Insulin glulisine provides improved glycemic control in patients with type 2 diabetes

OBJECTIVE - Insulin glulisine is a novel analog of human insulin designed for use as a 0 rapid-acting insulin. This study compared the safety and efficacy of glulisine With regular human insulin (RHI) in combination with NPH insulin. RESEARCH DESIGN AND METHODS - in total, 876 relatively well-controlled patients with type 2 diabetes (mean HbA(1c) 7.55%) were randomized and treated with glulisine/ NPH (n = 435) Or RHI/NPH (n = 441) for Up to 26 weeks in this randomized, multicenter, multinational, open-label, parallel-group study. Subjects were allowed to continue the same dose of prestudy regimens of oral antidiabetic agent (OAD) therapy (unless hypoglycemia necessitated a dose change). RESULTS - A slightly greater reduction from baseline to end point of HbA(1c). was seen in the glulisine group versus RHI (-0.46 vs. -0.30% with RHI; P = 0.0029). Also, at end point, lower postbreakfast (156 vs. 162 mg/dl [8-66 vs. 9.02 mmol/l] P < 0.05) and postdinner (154 vs..163 mg/dl [8.54 vs. 9.05 mmol/l]; P < 0.05) blood glucose levels were noted. Symptomatic hypeglycemia (overall, nocturnal, and severe) and weight gain were comparable between the two treatment groups. There were no between-group differences in baseline-to-end point changes in insulin dose. CONCLUSIONS - Twice-daily glulisine associated with NPH can provide small improvements in glycemic control compared with RHI in patients with type 2 diabetes who are already relatively well controlled on insulin alone or insulin plus OADs. The clinical relevance of such a difference remains to be established.