Insulin glulisine imparts effective glycaemic control in patients with Type 2 diabetes.

Background: Insulin glulisine (glulisine) was evaluated versus regular human insulin (RHI) in Type 2 diabetes (T2DM) patients.

Methods: Patients previously on >6 months' continuous insulin treatment aged >or=18 years in a randomized, multinational, controlled, open-label, parallel group, 26-week study received twice-daily NPH insulin and either glulisine (0-15 min before breakfast and dinner; n=448) or RHI (30-45 min before breakfast and dinner; n=442) at least twice daily.

Results: Mean baseline characteristics were similar between groups. There were no differences in baseline to endpoint HbA(1c) reductions (glulisine: -0.32%; RHI: -0.35%; p=0.5726), and the non-inferiority of glulisine versus RHI was demonstrated (difference in adjusted mean change 0.03%; 95% CI: -0.07, 0.13). Postprandially, glulisine lowered plasma glucose significantly more versus RHI at 2h (14.14 mmol/L versus 15.28 mmol/L; p=0.0025) and excursions at 1h (3.99 versus 4.59; p=0.0151) and 2h (4.87 versus 6.03; p=0.0002). No between-group differences occurred in the frequencies and monthly rates of all symptomatic hypoglycaemia; nocturnal hypoglycaemia from Month 4 to treatment end was less frequent with glulisine versus RHI (9.1% versus 14.5%; p=0.029).

Conclusions: Glulisine was non-inferior to RHI in reducing HbA(1c) in T2DM. Glulisine demonstrated superior postprandial glucose control and was associated with fewer nocturnal hypoglycaemic episodes, indicating clinical benefits.