Introduction: Data on switching from premixed insulin to a basal-bolus regimen in routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of switching from twice-daily premixed insulin to basal glargine plus rapid-acting insulin in a "real-world" clinical practice setting in Belgium and The Netherlands.
Methods: This prospective, 6-month, noninterventional, observational study was conducted in 37 centres in Belgium and 19 centres in The Netherlands. Adults (> or =18 years of age) with type 2 diabetes were eligible if they were not taking oral antihyperglycaemic drugs or only taking metformin. The primary objective was the proportion of patients attaining glycated haemoglobin (HbA1c) <7% at months 3 and 6. Secondary objectives included changes in HbA1c, weight, body mass index (BMI), insulin doses, hypoglycaemic events, and treatment satisfaction.
Results: There were 214 patients from Belgium and The Netherlands enrolled. Mean age was 64.6 years, weight was 89.5 kg, BMI was 31.4 kg/m2, and duration of diabetes was 12.1 years. At month 6, the percentage of patients with HbA1c <7% increased from 3.3% to 24.9% (p<0.001). Mean HbA1c at baseline was 8.9%; mean change from baseline was -1.5% (p<0.001). Glargine and prandial insulin doses increased (p<0.001, each), while body weight and BMI were unchanged. Hypoglycaemic events did not increase. Overall treatment satisfaction improved significantly (p<0.001).
Conclusions: In a Belgian and Dutch clinical practice setting, patients with type 2 diabetes that is poorly controlled on premixed insulin experienced significant improvements in glycaemic control, without a concomitant increase in hypoglycaemic events or weight, when switched from premixed insulin to basal-bolus glargine plus rapid-acting insulin. As a result, treatment satisfaction significantly improved.