Table 3.
Summary of the main safety data during the study
| 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) |
* Listed if >1% in at least one cohort. Values within brackets indicate the number of patients with missing data for that variable. Data represent the numbers of patients, with percentages within parentheses.