Safety summary of adverse experiences
| . | Placebo . | Sitagliptin 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) |
| . | Placebo . | Sitagliptin 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.