| Safety analysis population (n = 2602) | Efficacy analysis population (n = 1629) | |
| Number of patients with adverse drug reactions | 161 | 103 |
| Number of cases of adverse drug reactions | 175 | 114 |
| Incidence (%) of adverse drug reactions | 6.19% | 6.32% |
| Types of adverse drug reactions | Incidence of adverse drug reactions by type Number of patients (%) | |
| Metabolism and nutrition disorders | - | - |
| Hypoglycaemiaa) | 140 (5.38) | 90 (5.52) |
| Severe hypoglycaemia | 11 (0.42) | 7 (0.43) |
| Documented symptomatic hypoglycaemia | 54 (2.08) | 35 (2.15) |
| Nocturnal hypoglycaemia | 14 (0.54) | 6 (0.37) |
| Other hypoglycaemia | 91 (3.50) | 58 (3.56) |
| Diabetes mellitus inadequate control | 1 (0.04) | 0 (0.00) |
| Nervous system disorders | - | - |
| Diabetic neuropathy | 2 (0.08) | 2 (0.12) |
| Eye disorders | 1 (0.04) | 1 (0.06) |
| Diabetic retinopathy | 1 (0.04) | 1 (0.06) |
| Gastrointestinal disorders | 2 (0.08) | 2 (0.12) |
| Diarrhea* | 1 (0.04) | 1 (0.06) |
| Gastritis* | 1 (0.04) | 1 (0.06) |
| Hepatobiliary disorders | 2 (0.08) | 1 (0.06) |
| Hepatic function disorder | 2 (0.08) | 1 (0.06) |
| Skin and subcutaneous tissue disorders | 3 (0.12) | 2 (0.12) |
| Eczema | 1 (0.04) | 1 (0.06) |
| Rash | 1 (0.04) | 1 (0.06) |
| Pruritus generalised | 1 (0.04) | 0 (0.00) |
| Renal and urinary disorder | 1 (0.04) | 0 (0.00) |
| Dysuria* | 1 (0.04) | 0 (0.00) |
| General disorders and administration site conditions | 9 (0.35) | 6 (0.37) |
| Death* | 1 (0.04) | 1 (0.06) |
| Hunger* | 1 (0.04) | 1 (0.06) |
| Oedema | 1 (0.04) | 1 (0.06) |
| Injection site erythema | 2 (0.08) | 2 (0.12) |
| Injection site induration | 1 (0.04) | 1 (0.06) |
| Injection site pain | 1 (0.04) | 0 (0.00) |
| Injection site pruritus | 2 (0.08) | 1 (0.06) |
| Injection site rash | 1 (0.04) | 1 (0.06) |
| Injection site swelling | 1 (0.04) | 1 (0.06) |
| Injection site reaction | 1 (0.04) | 0 (0.00) |
| Laboratory tests | 9 (0.35) | 5 (0.31) |
| Alanine aminotransferase increased | 1 (0.04) | 1 (0.06) |
| Aspartate aminotransferase increased | 1 (0.04) | 1 (0.06) |
| Blood glucose level increased | 3 (0.12) | 1 (0.06) |
| Blood pressure increased* | 1 (0.04) | 1 (0.06) |
| HbA1c level increasedb) | 1 (0.04) | 1 (0.06) |
| Weight increased* | 1 (0.04) | 0 (0.00) |
| Anti-insulin antibody positive* | 2 (0.08) | 1 (0.06) |