Table 3

Hypoglycemia and gastrointestinal adverse events by baseline body mass index (BMI) subgroup

BMI <25 kg/m2BMI 25–<30 kg/m2BMI ≥30 kg/m2
PBO
(n=79)
LIXI
(n=104)
Total
(n=183)
PBO
(n=142)
LIXI
(n=134)
Total
(n=276)
PBO
(n=42)
LIXI
(n=54)
Total
(n=96)
Severe hypoglycemia n (%)000000000
No of events (events/patient-year)000000000
Any symptomatic hypoglycemia n (%)8 (10.1)17 (16.4)25 (13.7)23 (16.2)19 (14.2)42 (15.2)2 (4.8)14 (25.9)16 (16.7)
No of events (events/patient-year)9 (0.20)28 (0.42)37 (0.33)45 (0.57)44 (0.54)89 (0.55)4 (0.15)30 (0.75)34 (0.51)
Symptomatic hypoglycemia with BG <3.3 mmol/L n (%)6 (7.6)12 (11.5)18 (9.8)16 (11.3)14 (10.5)30 (10.9)2 (4.8)8 (14.8)10 (10.4)
No of events (events/patient-year)7 (0.15)23 (0.34)30 (0.27)30 (0.38)37 (0.46)67 (0.42)3 (0.12)15 (0.37)18 (0.27)
Gastrointestinal adverse events, n (%)13 (16.5)42 (40.4)55 (30.1)18 (12.7)52 (38.8)70 (25.4)5 (11.9)20 (37.0)25 (26.0)
 Nausea4 (5.1)30 (28.9)34 (18.6)7 (4.9)36 (26.9)43 (15.6)4 (9.5)14 (25.9)18 (18.8)
 Vomiting2 (2.5)12 (11.5)14 (7.7)1 (0.7)11 (8.2)12 (4.4)07 (13.0)7 (7.3)
 Diarrhea3 (3.8)4 (3.9)7 (3.8)4 (2.8)6 (4.5)10 (3.6)01 (1.9)1 (1.0)
  • BG, blood glucose; LIXI, lixisenatide; PBO, placebo.