Effectiveness and safety of initiation and titration of insulin glargine 300 u/ml in insulin-naive patients with type 2 diabetes mellitus uncontrolled on oral antidiabetic drug treatment in Turkey: the EASE study

Abstract

Objective: The aim of the study was to evaluate the effectiveness and safety of insulin glargine 300 U/ mL (Gla-300) in insulin-naive patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drug (OADs) treatment in Turkey. Methods: One hundred eight patients from 20 centers enrolled in the study. Starting from baseline, Gla-300 was self-administered subcutaneously and once daily in the evening. The primary outcome was the mean change in glycated hemoglobin A1c (HbA1c) from baseline to week 24. Results: The mean (+/- SD) Hb1Ac level of 9.4% (+/- 0.8) at baseline decreased to 7.5% (+/- 0.9) at week 12 (P < .1) and to 7.3% (+/- 0.9) at week 24 (P < .1). Although none of the patients were within the target Hb1Ac level of <= 7% at baseline, the percentage of patients who achieved the target Hb1Ac level was 30.4% at week 12 and increased to 42.9% at week 24. Gla-300 treatment achieved the Hb1Ac target in 21 (19.4%) patients without experiencing a hypoglycemic event and in 27 (25.0%) patients who experienced at least one hypoglycemic event. For each self-monitoring blood glucose time point, significant improvements were observed as compared to baseline (P < .001). Statistically significant improvement (P < .001) was seen in the treatment satisfaction questionnaire - status version scores between baseline and week 24. Conclusion: This study indicated that Gla-300 is effective to provide a successful glycemic control with low risk of hypoglycemia added to OADs in insulin-naive patients with T2DM, and it has the potential to improve the quality of life of patients.