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Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland
INTRODUCTION: Insulin glargine 300 U/mL (Gla-300, Toujeo(®)) is a long-acting, once-daily basal insulin with improved—more stable and smoother—pharmacokinetic and pharmacodynamic profiles compared to insulin glargine 100 U/mL (Gla-100) and insulin degludec (IDeg). These properties have been shown to...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2018
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250621/ https://www.ncbi.nlm.nih.gov/pubmed/30302721 http://dx.doi.org/10.1007/s13300-018-0518-x |
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author | Wiesli, Peter Schories, Marcus |
author_facet | Wiesli, Peter Schories, Marcus |
author_sort | Wiesli, Peter |
collection | PubMed |
description | INTRODUCTION: Insulin glargine 300 U/mL (Gla-300, Toujeo(®)) is a long-acting, once-daily basal insulin with improved—more stable and smoother—pharmacokinetic and pharmacodynamic profiles compared to insulin glargine 100 U/mL (Gla-100) and insulin degludec (IDeg). These properties have been shown to translate into an effective HbA1c reduction with the advantage of a lower risk of hypoglycemia in randomized controlled trials of Gla-300 versus Gla-100. In this study, we assessed the effectiveness and safety of Gla-300 under real-world conditions in Switzerland. METHODS: The prospective, observational, open-label, multicenter study TOP-2 explored the effectiveness of Gla-300 in adult patients with type 2 diabetes (T2D) uncontrolled (HbA1c 7.5–10%) on their previous basal insulin in Germany, Austria, and Switzerland. The primary endpoints were the percentages of patients achieving a fasting plasma glucose (FPG) of ≤ 6.1 mmol/L after 6 and 12 months. Secondary endpoints included changes in HbA1c, FPG, body weight, and insulin dose as well as hypoglycemia incidence and safety. Here we report the results for the Swiss patient cohort after 12 months of treatment with insulin glargine 300 U/mL. RESULTS: The 62 patients (33 men) had a mean age of 65 years, a mean diabetes duration of 14 years, a mean body mass index (BMI) of 31 kg/m(2), and were mainly switched from Gla-100 (44%) to Gla-300. The most common concomitant oral anti-diabetes therapy was metformin (65%). The mean individual HbA1c target chosen by the investigators was 7.4%. After 12 months of therapy, Gla-300 significantly reduced mean HbA1c from 8.2% to 7.6% (p < 0.0001). Likewise, Gla-300 significantly reduced mean FPG from 9.1 mmol/L to 7.4 mmol/L (p < 0.0001). At study end, 32% of patients achieved FPG ≤ 6.1 mmol/L, 55% achieved FPG ≤ 7.2 mmol/L , and 57% achieved their individual HbA1c target. Gla-300 was uptitrated to a mean dose of 40 units per day. Symptomatic hypoglycemia incidence after 12 months was low at 9.7% and a rate of 0.23 events per patient year. Body weight remained stable and was not significantly altered during the study. CONCLUSION: Upon switching basaI insulin to Gla-300, overall glucose control significantly improved and glycemic targets were achieved with a low rate of hypoglycemia in T2D patients under real-world conditions in Switzerland. FUNDING: Sanofi–Aventis (Suisse) SA. |
format | Online Article Text |
id | pubmed-6250621 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-62506212018-12-07 Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland Wiesli, Peter Schories, Marcus Diabetes Ther Original Research INTRODUCTION: Insulin glargine 300 U/mL (Gla-300, Toujeo(®)) is a long-acting, once-daily basal insulin with improved—more stable and smoother—pharmacokinetic and pharmacodynamic profiles compared to insulin glargine 100 U/mL (Gla-100) and insulin degludec (IDeg). These properties have been shown to translate into an effective HbA1c reduction with the advantage of a lower risk of hypoglycemia in randomized controlled trials of Gla-300 versus Gla-100. In this study, we assessed the effectiveness and safety of Gla-300 under real-world conditions in Switzerland. METHODS: The prospective, observational, open-label, multicenter study TOP-2 explored the effectiveness of Gla-300 in adult patients with type 2 diabetes (T2D) uncontrolled (HbA1c 7.5–10%) on their previous basal insulin in Germany, Austria, and Switzerland. The primary endpoints were the percentages of patients achieving a fasting plasma glucose (FPG) of ≤ 6.1 mmol/L after 6 and 12 months. Secondary endpoints included changes in HbA1c, FPG, body weight, and insulin dose as well as hypoglycemia incidence and safety. Here we report the results for the Swiss patient cohort after 12 months of treatment with insulin glargine 300 U/mL. RESULTS: The 62 patients (33 men) had a mean age of 65 years, a mean diabetes duration of 14 years, a mean body mass index (BMI) of 31 kg/m(2), and were mainly switched from Gla-100 (44%) to Gla-300. The most common concomitant oral anti-diabetes therapy was metformin (65%). The mean individual HbA1c target chosen by the investigators was 7.4%. After 12 months of therapy, Gla-300 significantly reduced mean HbA1c from 8.2% to 7.6% (p < 0.0001). Likewise, Gla-300 significantly reduced mean FPG from 9.1 mmol/L to 7.4 mmol/L (p < 0.0001). At study end, 32% of patients achieved FPG ≤ 6.1 mmol/L, 55% achieved FPG ≤ 7.2 mmol/L , and 57% achieved their individual HbA1c target. Gla-300 was uptitrated to a mean dose of 40 units per day. Symptomatic hypoglycemia incidence after 12 months was low at 9.7% and a rate of 0.23 events per patient year. Body weight remained stable and was not significantly altered during the study. CONCLUSION: Upon switching basaI insulin to Gla-300, overall glucose control significantly improved and glycemic targets were achieved with a low rate of hypoglycemia in T2D patients under real-world conditions in Switzerland. FUNDING: Sanofi–Aventis (Suisse) SA. Springer Healthcare 2018-10-09 2018-12 /pmc/articles/PMC6250621/ /pubmed/30302721 http://dx.doi.org/10.1007/s13300-018-0518-x Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Wiesli, Peter Schories, Marcus Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland |
title | Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland |
title_full | Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland |
title_fullStr | Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland |
title_full_unstemmed | Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland |
title_short | Improved Glycemic Control with Insulin Glargine 300 U/mL (Toujeo(®)) in Patients with Type 2 Diabetes: Real-World Effectiveness in Switzerland |
title_sort | improved glycemic control with insulin glargine 300 u/ml (toujeo(®)) in patients with type 2 diabetes: real-world effectiveness in switzerland |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250621/ https://www.ncbi.nlm.nih.gov/pubmed/30302721 http://dx.doi.org/10.1007/s13300-018-0518-x |
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