Table 1

AEs occurring during the controlled treatment period (weeks 0–28) and extension phase (weeks 28–52)

Exenatide two times per day→QWS-AIExenatide QWS-AI
0–28 weeks
(n=146)
28–52 weeks
(n=116)
0–28 weeks
(n=229)
28–52 weeks
(n=193)
All patients with AEs108 (74.0)64 (55.2)162 (70.7)95 (49.2)
Patients with serious AEs7 (4.8)6 (5.2)6 (2.6)7 (3.6)
Patients with AEs leading to withdrawal11 (7.5)2 (1.7)11 (4.8)2 (1.0)
Patients with AEs leading to death01 (0.9)00
AEs occurring in ≥5% of patients
 Nausea30 (20.5)5 (4.3)22 (9.6)1 (0.5)
 Injection site nodule1 (0.7)5 (4.3)29 (12.7)1 (0.5)
 Diarrhea17 (11.6)2 (1.7)12 (5.2)3 (1.6)
 Headache9 (6.2)013 (5.7)2 (1.0)
 Upper respiratory tract infection5 (3.4)3 (2.6)13 (5.7)2 (1.0)
 Vomiting9 (6.2)2 (1.7)8 (3.5)1 (0.5)
Hypoglycemia*
 With concomitant sulfonylurea use at screeningn=60n=50n=89n=74
  Major hypoglycemia0000
  Minor hypoglycemia11 (18.3)4 (8.0)22 (24.7)6 (8.1)
   Mild5 (8.3)4 (8.0)13 (14.6)5 (6.8)
   Moderate6 (10.0)09 (10.1)1 (1.4)
   Severe0000
  Symptoms of hypoglycemia15 (25.0)10 (20.0)24 (27.0)9 (12.2)
   Mild12 (20.0)9 (18.0)20 (22.5)7 (9.5)
   Moderate2 (3.3)1 (2.0)4 (4.5)2 (2.7)
   Severe1 (1.7)000
 Without concomitant sulfonylurea use at screeningn=86n=66n=140n=119
  Major hypoglycemia0000
  Minor hypoglycemia3 (3.5)3 (4.5)3 (2.1)2 (1.7)
   Mild1 (1.2)2 (3.0)2 (1.4)0
   Moderate2 (2.3)1 (1.5)1 (0.7)2 (1.7)
   Severe0000
  Symptoms of hypoglycemia5 (5.8)2 (3.0)12 (8.6)5 (4.2)
   Mild4 (4.7)2 (3.0)11 (7.9)4 (3.4)
   Moderate1 (1.2)01 (0.7)1 (0.8)
   Severe0000
  • Data are presented as n (%).

  • *The following hypoglycemia definitions were used: major, event resulting in loss of consciousness, seizure, or coma (or other mental status change consistent with neuroglycopenia) that resolved after glucose or glucagon administration, or any event requiring third-party assistance to resolve due to severe impairment of consciousness or behavior associated with glucose concentration <3 mmol/L (54 mg/dL); minor, non-major hypoglycemia event with symptoms consistent with hypoglycemia and glucose concentration <3 mmol/L (54 mg/dL) prior to treatment; symptoms of hypoglycemia, events not meeting the criteria for major or minor hypoglycemic events.

  • AE, adverse event; QWS-AI, once-weekly suspension by autoinjector.