Table 3. Safety and tolerability results.
| Weeks 0 –12[Link] (double‐blind) | Weeks 12–52 (open‐label) | |||
|---|---|---|---|---|
| Placebo (n = 63) | Sitagliptin (n = 70) | P/S (n = 63) | S/S (n = 68) | |
| No. patients (n [%]) who had one or more | ||||
| Clinical AE | 21 (33.3) | 28 (40.0) | 52 (82.5) | 54 (79.4) |
| Drug‐related[Link] clinical AE | 3 (4.8) | 6 (8.6) | 5 (7.9) | 4 (5.9) |
| Serious clinical AE | 1 (1.6) | 0 | 3 (4.8) | 5 (7.4) |
| Serious drug‐related‡ clinical AE | 0 | 0 | 0 | 0 |
| Number of patients (n [%]) who: | ||||
| Discontinued due to a clinical AE | 0 | 1 (1.4) | 2 (3.2) | 1 (1.5) |
| Discontinued due to a drug‐related‡ clinical AE | 0 | 1 (1.4) | 0 | 0 |
| Discontinued due to a serious clinical AE | 0 | 0 | 1 (1.6) | 1 (1.5) |
| Died | 0 | 0 | 0 | 0 |
| Number of patients (n [%]) who had: | ||||
| Hypoglycemia | 0 | 1 (1.4) | 0 | 1 (1.5) |
| Nausea, vomiting, or diarrhea | 1 (1.6) | 1 (1.4) | 3 (4.8) | 2 (2.9) |
| Number of patients (n [%]) who had one or more: | ||||
| Laboratory AE | 5 (7.9) | 3 (4.3) | 11 (17.5) | 16 (23.5) |
| Serious laboratory AE | 0 | 0 | 0 | 0 |
| Drug‐related‡ laboratory AE | 1 (1.6) | 1 (1.4) | 4 (6.3) | 1 (1.5) |
| Number of patients (n [%]) who: | ||||
| Discontinued due to a laboratory AE | 0 | 0 | 0 | 0 |
| Number of patients (n [%]) who had: | ||||
| Clinical AE§ | ||||
| Nasopharyngitis | 4 (6.3) | 5 (7.1) | 19 (30.2) | 21 (30.9) |
| Cataract | 0 | 2 (2.9) | 1 (1.6) | 5 (7.4) |
| Erosive gastritis | 0 | 0 | 0 | 4 (5.9) |
| Back pain | 1 (1.6) | 1 (1.4) | 4 (6.3) | 4 (5.9) |
| Eczema | 2 (3.2) | 1 (1.4) | 2 (3.2) | 4 (5.9) |
| Laboratory AE§ | ||||
| Blood triglycerides increased | 0 | 1 (1.4) | 3 (4.8) | 5 (7.4) |
| Blood creatine phosphokinase increased | 1 (1.6) | 1 (1.4) | 1 (1.6) | 4 (5.9) |
†Fisher's exact test was used to test the significance of differences in weeks 0 –12 between numbers of patients in the sitagliptin and placebo groups reported to have one or more clinical (or laboratory) adverse experience (AE) overall, drug‐related clinical (or laboratory) AE, occurrence of hypoglycemia or prespecified gastrointestinal AE (nausea, vomiting and diarrhea). All between‐group differences were non‐significant. ‡Considered to be possibly, probably or definitely treatment‐related by the study investigators. §Specific AEs for which there was a ≥5% occurrence in either the sitagliptin or placebo group in the double‐blind period (from week 0 to 12), patients who received placebo during the double‐blind period and open‐label sitagliptin in the open‐label period (P/S) or patients who received sitagliptin during the double‐blind period and the open‐label period (S/S) group in the open‐label period (from week 12 to 52).