Reported hypoglycaemia with insulin lispro low mixture (LM25; insulin lispro protamine suspension 75% and insulin lispro solution 25%) twice daily or basal insulin glargine once daily and prandial insulin lispro once daily (IGL) in patients with type 2 diabetes
| Hypoglycaemia | LM25 (N = 236) | IGL (N = 240) | ||
|---|---|---|---|---|
| Patients with ≥1 episode n (%) | No. of episodes per patient-year [mean (s.d.)] | Patients with ≥1 episode n (%) | No. of episodes per patient-year [mean (s.d.)] | |
| Overall (≤3.9 mmol/l) | 144 (61.0) | 13.07 (22.03) | 150 (62.5) | 16.51 (26.44) |
| Documented symptomatic (≤3.9 mmol/l) | 109 (46.2) | 7.21 (14.55) | 110 (45.8)* | 7.72 (15.67) |
| Asymptomatic (≤3.9 mmol/l) | 97 (41.1) | 5.18 (12.62) | 109 (45.4) | 8.34 (18.00) |
| Nocturnal | 50 (21.2) | 1.54 (4.58) | 52 (21.7) | 1.82 (5.25) |
| Severe | 2 (0.8)† | 0.04 (0.45) | 0 | 0 |
Documented symptomatic hypoglycaemia (≤3.9 mmol/l) was defined as any event during which typical symptoms of hypoglycaemia are accompanied by a measured plasma glucose concentration ≤3.9 mmol/l. Asymptomatic hypoglycaemia ≤3.9 mmol/l was defined as any event not accompanied by typical symptoms of hypoglycaemia but with a measured plasma glucose concentration ≤3.9 mmol/l. Nocturnal hypoglycaemia was defined as any hypoglycaemic event that occurred between bedtime and waking. Severe hypoglycaemia was defined as any hypoglycaemic event in which the patient required the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions; the blood glucose concentration may not have been measured during the event, but neurologic recovery that was attributable to the restoration of a normal blood glucose concentration was considered as sufficient evidence that the event was induced by a low-plasma glucose concentration. Between-treatment differences were not significant (p > 0.05).
*One patient discontinued treatment because of hypoglycaemia.
†Neither patient required discontinuation of treatment.