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      Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Patients with T2D Uncontrolled on NPH or Premixed Insulins as Part of Routine Clinical Practice in Bulgaria: ToUPGRADE Study

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          Abstract

          Introduction

          The aim of this study is to demonstrate the real-life effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes (T2D) previously uncontrolled on NPH ± prandial insulin or premixed insulins in routine clinical practice in Bulgaria.

          Methods

          This was a 24-week prospective, observational study performed in 40 inpatient and outpatient sites across the country.

          Results

          A total of 286 patients were included in the study. The mean age (± SD) was 61.2 ± 10.0 years with duration of diabetes of 11.64 ± 7.5 years and body mass index (BMI) of 32.1 ± 5.7 kg/m 2. HbA1c before Gla-300 initiation was 9.8 ± 1.0%, and fasting plasma glucose (FPG) was 13.1 ± 3.4 mmol/L. HbA1c and FPG change from baseline to week 24 was − 1.86% ( p < 0.001) and − 4.8 mmol/L ( p < 0.001), respectively. The proportion of patients reaching their individualized HbA1c at week 24 was 39.1% (95% CI 33.3–45.1%), while the proportion of patients reaching their individualized HbA1c target without confirmed and/or severe hypoglycaemia was 34.8% (95% CI 29.2–40.7%). At study end, 19.0% (95% CI 14.6–24.1%) achieved HbA1c < 7%. Body weight decreased from 88.3 to 87.0 kg from baseline to week 24 with mean change of − 1.3 kg ( p < 0.001). The incidence and event rates of anytime confirmed (≤ 3.9 mmol/L) and/or severe hypoglycaemia were low: 7.7% and 0.42 events per patient-year, respectively. The overall Insulin Treatment Satisfaction Questionnaire (ITSQ) score increased from 53.2 to 78.2 from baseline to week 24 and the difference of 25.1 ± 21.5 points was significant ( p < 0.001).

          Conclusions

          In real-life settings, Gla-300 significantly improved glycaemic control and insulin treatment satisfaction in people with T2D who were inadequately controlled with NPH ± prandial insulin or premixed insulin analogues. Improvement of glycaemic control was associated with a very low risk of hypoglycaemia and with significant weight loss irrespective of the previous insulin regimen.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s13300-021-01022-0.

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          Most cited references16

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          Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

          The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication, and surgical interventions, are recommended. With regards to medication management, for patients with clinical cardiovascular disease, a sodium–glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist with proven cardiovascular benefit is recommended. For patients with chronic kidney disease or clinical heart failure and atherosclerotic cardiovascular disease, an SGLT2 inhibitor with proven benefit is recommended. GLP-1 receptor agonists are generally recommended as the first injectable medication.
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            Real-World Evidence - What Is It and What Can It Tell Us?

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              New insulin glargine 300 Units · mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units · mL-1.

              To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of a new insulin glargine comprising 300 units · mL(-1) (Gla-300), compared with insulin glargine 100 units · mL(-1) (Gla-100) at steady state in people with type 1 diabetes.
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                Author and article information

                Contributors
                zkamenov@hotmail.com
                Journal
                Diabetes Ther
                Diabetes Ther
                Diabetes Therapy
                Springer Healthcare (Cheshire )
                1869-6953
                1869-6961
                19 February 2021
                19 February 2021
                March 2021
                : 12
                : 3
                : 913-930
                Affiliations
                [1 ]GRID grid.410563.5, ISNI 0000 0004 0621 0092, University Hospital “Aleksandrovska”, Medical University of Sofia, ; Sofia, Bulgaria
                [2 ]Sanofi, Sofia, Bulgaria
                [3 ]Diagnostic-Consultative Centre 1, Ruse, Bulgaria
                [4 ]Medical Ambulatory Centre “Asklepii”, Dupnitsa, Bulgaria
                [5 ]Multiprofile Hospital for Active Treatment “Dr. Ivan Seliminski”, Sliven, Bulgaria
                [6 ]Multiprofile Hospital for Active Treatment, Pleven, Bulgaria
                Author information
                http://orcid.org/0000-0002-4829-9449
                Article
                1022
                10.1007/s13300-021-01022-0
                7947095
                33604804
                81fc1e2e-5ad4-4f13-9f65-66da959bc8e9
                © The Author(s) 2021

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 8 October 2020
                : 2 February 2021
                Categories
                Original Research
                Custom metadata
                © The Author(s) 2021

                Endocrinology & Diabetes
                basal insulins,insulin glargine 300 u/ml,observational study,routine clinical practice,real-life effectiveness,toupgrade,type 2 diabetes

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