rDNA insulin glargine U300 – a critical appraisal

Fei Wang,1 Stefanie Zassman,1 Philip A Goldberg2 1Department of Pharmacy Practice, School of Pharmacy, University of Connecticut, Storrs, CT, USA; 2Department of Internal Medicine, Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA Background: As the first once-daily ba...

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Autores principales: Wang F, Zassman S, Goldberg PA
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Publicado: Dove Medical Press 2016
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spelling oai:doaj.org-article:92f516d457e248bcb6af862fec8ed17c2021-12-02T02:17:44ZrDNA insulin glargine U300 – a critical appraisal1178-7007https://doaj.org/article/92f516d457e248bcb6af862fec8ed17c2016-12-01T00:00:00Zhttps://www.dovepress.com/rdna-insulin-glargine-u300-ndash-a-critical-appraisal-peer-reviewed-article-DMSOhttps://doaj.org/toc/1178-7007Fei Wang,1 Stefanie Zassman,1 Philip A Goldberg2 1Department of Pharmacy Practice, School of Pharmacy, University of Connecticut, Storrs, CT, USA; 2Department of Internal Medicine, Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA Background: As the first once-daily basal insulin analog, insulin glargine 100 U/mL (Gla‑100; Lantus®) rapidly evolved into the most commonly prescribed insulin therapy worldwide. However, this insulin has clinical limitations. The approval of new basal insulin analogs in 2015 has already started to alter the prescribing landscape.Objective: To review the available evidence on the clinical efficacy and safety of a more concentrated insulin glargine (recombinant DNA origin) injection 300 U/mL (Gla-300) compared to insulin Gla-100 in patients with type 1 and type 2 diabetes mellitus (T1DM and T2DM).Methods: The following electronic databases were searched: PubMed and MEDLINE (using Ovid platform), Scopus, BIOSIS, and Google Scholar through June 2016. Conference proceedings of the American Diabetes Association (2015–2016) were reviewed. We also manually searched reference lists of pertinent reviews and trials.Results: A total of 6 pivotal Phase III randomized controlled trials known as the EDITION series were reviewed. All of these trials (n=3,500) were head-to-head comparisons evaluating the efficacy and tolerability of Gla-300 vs Gla-100 in a diverse population with T1DM and T2DM. These trials were of 6 months duration with a 6-month safety extension phase.Conclusion: Gla-300 was as effective as Gla-100 for improving glycemic control over 6 months in all studies, with a lower risk of nocturnal hypoglycemia significant only in insulin-experienced patients with T2DM. Overall, patients on Gla-300 required 10%–18% more basal insulin, but with less weight gain compared with Gla-100. Keywords: basal insulin, glargine 300 U/mL, glargine 100 U/mLWang FZassman SGoldberg PADove Medical Pressarticlebasal insulinglargine 300 U/mlglargine 100 U/mlSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol Volume 9, Pp 425-441 (2016)
institution DOAJ
collection DOAJ
language EN
topic basal insulin
glargine 300 U/ml
glargine 100 U/ml
Specialties of internal medicine
RC581-951
spellingShingle basal insulin
glargine 300 U/ml
glargine 100 U/ml
Specialties of internal medicine
RC581-951
Wang F
Zassman S
Goldberg PA
rDNA insulin glargine U300 – a critical appraisal
description Fei Wang,1 Stefanie Zassman,1 Philip A Goldberg2 1Department of Pharmacy Practice, School of Pharmacy, University of Connecticut, Storrs, CT, USA; 2Department of Internal Medicine, Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA Background: As the first once-daily basal insulin analog, insulin glargine 100 U/mL (Gla‑100; Lantus®) rapidly evolved into the most commonly prescribed insulin therapy worldwide. However, this insulin has clinical limitations. The approval of new basal insulin analogs in 2015 has already started to alter the prescribing landscape.Objective: To review the available evidence on the clinical efficacy and safety of a more concentrated insulin glargine (recombinant DNA origin) injection 300 U/mL (Gla-300) compared to insulin Gla-100 in patients with type 1 and type 2 diabetes mellitus (T1DM and T2DM).Methods: The following electronic databases were searched: PubMed and MEDLINE (using Ovid platform), Scopus, BIOSIS, and Google Scholar through June 2016. Conference proceedings of the American Diabetes Association (2015–2016) were reviewed. We also manually searched reference lists of pertinent reviews and trials.Results: A total of 6 pivotal Phase III randomized controlled trials known as the EDITION series were reviewed. All of these trials (n=3,500) were head-to-head comparisons evaluating the efficacy and tolerability of Gla-300 vs Gla-100 in a diverse population with T1DM and T2DM. These trials were of 6 months duration with a 6-month safety extension phase.Conclusion: Gla-300 was as effective as Gla-100 for improving glycemic control over 6 months in all studies, with a lower risk of nocturnal hypoglycemia significant only in insulin-experienced patients with T2DM. Overall, patients on Gla-300 required 10%–18% more basal insulin, but with less weight gain compared with Gla-100. Keywords: basal insulin, glargine 300 U/mL, glargine 100 U/mL
format article
author Wang F
Zassman S
Goldberg PA
author_facet Wang F
Zassman S
Goldberg PA
author_sort Wang F
title rDNA insulin glargine U300 – a critical appraisal
title_short rDNA insulin glargine U300 – a critical appraisal
title_full rDNA insulin glargine U300 – a critical appraisal
title_fullStr rDNA insulin glargine U300 – a critical appraisal
title_full_unstemmed rDNA insulin glargine U300 – a critical appraisal
title_sort rdna insulin glargine u300 – a critical appraisal
publisher Dove Medical Press
publishDate 2016
url https://doaj.org/article/92f516d457e248bcb6af862fec8ed17c
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