Table 2

Safety: AEs and SAEs

Liraglutide 1.8 mgLiraglutide 1.2 mgLiraglutide 0.6 mgPlacebo
N%RN%RN%RN%R
Participants, N347348350348
Exposure years278.9286.3315.5296.6
AEs31390.27.730286.86.029885.15.327579.04.8
SAEs298.40.143610.30.173510.00.153810.90.18
Leading to premature treatment discontinuation5114.70.304412.60.29174.90.08123.40.06
Hypoglycemic episodes
 All32994.850.232292.549.433495.445.432192.242.7
 Symptomatic*29083.616.528581.916.127779.115.727679.312.3
 Severe or BG confirmed**30688.221.130086.220.029484.019.229083.316.9
 ADA classification32994.850.132292.549.333395.145.432192.242.6
  Severe288.10.17226.30.11329.10.133710.60.19
  Documented symptomatic30989.034.430387.134.031188.932.630286.827.7
  Asymptomatic29585.015.227278.214.827678.912.227879.914.0
  Probable symptomatic4011.50.30318.90.283911.10.344011.50.39
  Pseudo-hypoglycemia185.20.08216.00.12205.70.11226.30.35
Hyperglycemic episodes
 All30788.533.529384.230.930988.329.531289.734.7
 Episodes with ketosis***3911.20.28267.50.15226.30.17246.90.12
Gastrointestinal disorders
 All23768.32.721260.91.917550.01.311633.30.76
 Nausea17249.60.9714240.80.6911232.00.474212.10.18
EAC-confirmed SAEsNEventsNEventsNEventsNEvents
Neoplasms****99336644
 Benign77336633
 Malignant22000011
Pancreatitis00001100
Cardiovascular disease
 ACS events00111111
 Stroke00000000
 Transient ischemic attack00110000
EAC-confirmed severe hypoglycemia2845223132403857
EAC-confirmed DKA33113400
  • 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).