Factors associated with nocturnal hypoglycaemia among patients with type 2diabetes new to insulin therapy: experience with insulin lispro

Aim: To identify factors associated with nocturnal hypoglycaemia in patient s with type 2 diabetes who were new (< 2 months therapy) to insulin therapy . Methods: A randomised, multicentre, 12-month parallel open-label study comp ared the clinical safety and efficacy of insulin lispro with regular human insulin. A cohort of North American patients completed a health-related qua lity of life (HRQOL) questionnaire which included questions related to the Health Beliefs Model (HBM). Measurements of hypoglycaemia rate and short-an d long-term glucose control assessed clinical safety and efficacy. Three hu ndred and sixty-five type 2 diabetic patients were enrolled in the study, a nd 195 North American patients completed the HRQOL questionnaire. Results: After adjustment for demographic and psychological factors, the st udy population demonstrated lower nocturnal hypoglycaemia risk with insulin lispro. Higher nocturnal hypoglycaemia risk was associated with reduced bo dy mass index (b.m.i.), lower age, and basal ultralente insulin therapy. Th e associated hypoglycaemia risk was lower with increased alcohol consumptio n. Patients who completed the HRQOL survey demonstrated higher risk for noc turnal hypoglycaemia if they: (1) had more troublesome hyperglycaemia sympt oms in the week before starting insulin; (2) were more confident in their a bility to control their diabetes; or (3) thought that diabetes control did not offer a clear health benefit. Nocturnal hypoglycaemia risk was inversel y associated with fear of hypoglycaemia. Conclusions: Type 2 diabetic patients new to insulin therapy demonstrated l ower risk of nocturnal hypoglycaemia with insulin lispro. Practitioners sho uld consider patient characteristics and psychological factors that may pre dispose type 2 diabetes patients to nocturnal hypoglycaemia when initiating insulin therapy.