Multicenter, open‑label, nonrandomized, observational safety study in subjects using insulin aspart in basal‑bolus regimen for the treatment of diabetes

INTRODUCTION: Basal-bolus insulin therapy is a standard method of intensifying diabetes treatment. A common adverse effect of such treatment is hypoglycemia. Data on frequency of hypoglycemia when fast-acting insulin analogue is used in everyday clinical practice is scarce. OBJECTIVES: The aim of the study was to investigate the risk of hypoglycemia after the use of insulin aspart in basal‑bolus therapy in patients with type 1 and 2 diabetes. PATIENTS AND METHODS: It was a multicenter, open‑label, noninterventional study. It involved 950 patients with type 1 and 1332 patients with type 2 diabetes who started preprandial insulin aspart in basal‑bolus regimen. Patients were followed for 13 weeks. The primary endpoint was the incidence of major daytime and nocturnal hypoglycemic events assessed on the basis of patients’ self‑reports during follow‑up compared with a 4‑week period before the baseline visit. Secondary endpoints were: incidence of minor daytime and nocturnal hypoglycemia, hemoglobin A1c (HbA1c), fasting and postprandial glycemia. RESULTS: The rate of major hypoglycemia decreased in patients with type 1 diabetes – the incidence rate ratio (IRR) was 0.14 for daytime and 0.03 for nocturnal episodes (P <0.0001) and did not change in patients with type 2 diabetes. The rate of minor episodes decreased in patients with type 1 diabetes (IRR = 0.44 for daytime and IRR = 0.24 for nocturnal episodes, P <0.0001) and in patients with type 2 diabetes (IRR= 0.57, P <0.0001 for daytime and IRR = 0.89, P <0.05 for nocturnal episodes). HbA1c decreased by 1.28 ±1.64% in type 1 and 1.25 ±1.10% in type 2 diabetes (both P <0.0001). Self‑measured fasting and postprandial blood glucose levels were significantly lower at the final visit compared with baseline, irrespective of diabetes type. CONCLUSIONS: In clinical practice, treatment with insulin aspart in basal‑bolus regimen is associated with low risk of hypoglycemia and leads to a significant improvement in glucose control, irrespective of diabetes type.