Effectiveness of one-year insulin glargine and insulin glulisine basal-bolus treatment in people with type 2 diabetes

Introduction: Being entitled for no patient co-payment, the Hungarian reimbursement condition of analogue insulins as part of basal-bolus treatment in type 2 diabetes mellitus (T2DM) requires that two HbA(1c) levels should achieve <8.0% target value within 12 months (measured two months apart) after switching from treatment with human insulins. Achieving this target, the treatment should be considered effective from drug reimbursement perspective. Aim: The aims of the study were to investigate the effectiveness of insulin glargine + insulin glulisine basal-bolus regimen from the payer's perspective and to investigate the ability to maintain the achieved glycaemic control in previously uncontrolled T2DM patients (HbA(1c)>9.0%). Method: This one-year, non-interventional study included patients with T2DM inadequately controlled (HbA(1c)>9.0%) on previous human basal-bolus treatment. The main outcomes were the proportion of patients who achieved the adequate glycaemic control (defined by the reimbursement rules) and the proportion of patients who achieved reimbursement rules defined HbA(1c)<8.0% target value by the 6 months after switch and could maintain this glycaemic control for upcoming further 6 months. As safety outcome, the hypoglycaemic events were recorded. Results: Out of the 557 patients enrolled, 287 had available data to be included in the efficacy analysis. Out of the 287 efficacy analysis patients, 169 (58.9%) achieved the reimbursement rules defined glycaemic control. At 6 months, 167 patients had HbA(1c) value <8.0% and 152 (91.0%) remained in this target range until the end of the 12-month observational period. Overall, 1221 non-severe and 6 severe hypoglycaemic events were reported. Conclusions: More than half of the patients with T2DM who were newly switched to insulin glargine + glulisine basal-bolus treatment could achieve the reimbursement rule criteria requiring for prescription of the analogue insulins with no co-payment beyond 1 year of treatment in Hungary. However, the results revealed that glycaemic control assessment with HbA(1c) measurements had not met the reimbursement requirements in a significant part of patients.