학술논문
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.
Document Type
Article
Author
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
Source
Subject
*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
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Language
ISSN
2822-6135
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. [ABSTRACT FROM AUTHOR]