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Table 3 Summary of safety data

From: A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus

  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
  1. aThe TEAEs and serious TEAEs during the on-treatment period were presented by preferred terms
  2. bBlood glucose increase
  3. cPatients may have experienced more than one adverse event
  4. TEAE treatment emergent adverse event, AGA anti-glargine antibody, AIA anti-insulin antibody, SD standard deviation