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.
| Autor: | Çetinarslan, Berrin, Çetinkalp, Şevki, Kaya, Ahmet, Ersoy, Canan, Kebapçı, Nur, Çömlekçi, Abdurrahman, Tütüncü, Neslihan Başçıl, Deyneli, Oğuzhan, Oğuz, Aytekin, İlkova, Hasan, Yılmaz, Temel, Hekimsoy, Zeliha, Ünübol, Mustafa, Balcı, Mustafa Kemal, Atmaca, Ayşegül, Dağdelen, Selçuk, Yetkin, İlhan, Güler, Serdar, Ötünç, Göktürk, Özhan, Leyla |
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| Předmět: |
GLYCOSYLATED hemoglobin
DRUG efficacy RESEARCH STATISTICS CLINICAL trials CONFIDENCE intervals INSULIN derivatives ORAL drug administration GLYCEMIC control ONE-way analysis of variance HYPOGLYCEMIC agents PATIENT satisfaction MANN Whitney U Test TYPE 2 diabetes SELF medication RISK assessment RESEARCH funding QUESTIONNAIRES QUALITY of life HYPOGLYCEMIA DESCRIPTIVE statistics REPEATED measures design DATA analysis software FRIEDMAN test (Statistics) DATA analysis PATIENT safety SUBCUTANEOUS injections LONGITUDINAL method DISEASE risk factors EVALUATION |
| Zdroj: | Endocrinology Research & Practice; Jan2024, Vol. 28 Issue 1, p4-11, 8p |
| Abstrakt: | 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. [ABSTRACT FROM AUTHOR] |
| Databáze: | Complementary Index |
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