Improved postprandial glycemic control with humalog ® mix75/25 ™ after a standard test meal in patients with type 2 diabetes mellitus

This double-blind study was designed to compare the postprandial glucodynamic profile of Humalog ® Mix75/25 ™, a new premixed insulin analogue containing 75% neutral protamine lispro and 25% insulin lispro with that of human insulin 70/30 (70% neutral protamine Hagedorn insulin and 30% regular human insulin) in patients with type 2 diabetes mellitus. Insulin lispro Mix75/25 (Mix75/25) is the first available insulin formulation in which both the rapid-acting and basal components are insulin analogues. This randomized, multicenter, double-blind, crossover study monitored patients' postprandial glucodynamic response to Mix75/25 and human insulin 70/30 (70/30) after a standard test meal. Eighty-four patients with type 2 diabetes participated in this study and were randomly assigned to 1 of 2 treatment sequence groups. Patients received an identical test meal on 4 occasions, completing 2 test meals for each treatment. Equal doses of Mix75/25 or 70/30 were administered 5 minutes before each of the 2 test meals, with doses individualized for each patient. Blood samples were collected for 4 hours after the meal for measurement of plasma glucose. From these plasma glucose measurements, fasting plasma glucose, 2-hour postprandial glucose (2pp), 2-hour postprandial glucose excursion (2pp ex), maximum glucose excursion (Gex max), the area under the glucose concentration versus time curve from 0 to 4 hours (AUC 4), and the area under the glucose excursion versus time curve from 0 to 4 hours (AUCex 4) were calculated. Because of significant differences in the baseline fasting plasma glucose levels between Mix75/25 and 70/30 (Mix75/25: 8.9 ± 2.2 mmol/L [160.2 ± 39.6 mg/dL]; 70/30: 8.6 ± 1.9 mmol/L [154 ± 34 mg/dL), analyses of the excursion parameters provide a truer comparison of the glucodynamic response between insulin formulations. Mix75/25 resulted in significantly lower values for 2pp ex (3.35 ± 2.28 vs 4.13 ± 2.26 mmol/L), Gex max (4.51 ± 1.88 vs 5.19 ± 1.98 mmol/L), and AUCex 4 (8.01 ± 7.02 vs 10.6 ± 6.47 mmol·h/L) compared with 70/30. In patients with type 2 diabetes mellitus, premeal injection of Mix75/25 resulted in better postprandial glycemic control than did premeal injection of 70/30 in the 4 hours after a standard meal. Mix75/25 is a valuable option for managing postprandial blood glucose in patients with type 2 diabetes mellitus who require insulin.