Table 2. Common adverse events.
Treatment-Emergent Adverse Events [1] | Placebo (N = 96) n (%) |
600 mg Met DR (N = 94) n (%) |
900 mg Met DR (N = 95) n (%) |
1200 mg Met DR (N = 96) n (%) |
1500 mg Met DR (N = 96) n (%) |
2000 mg Met IR (N = 94) n (%) |
All Subjects (N = 571) n (%) |
---|---|---|---|---|---|---|---|
Diarrhea | 0 | 7 (7.4) | 7 (7.4) | 11 (11.5) | 11 (11.5) | 13 (13.8) | 49 (8.6) |
Hyperglycemia | 10 (10.4) | 8 (8.5) | 10 (10.5) | 7 (7.3) | 8 (8.3) | 5 (5.3) | 48 (8.4) |
Nausea | 1 (1.0) | 3 (3.2) | 3 (3.2) | 1 (1.0) | 3 (3.1) | 9 (9.6) | 20 (3.5) |
Upper respiratory tract infection | 2 (2.1) | 1 (1.1) | 5 (5.3) | 1 (1.0) | 0 | 2 (2.1) | 11 (1.9) |
Worsening Type 2 diabetes mellitus | 5 (5.2) | 3 (3.2) | 1 (1.1) | 0 | 0 | 0 | 9 (1.6) |
[1] Treatment-emergent adverse events are defined as those occurring at or after the first administration of randomized study medication at Visit 3 (Day 1) through Study Termination, or existing prior to the time of, and worsening after the time of the first administration of randomized study medication