exposure years | 278.9 | 286.3 | 315.5 | 296.6 | ||||||||
| AEs | 313 | 90.2 | 7.7 | 302 | 86.8 | 6.0 | 298 | 85.1 | 5.3 | 275 | 79.0 | 4.8 |
| SAEs | 29 | 8.4 | 0.14 | 36 | 10.3 | 0.17 | 35 | 10.0 | 0.15 | 38 | 10.9 | 0.18 |
| Leading to premature treatment discontinuation | 51 | 14.7 | 0.30 | 44 | 12.6 | 0.29 | 17 | 4.9 | 0.08 | 12 | 3.4 | 0.06 |
| Hypoglycemic episodes | ||||||||||||
| All | 329 | 94.8 | 50.2 | 322 | 92.5 | 49.4 | 334 | 95.4 | 45.4 | 321 | 92.2 | 42.7 |
| Symptomatic* | 290 | 83.6 | 16.5 | 285 | 81.9 | 16.1 | 277 | 79.1 | 15.7 | 276 | 79.3 | 12.3 |
| Severe or BG confirmed** | 306 | 88.2 | 21.1 | 300 | 86.2 | 20.0 | 294 | 84.0 | 19.2 | 290 | 83.3 | 16.9 |
| ADA classification | 329 | 94.8 | 50.1 | 322 | 92.5 | 49.3 | 333 | 95.1 | 45.4 | 321 | 92.2 | 42.6 |
| Severe | 28 | 8.1 | 0.17 | 22 | 6.3 | 0.11 | 32 | 9.1 | 0.13 | 37 | 10.6 | 0.19 |
| Documented symptomatic | 309 | 89.0 | 34.4 | 303 | 87.1 | 34.0 | 311 | 88.9 | 32.6 | 302 | 86.8 | 27.7 |
| Asymptomatic | 295 | 85.0 | 15.2 | 272 | 78.2 | 14.8 | 276 | 78.9 | 12.2 | 278 | 79.9 | 14.0 |
| Probable symptomatic | 40 | 11.5 | 0.30 | 31 | 8.9 | 0.28 | 39 | 11.1 | 0.34 | 40 | 11.5 | 0.39 |
| Pseudo-hypoglycemia | 18 | 5.2 | 0.08 | 21 | 6.0 | 0.12 | 20 | 5.7 | 0.11 | 22 | 6.3 | 0.35 |
| Hyperglycemic episodes | ||||||||||||
| All | 307 | 88.5 | 33.5 | 293 | 84.2 | 30.9 | 309 | 88.3 | 29.5 | 312 | 89.7 | 34.7 |
| Episodes with ketosis*** | 39 | 11.2 | 0.28 | 26 | 7.5 | 0.15 | 22 | 6.3 | 0.17 | 24 | 6.9 | 0.12 |
| Gastrointestinal disorders | ||||||||||||
| All | 237 | 68.3 | 2.7 | 212 | 60.9 | 1.9 | 175 | 50.0 | 1.3 | 116 | 33.3 | 0.76 |
| Nausea | 172 | 49.6 | 0.97 | 142 | 40.8 | 0.69 | 112 | 32.0 | 0.47 | 42 | 12.1 | 0.18 |
| EAC-confirmed SAEs | N | Events | N | Events | N | Events | N | Events | ||||
| Neoplasms**** | 9 | 9 | 3 | 3 | 6 | 6 | 4 | 4 | ||||
| Benign | 7 | 7 | 3 | 3 | 6 | 6 | 3 | 3 | ||||
| Malignant | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | ||||
| Pancreatitis | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | ||||
| Cardiovascular disease | ||||||||||||
| ACS events | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | ||||
| Stroke | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Transient ischemic attack | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | ||||
| EAC-confirmed severe hypoglycemia | 28 | 45 | 22 | 31 | 32 | 40 | 38 | 57 | ||||
| EAC-confirmed DKA | 3 | 3 | 1 | 1 | 3 | 4 | 0 | 0 | ||||
ACS, acute coronary syndrome; Events, number of events; N, number of participants experiencing at least one event; %, percentage of participants experiencing at least one event; R, event rate per year of exposure.
↵*Symptomatic hypoglycemia was defined as hypoglycemic episodes that are either severe according to ADA classification of hypoglycemia (13) or accompanied by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycemia.
↵**Severe or BG confirmed: hypoglycemic episodes that are either severe according to ADA classification of hypoglycemia (13) or an episode accompanied by a plasma BG value of <3.1 mmol/L (56 mg/dL); Novo Nordisk asymptomatic hypoglycemia is the difference between “severe or BG-confirmed” hypoglycemia and “symptomatic” hypoglycemia.
↵***Plasma ketone level >1.5 mmol/L.
↵****EAC-confirmed malignant neoplasms were all skin cancers (two malignant melanomas; one basal cell carcinoma) using ADA classification of hypoglycemia (13).