Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus

Detalhes bibliográficos
Autor(a) principal: Rassi,Nelson
Data de Publicação: 2016
Outros Autores: Moraes,Sandra Maria Campos Teixeira de, Alves,Adriana Ganam, Cavalheiro,Daniela Cunha, Moreira,Josianny Mesquita, Bellório,Karini Bruno, Abreu,Fernanda Cruvinel de, Prata,Paulo Roberto Mendonça, Teixeira,Leonardo de Souza, Rassi,Salvador
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Arquivos de Endocrinologia e Metabolismo (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972016000100047
Resumo: ABSTRACT Objective To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). Subjects and methods Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). Results The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. Conclusion This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.
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spelling Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitusComparative studyNPH insulintype 2 diabetes mellitusglycated hemoglobin Apublic healthABSTRACT Objective To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). Subjects and methods Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). Results The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. Conclusion This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.Sociedade Brasileira de Endocrinologia e Metabologia2016-02-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972016000100047Archives of Endocrinology and Metabolism v.60 n.1 2016reponame:Arquivos de Endocrinologia e Metabolismo (Online)instname:Sociedade Brasileira de Endocrinologia e Metabologia (SBEM)instacron:SBEM10.1590/2359-3997000000140info:eu-repo/semantics/openAccessRassi,NelsonMoraes,Sandra Maria Campos Teixeira deAlves,Adriana GanamCavalheiro,Daniela CunhaMoreira,Josianny MesquitaBellório,Karini BrunoAbreu,Fernanda Cruvinel dePrata,Paulo Roberto MendonçaTeixeira,Leonardo de SouzaRassi,Salvadoreng2016-02-17T00:00:00Zoai:scielo:S2359-39972016000100047Revistahttps://www.aem-sbem.com/https://old.scielo.br/oai/scielo-oai.php||aem.editorial.office@endocrino.org.br2359-42922359-3997opendoar:2016-02-17T00:00Arquivos de Endocrinologia e Metabolismo (Online) - Sociedade Brasileira de Endocrinologia e Metabologia (SBEM)false
dc.title.none.fl_str_mv Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
title Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
spellingShingle Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
Rassi,Nelson
Comparative study
NPH insulin
type 2 diabetes mellitus
glycated hemoglobin A
public health
title_short Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
title_full Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
title_fullStr Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
title_full_unstemmed Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
title_sort Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
author Rassi,Nelson
author_facet Rassi,Nelson
Moraes,Sandra Maria Campos Teixeira de
Alves,Adriana Ganam
Cavalheiro,Daniela Cunha
Moreira,Josianny Mesquita
Bellório,Karini Bruno
Abreu,Fernanda Cruvinel de
Prata,Paulo Roberto Mendonça
Teixeira,Leonardo de Souza
Rassi,Salvador
author_role author
author2 Moraes,Sandra Maria Campos Teixeira de
Alves,Adriana Ganam
Cavalheiro,Daniela Cunha
Moreira,Josianny Mesquita
Bellório,Karini Bruno
Abreu,Fernanda Cruvinel de
Prata,Paulo Roberto Mendonça
Teixeira,Leonardo de Souza
Rassi,Salvador
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Rassi,Nelson
Moraes,Sandra Maria Campos Teixeira de
Alves,Adriana Ganam
Cavalheiro,Daniela Cunha
Moreira,Josianny Mesquita
Bellório,Karini Bruno
Abreu,Fernanda Cruvinel de
Prata,Paulo Roberto Mendonça
Teixeira,Leonardo de Souza
Rassi,Salvador
dc.subject.por.fl_str_mv Comparative study
NPH insulin
type 2 diabetes mellitus
glycated hemoglobin A
public health
topic Comparative study
NPH insulin
type 2 diabetes mellitus
glycated hemoglobin A
public health
description ABSTRACT Objective To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). Subjects and methods Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). Results The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. Conclusion This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.
publishDate 2016
dc.date.none.fl_str_mv 2016-02-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972016000100047
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972016000100047
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/2359-3997000000140
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.publisher.none.fl_str_mv Sociedade Brasileira de Endocrinologia e Metabologia
publisher.none.fl_str_mv Sociedade Brasileira de Endocrinologia e Metabologia
dc.source.none.fl_str_mv Archives of Endocrinology and Metabolism v.60 n.1 2016
reponame:Arquivos de Endocrinologia e Metabolismo (Online)
instname:Sociedade Brasileira de Endocrinologia e Metabologia (SBEM)
instacron:SBEM
instname_str Sociedade Brasileira de Endocrinologia e Metabologia (SBEM)
instacron_str SBEM
institution SBEM
reponame_str Arquivos de Endocrinologia e Metabolismo (Online)
collection Arquivos de Endocrinologia e Metabolismo (Online)
repository.name.fl_str_mv Arquivos de Endocrinologia e Metabolismo (Online) - Sociedade Brasileira de Endocrinologia e Metabologia (SBEM)
repository.mail.fl_str_mv ||aem.editorial.office@endocrino.org.br
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