Aims: The aim of the study was to evaluate whether freshly available concentrated U-200 lispro insulin performed equally to previously marketed U-200 insulin lispro in terms of glycemic control and patient satisfaction. Methods: 360 outpatients with type 2 diabetes (T2DM) having self-injected U-100 lispro Kwikpen (KP) before meals for a long time were randomly selected to either going on with their usual treatment schedule (control group, n=180, CG) or switching to U-200 lispro KP for 12-weeks (treated group, n=180, TG) and filling in a treatment satisfaction questionnaire at the end of the observation period. They were all assessed for changes in body weight, blood pressure, BMI, fasting blood glucose, HbA1c, total cholesterol, HDL cholesterol, tryglicerides, uric acid, creatinine clearance rate with respect to baseline. Results: No significant changes were observed in the CG. Conversely, the TG displayed significantly decreased hypoglycemic episodes (p<0.001), as well as, fasting plasma glucose levels and glucose variability (p<0.01) compared to baseline. According to the questionnaire, 60 to 81% TG people were very satisfied with U-200 lispro KP and most of them preferred to stick to the new insulin preparation. Conclusions: hypoglycemic event rates, fasting blood glucose, glycemic variability and subjective ratings significantly improved in people treated with U-200 lispo. Diversity in both molecular insulin concentration and injection device engineering showed to provide better results in U-200 treated patients utilizing the same drug as controls.
Alessandra Fusco, Sara Colarusso, Marco Piscopo, Maria Rosaria Improta and Marco Corigliano