Table 3 Adverse events.

Adverse events.. Data are provided as n (%).

TTP399 (400 mg)
(n = 50)
TTP399 (800 mg)
(n = 42)
Sitagliptin
(n = 49)
Placebo
(n = 48)
Patients with ≥1 TEAE26 (52.0)21 (50.0)30 (61.2)29 (60.4)
Serious AEs0 (0)0 (0)0 (0)0 (0)
Patients with ≥1 treatment-
related AEs
3 (6.0)8 (19.0)8 (16.3)4 (8.3)
AE leading to withdrawal0 (0)4 (9.5)3 (6.1)1 (2.1)
AEs occurring in ≥5%
  Headache6 (12.0)2 (4.8)4 (8.2)2 (4.2)
  Upper respiratory tract
infection
6 (12.0)1 (2.4)2 (4.1)2 (4.2)
  Diarrhea2 (4.0)3 (7.1)3 (6.1)2 (4.2)
  Nausea2 (4.0)3 (7.1)3 (6.1)1 (2.1)
  Hypoglycemia0 (0)3 (7.1)2 (4.1)2 (4.2)
  Urinary tract infection4 (8.0)1 (2.4)1 (2.0)1 (2.1)
  Cough2 (4.0)1 (2.4)3 (6.1)0 (0)
  Nasopharyngitis0 (0)0 (0)2 (4.1)3 (6.3)
Hypoglycemia AEs
  Number of hypoglycemic
events
0 (0)327
  Patients with ≥1
hypoglycemic event
0 (0)3 (7.1)2 (4.1)3 (6.30)
  Severe hypoglycemia0 (0)0 (0)0 (0)0 (0)
  Documented symptomatic
hypoglycemia
0 (0)1 (2.4)1 (2.0)1 (2.1)
  Probable symptomatic
hypoglycemia
0 (0)2 (4.8)1 (2.0)1 (2.1)
  Relative hypoglycemia0 (0)0 (0)0 (0)1 (2.1)