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Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years
BACKGROUND: To study the long-term development (104 weeks) of insulin antibodies during treatment with insulin detemir (IDet) and insulin aspart (IAsp) in children with type 1 diabetes aged 2–16 years. METHODS: A 52-week, two-arm, randomized trial comparing IDet and neutral protamine Hagedorn insuli...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118234/ https://www.ncbi.nlm.nih.gov/pubmed/27600385 http://dx.doi.org/10.1007/s13300-016-0196-5 |
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author | Thalange, Nandu Bereket, Abdullah Jensen, Lisbeth Bjerring Hiort, Line Conradsen Peterkova, Valentina |
author_facet | Thalange, Nandu Bereket, Abdullah Jensen, Lisbeth Bjerring Hiort, Line Conradsen Peterkova, Valentina |
author_sort | Thalange, Nandu |
collection | PubMed |
description | BACKGROUND: To study the long-term development (104 weeks) of insulin antibodies during treatment with insulin detemir (IDet) and insulin aspart (IAsp) in children with type 1 diabetes aged 2–16 years. METHODS: A 52-week, two-arm, randomized trial comparing IDet and neutral protamine Hagedorn insulin, both in combination with IAsp, was followed by a one-arm, 52-week extension trial of the IDet + IAsp arm. The present analysis was conducted in children who completed the randomized trial and entered into the extension trial. RESULTS: Of the 177 children randomized to IDet treatment, 146 entered the extension trial. IDet–IAsp cross-reacting antibodies peaked within the first 39 weeks of treatment before gradually declining. A similar pattern was seen for IDet-specific and IAsp-specific antibodies. At end of trial (EOT), no correlation was observed between the level of IDet-specific or IAsp-specific antibodies or IDet–IAsp cross-reacting antibodies and either glycated hemoglobin (HbA1c) or basal insulin dose. Mean HbA1c was stable during the treatment period, with a slight increase over time from 8.41% (68.4 mmol/mol) at baseline to 8.74% (72 mmol/mol) at EOT. Mean IDet dose increased from 0.43 U/kg at baseline to 0.66 U/kg at EOT. Mean IAsp dose increased from 0.46 U/kg to 0.51 U/kg at EOT. CONCLUSION: Although treatment with IDet and IAsp is associated with development of specific and cross-reacting antibodies, no correlation between insulin antibodies and basal insulin dose or HbA1c was found. FUNDING: Novo Nordisk A/S. ClinicalTrials.gov identifiers: NCT00435019 and NCT00623194. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-016-0196-5) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5118234 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-51182342016-12-05 Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years Thalange, Nandu Bereket, Abdullah Jensen, Lisbeth Bjerring Hiort, Line Conradsen Peterkova, Valentina Diabetes Ther Original Research BACKGROUND: To study the long-term development (104 weeks) of insulin antibodies during treatment with insulin detemir (IDet) and insulin aspart (IAsp) in children with type 1 diabetes aged 2–16 years. METHODS: A 52-week, two-arm, randomized trial comparing IDet and neutral protamine Hagedorn insulin, both in combination with IAsp, was followed by a one-arm, 52-week extension trial of the IDet + IAsp arm. The present analysis was conducted in children who completed the randomized trial and entered into the extension trial. RESULTS: Of the 177 children randomized to IDet treatment, 146 entered the extension trial. IDet–IAsp cross-reacting antibodies peaked within the first 39 weeks of treatment before gradually declining. A similar pattern was seen for IDet-specific and IAsp-specific antibodies. At end of trial (EOT), no correlation was observed between the level of IDet-specific or IAsp-specific antibodies or IDet–IAsp cross-reacting antibodies and either glycated hemoglobin (HbA1c) or basal insulin dose. Mean HbA1c was stable during the treatment period, with a slight increase over time from 8.41% (68.4 mmol/mol) at baseline to 8.74% (72 mmol/mol) at EOT. Mean IDet dose increased from 0.43 U/kg at baseline to 0.66 U/kg at EOT. Mean IAsp dose increased from 0.46 U/kg to 0.51 U/kg at EOT. CONCLUSION: Although treatment with IDet and IAsp is associated with development of specific and cross-reacting antibodies, no correlation between insulin antibodies and basal insulin dose or HbA1c was found. FUNDING: Novo Nordisk A/S. ClinicalTrials.gov identifiers: NCT00435019 and NCT00623194. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-016-0196-5) contains supplementary material, which is available to authorized users. Springer Healthcare 2016-09-06 2016-12 /pmc/articles/PMC5118234/ /pubmed/27600385 http://dx.doi.org/10.1007/s13300-016-0196-5 Text en © The Author(s) 2016 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 Thalange, Nandu Bereket, Abdullah Jensen, Lisbeth Bjerring Hiort, Line Conradsen Peterkova, Valentina Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years |
title | Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years |
title_full | Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years |
title_fullStr | Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years |
title_full_unstemmed | Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years |
title_short | Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2–16 Years |
title_sort | development of insulin detemir/insulin aspart cross-reacting antibodies following treatment with insulin detemir: 104-week study in children and adolescents with type 1 diabetes aged 2–16 years |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118234/ https://www.ncbi.nlm.nih.gov/pubmed/27600385 http://dx.doi.org/10.1007/s13300-016-0196-5 |
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