Abstract
INTRODUCTION: The IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insulin/other rapid-acting insulin analogues in patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in a real-world setting in Germany. METHODS: Open-label, prospective, multicentre, non-interventional study in Germany. The primary outcome was proportion of patients reaching pre-defined glycosylated haemoglobin A1c (HbA1c) goal at 3, 6, 9 and 12 months. Secondary outcomes included absolute changes in HbA1c, rate of hypoglycaemia and 7-point blood glucose profiles. RESULTS: Overall, 432 (55 T1DM, 377 T2DM) patients were enrolled. Baseline HbA1c was 8.2% (T1DM) and 8.3% (T2DM); individual HbA1c targets were 6.8% and 6.9%, respectively. After insulin glulisine introduction, the proportion of patients achieving their individual HbA1c increased to 43.6% (T1DM) and 39.6% (T2DM) of patients at 12 months. At 12 months, mean HbA1c was reduced by 0.86 ± 1.03% (p < 0.0001) in T1DM and 1.01 ± 1.02 (p < 0.0001) in T2DM. The 7-point blood glucose profile showed a significant reduction in patients with T2DM (p< 0.0001) and a non-significant reduction in T1DM patients. Confirmed symptomatic hypoglycaemia was 5.7% (T1DM) and 1.6% (T2DM). There were no cases of severe hypoglycaemia. CONCLUSION: Switching prandial insulin to insulin glulisine resulted in improved effectiveness with 43.6% of T1DM and 39.6% of T2DM patients reaching their individual pre-defined HbA1c target within 1 year. Switching was safe and was associated with a low rate of hypoglycaemia and adverse events. TRIAL REGISTRATION: https://awbdb.bfarm.de ; Identifier: 6818; Date of registration: 23.06.2016.