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


ARSLAN B., Çetinkalp Ş., Kaya A., ERSOY C., Kebapçı N., ÇÖMLEKÇİ A., ...More

Endocrinology Research and Practice, vol.28, no.1, pp.4-11, 2024 (Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 28 Issue: 1
  • Publication Date: 2024
  • Doi Number: 10.5152/erp.2024.23311
  • Journal Name: Endocrinology Research and Practice
  • Journal Indexes: Scopus, TR DİZİN (ULAKBİM)
  • Page Numbers: pp.4-11
  • Keywords: Gla-300, HbA1c, hypoglycemia, insulin, insulin-naïve, OAD, type 2 diabetes mellitus
  • Hacettepe University Affiliated: Yes

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.