Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , , , , , , , |
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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Arquivos de Endocrinologia e Metabolismo (Online) |
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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 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
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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1752122513882611712 |