Table 3.
AE summary through Week 14
| Placebo | MK-0941 dose (mg t.i.d. a.c.) |
||||
|---|---|---|---|---|---|
| 10 | 20 | 30 | 40 | ||
| n | 115 | 119 | 117 | 117 | 119 |
| ≥1 AEs | 58 (50.4) | 73 (61.3) | 75 (64.1) | 71 (60.7) | 73 (61.9) |
| Drug-related AEs† | 17 (14.8) | 20 (16.8) | 36 (30.8) | 32 (27.4) | 35 (29.7) |
| SAEs | 1 (0.9) | 4 (3.4) | 2 (1.7) | 4 (3.4) | 4 (3.4) |
| Drug-related SAEs† | 0 | 0 | 0 | 0 | 1 (0.8) |
| Discontinued owing to AEs | 3 (2.6) | 4 (3.4) | 3 (2.6) | 3 (2.6) | 6 (5.1) |
| Discontinued owing to drug-related AEs† | 1 (0.9) | 0 | 2 (1.7) | 1 (0.9) | 4 (3.4) |
| Discontinued owing to SAEs | 1 (0.9) | 0 | 0 | 0 | 1 (0.8) |
| Discontinued owing to drug-related SAEs† | 0 | 0 | 0 | 0 | 1 (0.8) |
| Specific AEs occurring with an incidence of ≥5% in any group | |||||
| Hypoglycemia | 40 (34.8) | 46 (38.7) | 61 (52.1)* | 54 (46.2) | 63 (53.4)* |
| Cataracts | 5 (4.3) | 8 (6.7) | 1 (0.9) | 5 (4.3) | 2 (1.7) |
| Diarrhea | 3 (2.6) | 6 (5.0) | 5 (4.3) | 3 (2.6) | 3 (2.5) |
| Influenza | 0 (0) | 6 (5.0) | 2 (1.7) | 8 (6.8) | 4 (3.4) |
| Nasopharyngitis | 1 (0.9) | 3 (2.5) | 9 (7.7) | 3 (2.6) | 6 (5.1) |
| Upper respiratory tract infection | 2 (1.7) | 4 (3.4) | 5 (4.3) | 7 (6.0) | 4 (3.4) |
| Headache | 2 (1.7) | 2 (1.7) | 10 (8.5) | 3 (2.6) | 4 (3.4) |
Data are n (%). For all end points except for hypoglycemia, this summary includes data after initiation of glycemic rescue therapy. For hypoglycemia, this summary excludes data after initiation of glycemic rescue therapy to eliminate the confounding effect of increased insulin dose. SAE, serious adverse event.
†Considered by the investigator to be drug related.
*P ≤ 0.01 vs. placebo (analysis of between-group difference relative to placebo was prespecified for hypoglycemia AEs).