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

Abstract

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 comedication (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%CI: 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: Prescription of the rapid-acting insulin analog glulisine was associated with a reduced incidence of macro- and microvascular outcomes in Type 2 diabetes under real-life conditions. Given that this was a retrospective database analysis, it is important to confirm this finding in a randomized controlled trial.