Introduction
death, cardiovascular death, N11005, hyperglycemia, PD, Diabetes, T2DM, diabetes
HYPERGLYCEMIA, DIABETES, TYPE 2 DIABETES MELLITUS, DIABETES
Diabetes is caused by a relative or absolute deficiency in insulin secretion in the patient’s body. There are two forms of normal insulin secretion: continuous secretion at basal state, i.e., basal insulin secretion, and secretion in response to exogenous stimuli (mainly meal-stimulated response), i.e., prandial insulin secretion. Abnormalities in the early phase of insulin secretion are early signs of insulin secretion defects in the progress of Type 2 diabetes mellitus (T2DM) and exist throughout the course of diabetes, which constitute the main cause of postprandial hyperglycemia that is an independent risk factor for all-cause death and fatal cardiovascular death (N11005 is an oral insulin with human insulin as its active ingredient. Drawing on studies related to insulin molecular structure, characteristics of solid self-microemulsifying preparations, and oral absorption of insulin, N11005 was developed and modified as a rapid-acting oral dosage form using Oralpas ProIn this study, we analyzed the PK, PD, and safety profiles of N11005 in healthy subjects by using the hyperinsulinemic-euglycemic clamp technique.