Table 3—

Clinical adverse experience summary

Patients*PlaceboSitagliptin 100 mg q.d.Metformin 500 mg b.i.d.Metformin 1,000 mg b.i.d.Sitagliptin 50 mg + metformin 500 mg b.i.d.Sitagliptin 50 mg + metformin 1,000 mg b.i.d.Open-label cohort
n176179182182190182117
One or more adverse experiences89 (50.6)96 (53.6)101 (55.5)113 (62.1)110 (57.9)105 (57.7)69 (59.0)
Drug-related adverse experiences17 (9.7)12 (6.7)21 (11.5)30 (16.5)24 (12.6)28 (15.4)23 (19.7)
Serious adverse experiences10 (5.7)9 (5.0)4 (2.2)2 (1.1)6 (3.2)1 (0.5)3 (2.6)
Drug-related serious adverse experiences1 (0.6)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Who died1 (0.6)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Discontinued due to adverse experiences7 (4.0)5 (2.8)4 (2.2)5 (2.7)5 (2.6)2 (1.1)3 (2.6)
Discontinued due to drug-related adverse experiences2 (1.1)0 (0.0)2 (1.1)5 (2.7)2 (1.1)1 (0.5)2 (1.7)
Discontinued due to serious adverse experiences5 (2.8)4 (2.2)2 (1.1)0 (0.0)1 (0.5)0 (0.0)0 (0.0)
Discontinued due to drug-related serious adverse experiences1 (0.6)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Special adverse experiences of interest
    Hypoglycemia1 (0.6)1 (0.6)1 (0.5)2 (1.1)2 (1.1)4 (2.2)2 (1.7)
    All gastrointestinal adverse experiences19 (10.8)27 (15.1)29 (15.9)46 (25.3)34 (17.9)45 (24.7)32 (27.4)
Selected gastrointestinal adverse experiences
    Diarrhea7 (4.0)5 (2.8)9 (4.9)19 (10.4)12 (6.3)16 (8.8)10 (8.5)
    Nausea2 (1.1)2 (1.1)5 (2.7)15 (8.2)8 (4.2)10 (5.5)7 (6.0)
    Abdominal pain4 (2.3)6 (3.4)5 (2.7)9 (4.9)5 (2.6)6 (3.3)6 (5.1)
    Vomiting1 (0.6)0 (0.0)0 (0.0)2 (1.1)2 (1.1)6 (3.3)4 (3.4)
  • Data are n (%).

  • * Excludes data after initiation of glycemic (glyburide/glibenclamide) rescue therapy.

  • Open-label cohort treated with sitagliptin 50 mg + metformin 1,000 mg b.i.d.

  • Considered by the investigator to be drug related.