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IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy
INTRODUCTION: IDegLira is a once-daily combination of insulin degludec (IDeg) and liraglutide. Trials directly comparing IDegLira with alternative strategies for intensifying basal insulin are ongoing. While awaiting results, this analysis compared indirectly how different strategies affected glycat...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2015
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674480/ https://www.ncbi.nlm.nih.gov/pubmed/26582052 http://dx.doi.org/10.1007/s13300-015-0142-y |
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author | Freemantle, Nick Mamdani, Muhammad Vilsbøll, Tina Kongsø, Jens Harald Kvist, Kajsa Bain, Stephen C. |
author_facet | Freemantle, Nick Mamdani, Muhammad Vilsbøll, Tina Kongsø, Jens Harald Kvist, Kajsa Bain, Stephen C. |
author_sort | Freemantle, Nick |
collection | PubMed |
description | INTRODUCTION: IDegLira is a once-daily combination of insulin degludec (IDeg) and liraglutide. Trials directly comparing IDegLira with alternative strategies for intensifying basal insulin are ongoing. While awaiting results, this analysis compared indirectly how different strategies affected glycated hemoglobin (HbA(1c)) and other outcomes. METHODS: A pooled analysis of five completed Novo Nordisk randomized clinical trials in patients with type 2 diabetes inadequately controlled on basal insulin was used to compare indirectly IDegLira (N = 199) with: addition of liraglutide to basal insulin (N = 225) [glucagon-like peptide-1 receptor agonist (GLP-1RA) add-on strategy]; basal–bolus (BB) insulin [insulin glargine (IGlar) + insulin aspart] (N = 56); or up-titration of IGlar (N = 329). A supplementary analysis was performed with the BB arm including patients who received IGlar or IDeg as basal insulin in the relevant trial (N = 210). All trials had comparable inclusion/exclusion criteria and baseline characteristics. Individual patient-level data were analyzed using multivariable statistical models with potential baseline heterogeneity accounted for using explanatory variables. RESULTS: At end of study, differences between IDegLira and BB or up-titrated IGlar, respectively, were as follows: reduction in HbA(1c) −0.30%, 95% confidence interval (–0.58; −0.01) and −0.65% (−0.83; −0.47); change in body weight −6.89 kg (−7.92; −5.86) and −4.04 kg (−4.69; −3.40) all in favor of IDegLira. Confirmed hypoglycemia rate was 122.8 (90.7; 166.1), 1060.8 (680.2; 1654.4), and 286.1 (231.1; 354.1) events/100 patient-years for IDegLira, BB, and up-titrated IGlar, respectively. Odds ratios for achieving HbA(1c) <7.0%, <7.0% without hypoglycemia, and <7.0% without hypoglycemia and no weight gain were greater with IDegLira versus up-titrated IGlar. The supplementary analysis yielded similar results to the main analysis. Results with IDegLira were similar to those for the ‘GLP-1RA add-on’ arm. CONCLUSION: These results suggest that IDegLira may be more effective, with lower hypoglycemia rates and less weight gain, than up-titrated basal insulin or BB in patients uncontrolled on basal insulin. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0142-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4674480 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-46744802015-12-17 IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy Freemantle, Nick Mamdani, Muhammad Vilsbøll, Tina Kongsø, Jens Harald Kvist, Kajsa Bain, Stephen C. Diabetes Ther Original Research INTRODUCTION: IDegLira is a once-daily combination of insulin degludec (IDeg) and liraglutide. Trials directly comparing IDegLira with alternative strategies for intensifying basal insulin are ongoing. While awaiting results, this analysis compared indirectly how different strategies affected glycated hemoglobin (HbA(1c)) and other outcomes. METHODS: A pooled analysis of five completed Novo Nordisk randomized clinical trials in patients with type 2 diabetes inadequately controlled on basal insulin was used to compare indirectly IDegLira (N = 199) with: addition of liraglutide to basal insulin (N = 225) [glucagon-like peptide-1 receptor agonist (GLP-1RA) add-on strategy]; basal–bolus (BB) insulin [insulin glargine (IGlar) + insulin aspart] (N = 56); or up-titration of IGlar (N = 329). A supplementary analysis was performed with the BB arm including patients who received IGlar or IDeg as basal insulin in the relevant trial (N = 210). All trials had comparable inclusion/exclusion criteria and baseline characteristics. Individual patient-level data were analyzed using multivariable statistical models with potential baseline heterogeneity accounted for using explanatory variables. RESULTS: At end of study, differences between IDegLira and BB or up-titrated IGlar, respectively, were as follows: reduction in HbA(1c) −0.30%, 95% confidence interval (–0.58; −0.01) and −0.65% (−0.83; −0.47); change in body weight −6.89 kg (−7.92; −5.86) and −4.04 kg (−4.69; −3.40) all in favor of IDegLira. Confirmed hypoglycemia rate was 122.8 (90.7; 166.1), 1060.8 (680.2; 1654.4), and 286.1 (231.1; 354.1) events/100 patient-years for IDegLira, BB, and up-titrated IGlar, respectively. Odds ratios for achieving HbA(1c) <7.0%, <7.0% without hypoglycemia, and <7.0% without hypoglycemia and no weight gain were greater with IDegLira versus up-titrated IGlar. The supplementary analysis yielded similar results to the main analysis. Results with IDegLira were similar to those for the ‘GLP-1RA add-on’ arm. CONCLUSION: These results suggest that IDegLira may be more effective, with lower hypoglycemia rates and less weight gain, than up-titrated basal insulin or BB in patients uncontrolled on basal insulin. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0142-y) contains supplementary material, which is available to authorized users. Springer Healthcare 2015-11-18 2015-12 /pmc/articles/PMC4674480/ /pubmed/26582052 http://dx.doi.org/10.1007/s13300-015-0142-y Text en © The Author(s) 2015 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 Freemantle, Nick Mamdani, Muhammad Vilsbøll, Tina Kongsø, Jens Harald Kvist, Kajsa Bain, Stephen C. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy |
title | IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy |
title_full | IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy |
title_fullStr | IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy |
title_full_unstemmed | IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy |
title_short | IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy |
title_sort | ideglira versus alternative intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin therapy |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674480/ https://www.ncbi.nlm.nih.gov/pubmed/26582052 http://dx.doi.org/10.1007/s13300-015-0142-y |
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