Table 2

Summary of adverse events (safety population)

Sitagliptin + imeglimin 1,500 mg b.i.d.
(N = 82)Sitagliptin + placebo
(N = 88)
Sitagliptin run-inDouble-blind treatment periodSitagliptin run-inDouble-blind treatment period
n (%)En (%)En (%)En (%)E
Any TEAEs12 (14.6)1812 (14.6)1512 (13.6)1320 (22.7)28
Any related TEAEs2 (2.4)50 (0.0)00 (0.0)03 (3.4)7
Gastrointestinal1 (1.2)10 (0.0)00 (0.0)01 (1.1)3
 Upper abdominal pain0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
 Constipation1 (1.2)10 (0.0)00 (0.0)00 (0.0)0
 Vomiting0 (0.0)00 (0.0)00 (0.0)01 (1.1)2
Investigations0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
 Weight increased0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
Metabolism1 (1.2)40 (0.0)00 (0.0)02 (2.3)2
 Hyperglycemia0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
 Hypoglycemia1 (1.2)40 (0.0)00 (0.0)00 (0.0)0
 Increased appetite0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
CNS0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
 Headache0 (0.0)00 (0.0)00 (0.0)01 (1.1)1
 Any SAE0 (0.0)01 (1.2)10 (0.0)00 (0.0)0
Any cardiovascular TEAE0 (0.0)00 (0.0)00 (0.0)00 (0.0)0
  • E, number of events; N, number of subjects exposed; n, number of subjects with adverse events; SAE, serious adverse event.