Improved postprandial glycemic control with Humalog® Mix75/25™ after a standard test meal in patients with type 2 diabetes mellitus

Objective: This double-blind study was designed to compare the postprandial glucodynamic profile of Humalog(R) Mix75/25(TM), 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. Background: Insulin lispro Mix75/25 (Mix75/25) is the first available insulin formulation in which both the rapid-acting and basal components are insulin analogues. Methods: 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. Results: 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. Conclusions: 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.