Micro- and macrovascular outcomes in Type 2 diabetic patients treated with insulin glulisine or human regular insulin: a retrospective database analysis

Objective: Insulin glulisine has a higher efficacy in reducing postprandial glucose excursions and in restoring normal postprandial microcirculation than rapid human insulin. The aim was to compare the incidence of macro- and microvascular outcomes in Type 2 diabetic patients treated with insulin glulisine or regular human insulin. Materials: Computerized data from 952 glulisine (age: 61 +/- 11 y) and 11,157 regular insulin (65 +/- 11 y) users in general practices throughout Germany (Disease Analyzer, 11/2004 to 3/2010) were analyzed. Methods: Hazard ratios (HR; Cox regression) for 3.5-year-risk of macro- or microvascular outcomes were adjusted for age, sex, diabetes duration, diabetologist care, hypertension, hyperlipidemia, depression, and co-medication (basal insulin, oral antidiabetics). Furthermore, adjustment was carried out for baseline microvascular complications when analyzing macrovascular outcomes and vice versa. Results: Overall, risk for macro- or microvascular outcomes was 20% lower for insulin glulisine users (p < 0.05). There was a decreased risk for coronary heart disease (HR; 95%Cl: 0.78; 0.62 - 0.99), and an indication for a lower risk for incident myocardial infarction (HR: 0.66; 0.43 - 1.02). Also for microvascular complications, the adjusted hazard ratios for retinopathy, nephropathy and neuropathy were below 1.0, indicating a lower risk for the insulin glulisine group, however, which was significant for neuropathy only (HR: 0.74; 0.58 - 0.93). Conclusions: Evidence has been presented which indicates that prescription of the rapidly-acting insulin analog glulisine is associated with a reduced incidence of macro- and microvascular outcomes in Type 2 diabetes patients under real-life conditions. Given that this was a retrospective database analysis, where data on patient history, glycemic control and duration of the disease were limited, it is important to confirm this finding in a randomized controlled trial.