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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...

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Autores principales: Freemantle, Nick, Mamdani, Muhammad, Vilsbøll, Tina, Kongsø, Jens Harald, Kvist, Kajsa, Bain, Stephen C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2015
Materias:
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.
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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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