Table 2—

Safety summary of adverse experiences

PlaceboSitagliptin 100 mg q.d.Sitagliptin 200 mg q.d.
n253238250
One or more clinical AE167 (66.0)157 (66.0)160 (64.0)
Drug-related clinical AE*19 (7.5)23 (9.7)27 (10.8)
Clinical SAE9 (3.6)12 (5.0)12 (4.8)
Drug-related clinical SAE*1 (0.4)2 (0.8)0 (0)
Discontinuation due to AE4 (1.6)5 (2.1)4 (1.6)
Discontinuation due to drug-related AE2 (0.8)1 (0.4)0 (0)
Discontinuation due to SAE3 (1.2)3 (1.3)3 (1.2)
Discontinuation due to drug-related SAE1 (0.4)0 (0)0 (0)
Hypoglycemia2 (0.8)3 (1.3)2 (0.8)
Overall gastrointestinal AE29 (11.5)39 (16.4)41 (16.4)
Prespecified selected gastrointestinal AE
    Abdominal pain§4 (1.6)5 (2.1)3 (1.2)
    Nausea§3 (1.2)5 (2.1)10 (4.0)
    Vomiting§3 (1.2)3 (1.3)2 (0.8)
    Diarrhea§6 (2.4)11 (4.6)10 (4.0)
  • Data are n (%).

  • *

    * Considered by investigator as possibly, probably, or definitely related to study drug;

  • includes one hypoglycemia episode occurring after initiation of glycemic rescue therapy (metformin);

  • excludes adverse experiences after initiating glycemic rescue therapy (metformin).

  • §

    § P > 0.05 for sitagliptin (100 or 200 mg) vs. placebo. AE, adverse experience; SAE, serious adverse experience.