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

Introduction: 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 >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 HbA1, 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 2 h (14.14 mmol/L versus 15.28 mmoVL; p = 0.0025) and excursions at 1 h (3.99 versus 4.59; p = 0.0151) and 2 h (4.87 versus 6.03; p = 0.0002). No between-group differences occurred in the frequencies and monthly rates of all symptomatic hypoglycaemia; noctumal hypoglycaernia from Month 4 to treatment end was less frequent with glulisine versus RHI (9. 1 % versus 14.5%; p = 0.029). Conclusion: Glulisine was non-infefiorto RHI in reducing HbAlc in T2DM. Glulisine demonstrated superior postprandial glucose control and was associated with fewer nocturnal hypoglycaemic episodes, indicating clinical benefits. (0 2006 Elsevier Ireland Ltd. All rights reserved.