Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes

Table 9 Select gastrointestinal and hypoglycemia adverse events: Predefined primary analysis, which excluded data after initiation of glycemic rescue therapy

Adverse Event	Incidence Rate per 100 Patient-years^†
	Sitagliptin 100 mg	Non-exposed	Difference between Sitagliptin and Non-exposed (95% CI)*
Gastrointestinal disorders SOC
One or more select event (abdominal pain^‡, diarrhea, nausea, vomiting)	14.0	17.2	-2.9 (-4.8, -1.1)
Abdominal pain^‡	4.1	4.7	-0.7 (-1.7, 0.3)
Diarrhea	7.1	10.0	-2.5 (-3.9, -1.1)
Nausea	3.1	4.0	-0.7 (-1.6, 0.2)
Vomiting	1.9	1.9	0.0 (-0.6, 0.6)
Metabolism and nutrition disorders SOC
Hypoglycemia	4.9	11.7	-6.7 (-8.2, -5.3)

CI = confidence interval;
^†100 * (number of patients with ≥ 1 event/person years of follow-up time).
* Between-group difference and 95% CI based on stratified analysis. 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.
^‡Abdominal pain includes abdominal pain, upper and lower abdominal pain, and abdominal and epigastric discomfort.

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