Table 2—

Safety summary

Safety parameterPlaceboSitagliptin 100 mg q.d.
n237464
Patients with one or more clinical adverse experience128 (54.0)262 (56.5)
Patients with drug-related clinical adverse experiences*25 (10.5)45 (9.7)
Patients with serious clinical adverse experiences7 (3.0)13 (2.8)
Patients with drug-related serious clinical adverse experiences00
Patients who discontinued due to clinical adverse experiences7 (3.0)11 (2.4)
Patients who discontinued due to drug-related clinical adverse experiences04 (0.9)
Patients who discontinued due to serious clinical adverse experiences1 (0.4)6 (1.3)
Patients who discontinued due to serious drug-related clinical adverse experiences00
Hypoglycemia5 (2.1)6 (1.3)
Overall gastrointestinal adverse experiences25 (10.5)55 (11.9)
Selected gastrointestinal adverse experiences
    Abdominal pain9 (3.8)10 (2.2)
    Diarrhea6 (2.5)12 (2.6)
    Nausea2 (0.8)6 (1.3)
    Vomiting2 (0.8)5 (1.1)
  • Data are n (%).

  • *

    * Determined by the investigator to be possibly, probably, or definitely drug related.

  • Includes five patients who discontinued during the initial placebo-controlled phase and two patients who discontinued after completing this phase because of adverse experiences that had an onset during the placebo-controlled phase.