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
No Thumbnail Available
Date
2024
Journal Title
Journal ISSN
Volume Title
Publisher
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. © Author(s).
Description
Keywords
2,4 thiazolidinedione derivative , alanine aminotransferase , alkaline phosphatase , alpha glucosidase inhibitor , aspartate aminotransferase , bilirubin , creatinine , dipeptidyl peptidase IV inhibitor , gamma glutamyltransferase , glucagon like peptide 1 receptor agonist , hemoglobin A1c , insulin , insulin derivative , insulin glargine , insulin injection pen , meglitinide , metformin , nicotine , oral antidiabetic agent , sodium glucose cotransporter 2 inhibitor , sulfonylurea , accuracy , adult , alcohol consumption , area under the curve , Article , blood glucose monitoring , body height , body mass , body weight , clinical trial , confounding variable , demographics , Diabetes Treatment Satisfaction Questionnaire , diabetic nephropathy , diabetic neuropathy , diabetic retinopathy , diarrhea , diastolic blood pressure , diet , disease duration , drug dose titration , drug efficacy , drug safety , drug self administration , drug therapy , fasting blood glucose level , follow up , Friedman test , glucose blood level , glycemic control , heart rate , human , hyperglycemia , hypoglycemia , influenza , injection site bleeding , major clinical study , male , middle aged , multicenter study , multivariate analysis , non insulin dependent diabetes mellitus , outcome assessment , prospective study , quality of life , systolic blood pressure , Wilcoxon signed ranks test