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

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dc.contributor.authorÇetinarslan B.
dc.contributor.authorÇetinkalp Ş.
dc.contributor.authorKaya A.
dc.contributor.authorErsoy C.
dc.contributor.authorKebapçı N.
dc.contributor.authorÇömlekçi A.
dc.contributor.authorTütüncü N.B.
dc.contributor.authorDeyneli O.
dc.contributor.authorOğuz A.
dc.contributor.authorİlkova H.
dc.contributor.authorYılmaz T.
dc.contributor.authorHekimsoy Z.
dc.contributor.authorÜnübol M.
dc.contributor.authorBalcı M.K.
dc.contributor.authorAtmaca A.
dc.contributor.authorDağdelen S.
dc.contributor.authorYetkin İ.
dc.contributor.authorGüler S.
dc.contributor.authorÖtünç G.
dc.contributor.authorÖzhan L.
dc.date.accessioned2024-07-22T08:01:54Z
dc.date.available2024-07-22T08:01:54Z
dc.date.issued2024
dc.description.abstractObjective: 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. © Author(s).
dc.identifier.DOI-ID10.5152/erp.2024.23311
dc.identifier.issn28226135
dc.identifier.urihttp://akademikarsiv.cbu.edu.tr:4000/handle/123456789/11637
dc.language.isoEnglish
dc.publisherAVES
dc.subject2,4 thiazolidinedione derivative
dc.subjectalanine aminotransferase
dc.subjectalkaline phosphatase
dc.subjectalpha glucosidase inhibitor
dc.subjectaspartate aminotransferase
dc.subjectbilirubin
dc.subjectcreatinine
dc.subjectdipeptidyl peptidase IV inhibitor
dc.subjectgamma glutamyltransferase
dc.subjectglucagon like peptide 1 receptor agonist
dc.subjecthemoglobin A1c
dc.subjectinsulin
dc.subjectinsulin derivative
dc.subjectinsulin glargine
dc.subjectinsulin injection pen
dc.subjectmeglitinide
dc.subjectmetformin
dc.subjectnicotine
dc.subjectoral antidiabetic agent
dc.subjectsodium glucose cotransporter 2 inhibitor
dc.subjectsulfonylurea
dc.subjectaccuracy
dc.subjectadult
dc.subjectalcohol consumption
dc.subjectarea under the curve
dc.subjectArticle
dc.subjectblood glucose monitoring
dc.subjectbody height
dc.subjectbody mass
dc.subjectbody weight
dc.subjectclinical trial
dc.subjectconfounding variable
dc.subjectdemographics
dc.subjectDiabetes Treatment Satisfaction Questionnaire
dc.subjectdiabetic nephropathy
dc.subjectdiabetic neuropathy
dc.subjectdiabetic retinopathy
dc.subjectdiarrhea
dc.subjectdiastolic blood pressure
dc.subjectdiet
dc.subjectdisease duration
dc.subjectdrug dose titration
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdrug self administration
dc.subjectdrug therapy
dc.subjectfasting blood glucose level
dc.subjectfollow up
dc.subjectFriedman test
dc.subjectglucose blood level
dc.subjectglycemic control
dc.subjectheart rate
dc.subjecthuman
dc.subjecthyperglycemia
dc.subjecthypoglycemia
dc.subjectinfluenza
dc.subjectinjection site bleeding
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmiddle aged
dc.subjectmulticenter study
dc.subjectmultivariate analysis
dc.subjectnon insulin dependent diabetes mellitus
dc.subjectoutcome assessment
dc.subjectprospective study
dc.subjectquality of life
dc.subjectsystolic blood pressure
dc.subjectWilcoxon signed ranks test
dc.titleEffectiveness 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
dc.typeArticle

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