Table 2. Frequency distribution of adverse events with a possible or probable relationship with the trial product over the 28‐week treatment period.
| Adverse events (preferred term) | BIAsp70 (n = 144) | BIAsp30 (n = 144) | ||||
|---|---|---|---|---|---|---|
| n | % | E | n | % | E | |
| Total | 24 | 16.7 | 27 | 20 | 13.9 | 27 |
| Eye disorders | 12 | 8.3 | 12 | 7 | 4.9 | 8 |
| Diabetic retinopathy | 10 | 6.9 | 10 | 5 | 3.5 | 6 |
| Cataract | 2 | 1.4 | 2 | 0 | 0.0 | 0 |
| Maculopathy | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Retinal hemorrhage | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Investigations | 9 | 6.3 | 9 | 3 | 2.1 | 4 |
| Weight increased | 3 | 2.1 | 3 | 0 | 0.0 | 0 |
| γ‐GTP increased | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Blood amylase increased | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Blood potassium increased | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Blood cholesterol increased | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| LDH increased | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| ECG | ||||||
| ST‐T segment abnormal | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| T wave inversion | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Signs of ventricular hypertrophy | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| T wave amplitude decreased | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Q wave abnormal | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| General disorders | 2 | 1.4 | 2 | 3 | 2.1 | 3 |
| Injection site urticaria | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Edema peripheral | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Feeling abnormal | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Chest pain | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Injection site induration | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Metabolism/nutrition disorders | 1 | 0.7 | 1 | 3 | 2.1 | 4 |
| Hypoglycemia | 1 | 0.7 | 1 | 2 | 1.4 | 3 |
| Hyperuricemia | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Vascular disorders | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Hypertension | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Ear/labyrinth disorders | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Vertigo | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Neoplasms | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Gastric cancer | 1 | 0.7 | 1 | 0 | 0.0 | 0 |
| Nervous system disorders | 0 | 0.0 | 0 | 2 | 1.4 | 2 |
| Hypoglycemic coma | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Diabetic neuropathy | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Cardiac disorders | 0 | 0.0 | 0 | 1 | 0.7 | 2 |
| Atrial fibrillation | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| AV block first degree | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Skin disorders | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Hemorrhage subcutaneous | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Gastrointestinal disorders | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Gastric mucosal lesion | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Hepatobiliary disorders | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
| Liver function abnormal | 0 | 0.0 | 0 | 1 | 0.7 | 1 |
E, number of episodes; ECG, electrocardiogram; γ‐GTP, gamma‐glutamyl transpeptidase; LDH, lactic dehydrogenase; n, number of subjects reported with adverse events; %, proportion of subjects with adverse events.