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Table 7 Clinical adverse experiences considered to be related to study drug that occurred at an incidence rate of ≥0.5% in any group

From: Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis

  Sitagliptin 100 mg
n (%)
(N = 3415)
Non-Exposed
n (%)
(N = 2724)
Difference between Sitagliptin
and Non-Exposed
% (95% CI)*
Abdominal Pain Upper 18 (0.5) 11 (0.4) 0.1 (-0.2, 0.5)
Constipation 25 (0.7) 13 (0.5) 0.3 (-0.2, 0.7)
Diarrhea 42 (1.2) 45 (1.7) -0.4 (-1.1, 0.2)
Dyspepsia 19 (0.6) 13 (0.5) 0.1 (-0.3, 0.4)
Nausea 33 (1.0) 31 (1.1) -0.2 (-0.7, 0.3)
Fatigue 19 (0.6) 20 (0.7) -0.2 (-0.6, 0.2)
Peripheral Edema 11 (0.3) 16 (0.6) -0.3 (-0.7, 0.1)
Blood Glucose 6 (0.2) 16 (0.6) -0.4 (-0.8, -0.1)
Decreased    
Hypoglycemia 87 (2.5) 203 (7.5) -4.9 (-6.1, -3.8)
Dizziness 17 (0.5) 13 (0.5) 0.0 (-0.4, 0.4)
Headache 37 (1.1) 29 (1.1) 0.0 (-0.5, 0.5)
  1. CI = confidence interval
  2. *Positive differences indicate that the incidence rate for the sitagliptin group is higher than the incidence rate for the non-exposed group. "0.0" and "-0.0" represent rounding for values that are slightly greater and slightly less than zero, respectively.
  3. Determined by the investigator to be possibly, probably, or definitely drug-related.
  4. Includes studies in which a sulfonylurea was an active comparator or a background agent.