Table 2

Patient safety through week 52 (safety population)

AlbiglutideSitagliptin
N249246
Overall AE incidence, n (%)
 Any AE208 (83.5)205 (83.3)
 Fatal AEs4 (1.6)4 (1.6)
 SAEs32 (12.9)36 (14.6)
 Drug-related AEs54 (21.7)34 (13.8)
 AEs leading to withdrawal of active treatment26 (10.4)26 (10.6)
Most common AEs, n (%)*
 Urinary tract infection23 (9.2)20 (8.1)
 Diarrhea25 (10.0)16 (6.5)
 Upper–respiratory tract infection14 (5.6)23 (9.3)
 Nasopharyngitis14 (5.6)20 (8.1)
 Hypertension14 (5.6)19 (7.7)
 Anemia16 (6.4)10 (4.1)
 Peripheral edema14 (5.6)8 (3.3)
 Constipation15 (6.0)6 (2.4)
GI disorders system organ class, n (%)
 Any event79 (31.7)62 (25.2)
 Nausea12 (4.8)8 (3.3)
 Vomiting4 (1.6)3 (1.2)
Hypoglycemic events, n (%)
 Any hypoglycemic event60 (24.1)39 (15.9)
  With background sulfonylurea56 (22.5)35 (14.2)
  Without background sulfonylurea4 (1.6)4 (1.6)
 Documented symptomatic29 (11.6)15 (6.1)
 Severe1 (0.4)4 (1.6)
ISRs, n (%)
 Any20 (8.0)9 (3.7)
 1–215 (75.0)9 (100.0)
 Total number of events8811
  Deemed mild70 (79.5)10 (90.9)
 ISR-related study withdrawals00
Potential systemic allergic reactions, n (%)
 Angioedema1 (0.4)1 (0.4)
 Anaphylaxis00
 Exfoliative rash01 (0.4)
 Lip swelling1 (0.4)0
 Face edema1 (0.4)0
Pancreatitis, n (%)^1 (0.4)0
Thyroid cancer, n (%)00
  • ISR, injection-site reaction.

  • *Occurred in ≥5% of patients in either treatment group.

  • †Potential allergic reactions were identified through a standard MedDRA query.

  • ^Preferred term of pancreatic pseudocyst.