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Table 2—

Safety summary of adverse experiences

PlaceboSitagliptin 100 mg q.d.Sitagliptin 200 mg q.d.
n 253 238 250 
One or more clinical AE 167 (66.0) 157 (66.0) 160 (64.0) 
Drug-related clinical AE* 19 (7.5) 23 (9.7) 27 (10.8) 
Clinical SAE 9 (3.6) 12 (5.0) 12 (4.8) 
Drug-related clinical SAE* 1 (0.4) 2 (0.8) 0 (0) 
Discontinuation due to AE 4 (1.6) 5 (2.1) 4 (1.6) 
Discontinuation due to drug-related AE 2 (0.8) 1 (0.4) 0 (0) 
Discontinuation due to SAE 3 (1.2) 3 (1.3) 3 (1.2) 
Discontinuation due to drug-related SAE 1 (0.4) 0 (0) 0 (0) 
Hypoglycemia 2 (0.8) 3 (1.3) 2 (0.8) 
Overall gastrointestinal AE 29 (11.5) 39 (16.4) 41 (16.4) 
Prespecified selected gastrointestinal AE    
    Abdominal pain§ 4 (1.6) 5 (2.1) 3 (1.2) 
    Nausea§ 3 (1.2) 5 (2.1) 10 (4.0) 
    Vomiting§ 3 (1.2) 3 (1.3) 2 (0.8) 
    Diarrhea§ 6 (2.4) 11 (4.6) 10 (4.0) 
PlaceboSitagliptin 100 mg q.d.Sitagliptin 200 mg q.d.
n 253 238 250 
One or more clinical AE 167 (66.0) 157 (66.0) 160 (64.0) 
Drug-related clinical AE* 19 (7.5) 23 (9.7) 27 (10.8) 
Clinical SAE 9 (3.6) 12 (5.0) 12 (4.8) 
Drug-related clinical SAE* 1 (0.4) 2 (0.8) 0 (0) 
Discontinuation due to AE 4 (1.6) 5 (2.1) 4 (1.6) 
Discontinuation due to drug-related AE 2 (0.8) 1 (0.4) 0 (0) 
Discontinuation due to SAE 3 (1.2) 3 (1.3) 3 (1.2) 
Discontinuation due to drug-related SAE 1 (0.4) 0 (0) 0 (0) 
Hypoglycemia 2 (0.8) 3 (1.3) 2 (0.8) 
Overall gastrointestinal AE 29 (11.5) 39 (16.4) 41 (16.4) 
Prespecified selected gastrointestinal AE    
    Abdominal pain§ 4 (1.6) 5 (2.1) 3 (1.2) 
    Nausea§ 3 (1.2) 5 (2.1) 10 (4.0) 
    Vomiting§ 3 (1.2) 3 (1.3) 2 (0.8) 
    Diarrhea§ 6 (2.4) 11 (4.6) 10 (4.0) 

Data are n (%).

*

Considered by investigator as possibly, probably, or definitely related to study drug;

includes one hypoglycemia episode occurring after initiation of glycemic rescue therapy (metformin);

excludes adverse experiences after initiating glycemic rescue therapy (metformin).

§

P > 0.05 for sitagliptin (100 or 200 mg) vs. placebo. AE, adverse experience; SAE, serious adverse experience.

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