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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.