Effectiveness and Safety of Insulin Glulisine When Initiating Supplementary Prandial Insulin Treatment (SIT) in Insulin-Naïve Patients with Type 2 Diabetes: The Observational IGLU-SIT Study

INTRODUCTION: The IGLU-SIT study documented the effectiveness of initiating supplementary prandial insulin treatment (SIT) with insulin glulisine after failure of oral antidiabetic drugs alone in patients with type 2 diabetes (T2DM) in a real-world setting in Germany. METHODS: The IGLU-SIT study was an open-label, prospective, multicentre, non-interventional study with an observation period of 12 ± 1 months. The primary objective was to determine the proportion of patients reaching their pre-defined glycosylated haemoglobin (HbA1c) goal at 3, 6, 9 and 12 months. Selected secondary objectives were absolute change in HbA1c, a 7-point blood glucose profile, and rate of hypoglycaemia. Data were evaluated overall and by age group (< 65, 65–74 and ≥ 75 years). RESULTS: Overall, 215 patients with T2DM were observed in 64 centres. Baseline HbA1c was 8.3%, and mean HbA1c target was 6.8% (baseline 8.1% and target 6.9% in patients ≥ 75 years). Individual HbA1c target attainment in patients peaked at 38.9% (95% confidence interval [CI] 32.1–46.1%) after 12 months; this was 45.9% in patients aged ≥ 75 years. The mean HbA1c reduction was 1.12 ± 1.05% (p < 0.0001) with only minor differences by age group. A 7-point blood glucose profile revealed significant reductions (p < 0.0001) at all time-points. The rate of confirmed symptomatic hypoglycaemia was 2.2% (95% CI 0.7–5.1) during the 12-month follow-up; rates were increased in patients aged ≥ 75 years (7.0%; 95% CI 1.5–19.1) as were the rates of adverse events (17.8 vs. 6.1%). CONCLUSION: Initiating SIT with insulin glulisine is an appropriate treatment option in patients whose T2DM is insufficiently controlled. Particular attention should be paid to elderly patients in whom higher attainment rates of treatment target were associated with adverse events. TRIAL REGISTRATION: https://awbdb.bfarm.de; Identifier: 6819; Date of registration: 23.06.2016