Endocrinology Research and Practice
Original Article

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

1.

Department of Internal Medicine, Division of Endocrinology and Metabolism, Kocaeli University Faculty of Medicine, Kocaeli, Turkey

2.

Department of Endocrinology and Metabolism, Ege University Faculty of Medicine, İzmir, Turkey

3.

Department of Endocrinology and Metabolism, Büyükşehir Hospital, Konya, Turkey

4.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Bursa Uludağ University Faculty of Medicine, Bursa, Turkey

5.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Eskişehir Osmangazi University Faculty of Medicine, Eskişehir, Turkey

6.

Department of Endocrinology and Metabolism, Dokuz Eylül University Faculty of Medicine, İzmir, Turkey

7.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Başkent University Faculty of Medicine, Ankara, Turkey

8.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Koç University Hospital, İstanbul, Turkey

9.

Division of Internal Medicine, İstanbul Medeniyet University Faculty of Medicine, İstanbul, Turkey

10.

Division of Internal Medicine, Department of Endocrinology, Metabolism and Diabetes, İstanbul University, Cerrahpaşa Faculty of Medicine, İstanbul, Turkey

11.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Demiroğlu Bilim University Faculty of Medicine, İstanbul, Turkey

12.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Manisa Celal Bayar University Faculty of Medicine, Manisa, Turkey

13.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Aydın Adnan Menderes University Faculty of Medicine, Aydın, Turkey

14.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Akdeniz University Faculty of Medicine, Antalya, Turkey

15.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Ondokuz Mayıs University Faculty of Medicine, Samsun, Turkey

16.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Hacettepe University Faculty of Medicine, Ankara, Turkey

17.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Gazi University Faculty of Medicine, Ankara, Turkey

18.

Division of Internal Medicine, Department of Endocrinology and Metabolism, Ankara Numune Training and Research Hospital, Ankara, Turkey

19.

Sanofi Pharmaceuticals, İstanbul, Turkey

Endocrinol Res Pract 2024; 28: 4-11
DOI: 10.5152/erp.2024.23311
Read: 699 Downloads: 312 Published: 05 January 2024

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.

Cite this article as: Çetinarslan B, Çetinkalp S, Kaya A, et al. 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. Endocrinol Res Pract. 2024;28(1):4-11.

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