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) |