Pio + SU n = 1709 | Pio + Met n = 1496 | SU + Met n = 1380 | |
---|---|---|---|
Hypoglycemic episodes | |||
At least one | 175 (10.3) [2] | 91 (6.1) [6] | 134 (9.7) [1] |
Severe | 5 (0.3) [36] | 4 (0.3) [36] | 5 (0.4) [26] |
Adverse events | [0] | [0] | [0] |
At least one adverse event | 113 (6.6) | 98 (6.6) | 73 (5.3) |
Related to study treatments* | 70 (4.1) | 60 (4.0) | 28 (2.0) |
Gastrointestinal disorders | 13 (0.8) | 15 (1.0) | 15 (1.1) |
General disorders | 28 (1.6) | 25 (1.7) | 3 (0.2) |
Edema | 26 (1.5) | 22 (1.5) | 2 (0.1) |
At least one serious adverse event | 13 (0.8) | 10 (0.7) | 12 (0.9) |
Description of all serious AEs (by body system): | |||
Cardiac disorders | 4 (0.2) | 2 (0.1) | 2 (0.1) |
Gastrointestinal disorders | - | - | 1 (0.1) |
General disorders | - | - | 1 (0.1) |
Infections and infestations | - | 2 (0.1) | - |
Injury, poisoning, and procedural complications | 1 (0.1) | - | - |
Metabolism and nutrition disorders | 1 (0.1) | - | - |
Neoplasm | 2 (0.1) | 1 (0.1) | 2 (0.1) |
Nervous system disorders | 3 (0.2) | 2 (0.1) | 2 (0.1) |
Renal and urinary disorders | - | - | 1 (0.1) |
Reproductive system and breast disorders | - | 1 (0.1) | - |
Respiratory, thoracic, and mediastinal disorders | 1 (0.1) | - | - |
Skin and subcutaneous tissue disorders | 1 (0.1) | 1 (0.1) | - |
Surgical and medical procedures | 1 (0.1) | 1 (0.1) | 1 (0.1) |
Vascular disorders | - | - | 2 (0.1) |