Table 3 Summary of safety data
Insulin glargine | NPH insulin | |
|---|---|---|
(n = 107) | (n = 54) | |
Mean duration of study treatment, days ± SD | 167.5 ± 9.6 | 157.6 ± 38.9 |
Treatment discontinuation, n (%) | 1 (1) | 4 (7.3) |
Due to TEAEa, n (%) | 0 (0) | 1 (1.9)b |
≥1 treatment-related TEAEa, n (%) | 37 (34.6) | 24 (44.4) |
Hypoglycaemia | 36 (33.6) | 22 (40.7) |
Overweight | 1 (0.9%) | 1 (1.9) |
Dizziness | 0 (0) | 1 (1.9) |
Injection site swelling | 0 (0) | 1 (1.9) |
Hunger | 0 (0) | 1 (1.9) |
Blood glucose increased | 0 (0) | 1 (1.9) |
Serious TEAE,ac n (%) | 4 (2.8) | 6 (11.1) |
Diabetic ketoacidosis | 2 (1.9) | 3 (5.6) |
Mumps | 1 (0.9) | 0 (0) |
Acute pancreatitis | 1 (0.9) | 0 (0) |
Blood glucose increase | 0 (0) | 1 (1.9) |
Hypoglycaemia | 0 (0) | 1 (1.9) |
Respiratory tract infection | 0 (0) | 1 (1.9) |
AGA-positive, n/n (%) | ||
Screening | 74/107 (69.2) | 43/55 (78.2) |
Week 24 | 69/106 (65.1) | 39/50 (78.0) |
Shift from negative to positive, n/n (%) | 7/32 (21.9) | 5/10 (50.0) |
Shift from positive to negative, n/n (%) | 12/74 (16.2) | 6/40 (15.0) |
AGA titre, mean ± SD | ||
Screening | 41.4 ± 90.2 | 41.3 ± 86.9 |
Week 24 | 56.6 ± 150.9 | 28.8 ± 44.3 |
AIA-positive, n (%) | ||
Baseline | 65/107 (60.7) | 38/55 (69.1) |
Week 24 | 60/106 (56.6) | 38/50 (76.0) |
Shift from negative to positive, n/n (%) | 5/41 (12.2) | 5/14 (35.7) |
Shift from positive to negative, n/n (%) | 10/65 (15.4) | 2/35 (5.7) |
AIA titre, mean ± SD | ||
Screening | 69.2 ± 177.1 | 50.1 ± 63.9 |
Week 24 | 66.9 ± 169.0 | 33.7 ± 34.0 |