Table 2

Summary of AEs in the ITT population (n =121)

Exenatide QW 2 mg (n = 30)Exenatide QMS 5 mg (n = 30)Exenatide QMS 8 mg (n = 31)Exenatide QMS 11 mg (n = 30)
AEs27 (90.0)25 (83.3)20 (64.5)24 (80.0)
Serious AEs0 (0.0)2 (6.7)0 (0.0)0 (0.0)
AEs leading to withdrawal0 (0.0)0 (0.0)0 (0.0)1 (3.3)
Any gastrointestinal-related AE11 (36.7)10 (33.3)10 (32.3)18 (60.0)
Injection-site nodules*25 (83.3)21 (80.8)23 (79.3)25 (89.3)
AEs occurring in ≥5% of patients
 Headache9 (30.0)5 (16.7)7 (22.6)8 (26.7)
 Nausea4 (13.3)5 (16.7)7 (22.6)7 (23.3)
 Diarrhea8 (26.7)2 (6.7)4 (12.9)5 (16.7)
 Vomiting3 (10.0)2 (6.7)4 (12.9)5 (16.7)
 Dyspepsia3 (10.0)1 (3.3)5 (16.1)3 (10.0)
 Decreased appetite4 (13.3)1 (3.3)3 (9.7)6 (20.0)
 Increased appetite2 (6.7)1 (3.3)1 (3.2)1 (3.3)
 Eructation0 (0.0)2 (6.7)4 (12.9)4 (13.3)
 Abdominal distension0 (0.0)1 (3.3)1 (3.2)3 (10.0)
 Abdominal pain0 (0.0)1 (3.3)0 (0.0)2 (6.7)
 Constipation1 (3.3)1 (3.3)0 (0.0)2 (6.7)
 Flatulence1 (3.3)1 (3.3)3 (9.7)1 (3.3)
 Injection-site
  Pruritus5 (16.7)4 (13.3)1 (3.2)2 (6.7)
  Erythema4 (13.3)2 (6.7)1 (3.2)2 (6.7)
  Hematoma2 (6.7)0 (0.0)0 (0.0)1 (3.3)
  Hemorrhage0 (0.0)1 (3.3)1 (3.2)2 (6.7)
  Pain1 (3.3)1 (3.3)0 (0.0)2 (6.7)
 Pain2 (6.7)0 (0.0)0 (0.0)0 (0.0)
 Arthralgia2 (6.7)1 (3.3)0 (0.0)1 (3.3)
 Back pain2 (6.7)1 (3.3)0 (0.0)2 (6.7)
 Muscle spasms0 (0.0)1 (3.3)2 (6.5)0 (0.0)
 Nasal congestion4 (13.3)0 (0.0)3 (9.7)1 (3.3)
 Fatigue1 (3.3)1 (3.3)3 (9.7)3 (10.0)
 Anxiety0 (0.0)2 (6.7)1 (3.2)2 (6.7)
 Upper respiratory tract infection1 (3.3)4 (13.3)1 (3.2)1 (3.3)
 Cough3 (10.0)3 (10.0)0 (0.0)0 (0.0)
 Dyspnea0 (0.0)2 (6.7)0 (0.0)0 (0.0)
 Respiratory tract congestion1 (3.3)2 (6.7)0 (0.0)0 (0.0)
 Sinusitis2 (6.7)1 (3.3)1 (3.2)0 (0.0)
 Gastroenteritis2 (6.7)1 (3.3)1 (3.2)2 (6.7)
 Dysmenorrhea1 (10.0)1 (7.7)0 (0.0)0 (0.0)
 Rash2 (6.7)0 (0.0)0 (0.0)0 (0.0)
 Diabetes inadequate control3 (10.0)0 (0.0)2 (6.5)0 (0.0)
  • Data are n (%).

  • *Data on injection-site nodules were solicited from patients with a survey.

  • †Proportion of female patients only.