Table 1

AEs while receiving therapy, to week 104

Placebo + metformin
(n = 101)Sitagliptin + metformin
(n = 302)Glimepiride + metformin
(n = 307)Albiglutide + metformin
(n = 302)
Overall safety to week 104
 Any AEs79.2/283.079.1/250.283.1/261.183.8/350.7
 SAEs12.9/10.78.9/5.69.4/6.511.9/10.1
 Related AEs20.8/24.417.9/30.617.6/19.431.1/101.4
 AEs leading to withdrawal5.0/3.13.6/2.14.6/2.66.6/3.8
Most common AEs (>7% with albiglutide)
 Upper respiratory tract infection9.9/7.39.3/7.08.5/6.516.2/12.4
 Diarrhea10.9/7.38.6/6.19.1/6.512.6/9.1
 Nausea10.9/7.96.6/5.36.2/3.710.3/9.3
 Injection-site reaction2.0/1.21.7/1.02.6/1.79.6/48.1
 Hypertension5.0/3.18.6/5.36.5/4.37.9/4.6
 Nasopharyngitis7.9/4.99.3/7.69.1/6.57.6/7.0
 Cough5.9/4.36.3/4.67.5/4.97.3/4.6
Hypoglycemia before rescue*
 Severe0000
 Documented symptomatic4 (4.0)/3.65 (1.7)/2.855 (17.9)/60.79 (3.0)/2.6
 Asymptomatic1 (1.0)/1.84 (1.3)/1.43 (1.0)/0.74 (1.3)/1.3
  • Data are incidence (percentage of patients with event) and event rate (events per 100 person-years). The order of AEs is based on albiglutide proportion in the overall data.

  • *Patients with more than one hypoglycemic event were counted in all severity categories reported. Percentages are based on the number of patients in each treatment group for the study being summarized. Severity was derived using the American Diabetes Association guidelines for categorization of hypoglycemic events, as follows: severe = required assistance of another person; documented symptomatic = typical symptoms accompanied by a plasma glucose concentration of ≤3.9 mmol/L; and asymptomatic = no symptoms but plasma glucose concentration ≤3.9 mmol/L.