Seventeen studies (at least 2,700 participants) were included in the review, of which sixteen were RCTs.
Hypoglycaemia (11 studies): the incidence of hypoglycaemia was similar for patients taking BIAsp 30 and other types of insulin. Hypoglycaemia was reported by between 43% and 57% of patients in the BIAsp 30 groups compared with a range of 32 to 57% for patients given BHI 30 and 28% of those taking NPH insulin.
Major hypoglycaemia (9 studies): major hypoglycaemic episodes were less common in patients receiving BIAsp 30, being reported by between 2% and 8% of patients given BIAsp 30 compared with a range of 2 to 14% for patients in the BHI 30 groups.
Nocturnal hypoglycaemia (3 studies): one study found no significant difference between BIAsp 30 and BHI 30, one reported a significant reduction in nocturnal hypoglycaemia (p=0.02), and one reported no statistical results.
Minor hypoglycaemia (3 studies): the majority of the studies found no difference between the groups in the incidence of minor hypoglycaemia.
Weight gain (7 studies): all of the studies that assessed weight gain reported that patients gained weight while taking BIAsp 30. Where comparative statistics were reported, one trial reported a trend to a lower increase in the mean weight gain in the BIAsp 30 group than in the BHI 30 group (p=0.07), while another found patients given BIAsp 30 or BHI 30 gained significantly more weight than patients given NPH insulin (p=0.025).
Other adverse events (7 studies): adverse events were reported in between 36% and 90% of patients treated with BIAsp 30 compared with 38 to 88% of patients receiving BHI 30, 38% of patients taking NPH insulin, and 51% of patients taking Mix 25. Few patients in any study discontinued treatment as a result of adverse events associated with either BIAsp 30 or comparator insulins. Where cardiovascular events occurred, the rates were comparable in the BIAsp 30 and BHI 30 groups. No major biochemical changes were observed.